SCI - Spinal Cord InjuryNCT05401734
Robot Assisted Gait Training in Persons With a Spinal Cord Injury
An observational study of SCI - Spinal Cord Injury, run by Thomas More Kempen at 1 site in Belgium.
Trial summary
Over the past decade, RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising, yet a recent study suggested that even though RAGT may improve locomotor ability in the acute SCI population, it appears less functional to more… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Observation and follow up measurement
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2012to 31 Dec 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 50 persons with a SCI will be included in the study. All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre. The recruitment will be performed by word of mouth. Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study. Participation will be strictly voluntary
Who may be able to join
- SCI
- Bone density
Who cannot join
- osteoporosis
- length more than 2 meter
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
De Maesschalck Lieven
Geel, Antwerp, 2440
Lieven De Maesschalck, 0479911974, lieven.demaesschalck@thomasmore.be
About this study
Over the past decade, RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising, yet a recent study suggested that even though RAGT may improve locomotor ability in the acute SCI population, it appears less functional to more conventional forms of ambulation such as wheelchair propulsion.
What most of these studies have neglected to address, however, is the efficacy of RAGT as a therapeutic exercise intervention for the SCI population. Indeed, persons with SCI lead by definition a sedentary lifestyle. This reduced activity can lead to a variety of secondary health complications, including an increased risk for cardiovascular disease, spasticity, altered muscle composition and reduced joint range of motion (ROM), increased risk for pressure sores, reduced bone mineral density, increased risk for osteoporosis, and bladder and bowel dysfunction. In addition, psychological components such as body image, self-esteem, self-efficacy, psychological well-being and quality of life in general may be affected.
Read more
Consequently, before RAGT is dismissed as an expensive but perhaps not superior alternative to conventional rehabilitation strategies after SCI, the potential effect of this therapy on a variety of health-related outcomes needs to be considered, and the potential physiological and psychological benefits associated with this whole-body upright exercise therapy may justify its use in both the acute and chronic SCI populations. Several investigations have already indicated that regular exposure to RAGT results in some very significant health-related benefits that may decrease the aforementioned risk of secondary health complications. To our knowledge however, longitudinal effect studies in the SCI population have not yet been conducted, and further studies are needed to provide definitive evidence. It can be assumed that such insights may further optimize long-term health benefits, but also the cost-benefit ratio of RAGT. In addition, a detailed analysis of RAGT parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed, etc.) and the direct cardiovascular response (heart frequency, blood pressure, blood lactate concentration) to RAGT have not yet been conducted.
The purpose of this research project is therefore to investigate the longitudinal effect of RAGT on the psychological well-being (Quality of Life, pain, fatigue), independence in activities of daily living, muscular strength and joint range of motion (ROM), and bladder and bowel function in persons with SCI.
Read the detailed description
Over the past decade, RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising, yet a recent study suggested that even though RAGT may improve locomotor ability in the acute SCI population, it appears less functional to more conventional forms of ambulation such as wheelchair propulsion.
What most of these studies have neglected to address, however, is the efficacy of RAGT as a therapeutic exercise intervention for the SCI population. Indeed, persons with SCI lead by definition a sedentary lifestyle. This reduced activity can lead to a variety of secondary health complications, including an increased risk for cardiovascular disease, spasticity, altered muscle composition and reduced joint range of motion (ROM), increased risk for pressure sores, reduced bone mineral density, increased risk for osteoporosis, and bladder and bowel dysfunction. In addition, psychological components such as body image, self-esteem, self-efficacy, psychological well-being and quality of life in general may be affected.
Consequently, before RAGT is dismissed as an expensive but perhaps not superior alternative to conventional rehabilitation strategies after SCI, the potential effect of this therapy on a variety of health-related outcomes needs to be considered, and the potential physiological and psychological benefits associated with this whole-body upright exercise therapy may justify its use in both the acute and chronic SCI populations. Several investigations have already indicated that regular exposure to RAGT results in some very significant health-related benefits that may decrease the aforementioned risk of secondary health complications. To our knowledge however, longitudinal effect studies in the SCI population have not yet been conducted, and further studies are needed to provide definitive evidence. It can be assumed that such insights may further optimize long-term health benefits, but also the cost-benefit ratio of RAGT. In addition, a detailed analysis of RAGT parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed, etc.) and the direct cardiovascular response (heart frequency, blood pressure, blood lactate concentration) to RAGT have not yet been conducted.
The purpose of this research project is therefore to investigate the longitudinal effect of RAGT on the psychological well-being (Quality of Life, pain, fatigue), independence in activities of daily living, muscular strength and joint range of motion (ROM), and bladder and bowel function in persons with SCI over a period of 2 years in several cohorts. We will measure every three months. Patients will be asked to fill in the questionnaires 3, 6 9, 12, 15, 18, 21 and 24 months after inclusion. Additionally the patients will we asked to fill in his medication intake in the follow-up system.
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- Observation and follow up measurement
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation and follow up measurementDevice
The measured variables include:
Questionnaires
- Health related quality of life (Health Related Quality of Life Questionnaire)
- Physical activity level (Physical Activity Scale for Persons with Impairments and Disabilities)
- Walking ability (Walking Index for Spinal Cord Injury)
- Independence in activities of daily living (SCIM III Questionnaire)
- Pain (International SCI Pain Basic Data Set)
- Resilience (Resilience Scale)
- Bowel and bladder function (Neurogenic Bowel Dysfunction score, International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms)
Measurements:
- Muscular strength and joint ROM (Manual Muscle Testing)
- Spasticity (Modified Ashworth Scale)
- Walking parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed)
- Cardiovascular response (blood pressure, heart frequency, blood lactate concentration and Borg RPE score)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Approximately 10 persons with a SCI will be included in the study. All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre. The recruitment will be performed by word of mouth. Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study. Participation will be strictly voluntary Receives: Device: Observation and follow up measurement | |
| Cohort 2 | Approximately 10 persons with a SCI will be included in the study. All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre. The recruitment will be performed by word of mouth. Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study. Participation will be strictly voluntary Receives: Device: Observation and follow up measurement | |
| Cohort 3 | Approximately 10 persons with a SCI will be included in the study. All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre. The recruitment will be performed by word of mouth. Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study. Participation will be strictly voluntary Receives: Device: Observation and follow up measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROM (Range of Motion)
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
Measured: 3 months
ROM (Range of Motion)
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
Measured: 6 months
ROM (Range of Motion)
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
Measured: 9 months
ROM (Range of Motion)
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
Measured: 12 months
ROM (Range of Motion)
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
Measured: 15 months
ROM (Range of Motion)
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
Measured: 18 months
ROM (Range of Motion)
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
Measured: 21 months
ROM (Range of Motion)
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
Measured: 24 months
WHOQOL
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
Measured: 3 months
WHOQOL
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
Measured: 6 months
WHOQOL
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
Measured: 9 months
WHOQOL
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
Measured: 12 months
WHOQOL
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
Measured: 15 months
WHOQOL
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 0 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
Measured: 18 months
WHOQOL
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
Measured: 21 months
WHOQOL
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
Measured: 24 months
IPA
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
Measured: 3 months
IPA
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
Measured: 6 months
IPA
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
Measured: 9 months
IPA
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
Measured: 12 months
IPA
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
Measured: 15 months
IPA
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
Measured: 18 months
IPA
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
Measured: 21 months
IPA
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
Measured: 24 months
Bowel and bladder function
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Measured: 3 months
Bowel and bladder function
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Measured: 6 months
Bowel and bladder function
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Measured: 9 months
Bowel and bladder function
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Measured: 12 months
Bowel and bladder function
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Measured: 15 months
Bowel and bladder function
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Measured: 18 months
Bowel and bladder function
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Measured: 21 months
Bowel and bladder function
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Measured: 24 months
Secondary outcomes (8)
Medication
Use of medication. We ask the patient to fill in an digital diary concerning medication intake. We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
Measured: 3 months
Medication
Use of medication. We ask the patient to fill in an digital diary concerning medication intake. We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
Measured: 6 months
Medication
Use of medication. We ask the patient to fill in an digital diary concerning medication intake. We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
Measured: 9 months
Medication
use of medication. We ask the patient to fill in an diary concerning medication.
Measured: 12 months
Medication
Use of medication. We ask the patient to fill in an digital diary concerning medication intake. We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
Measured: 15 months
Medication
Use of medication. We ask the patient to fill in an digital diary concerning medication intake. We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
Measured: 18 months
Medication
Use of medication. We ask the patient to fill in an digital diary concerning medication intake. We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
Measured: 21 months
Medication
Use of medication. We ask the patient to fill in an digital diary concerning medication intake. We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Feb 2012
- Primary completion30 Oct 2014
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Thomas More Kempen
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Herentals
- Responsible party
- Principal investigator, Lieven De Maesschalck, Thomas More Kempen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401734
- Sponsor's protocol ID
- S58158
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot Assisted Gait Training in Persons With a Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05401734
- Acronym / sponsor ID
- S58158
- Conditions
- SCI - Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Thomas More KempenUniversity, hospital or other
- Collaborators
- AZ Herentals
- Study start
- 1 Feb 2012
- Primary completion
- 30 Oct 2014 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the past decade, RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising, yet a recent study suggested that even though RAGT may improve locomotor ability in the acute SCI population, it appears less functional to more conventional forms of ambulation such as wheelchair propulsion.
What most of these studies have neglected to address, however, is the efficacy of RAGT as a therapeutic exercise intervention for the SCI population. Indeed, persons with SCI lead by definition a sedentary lifestyle. This reduced activity can lead to a variety of secondary health complications, including an increased risk for cardiovascular disease, spasticity, altered muscle composition and reduced joint range of motion (ROM), increased risk for pressure sores, reduced bone mineral density, increased risk for osteoporosis, and bladder and bowel dysfunction. In addition, psychological components such as body image, self-esteem, self-efficacy, psychological well-being and quality of life in general may be affected.
Consequently, before RAGT is dismissed as an expensive but perhaps not superior alternative to conventional rehabilitation strategies after SCI, the potential effect of this therapy on a variety of health-related outcomes needs to be considered, and the potential physiological and psychological benefits associated with this whole-body upright exercise therapy may justify its use in both the acute and chronic SCI populations. Several investigations have already indicated that regular exposure to RAGT results in some very significant health-related benefits that may decrease the aforementioned risk of secondary health complications. To our knowledge however, longitudinal effect studies in the SCI population have not yet been conducted, and further studies are needed to provide definitive evidence. It can be assumed that such insights may further optimize long-term health benefits, but also the cost-benefit ratio of RAGT. In addition, a detailed analysis of RAGT parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed, etc.) and the direct cardiovascular response (heart frequency, blood pressure, blood lactate concentration) to RAGT have not yet been conducted.
The purpose of this research project is therefore to investigate the longitudinal effect of RAGT on the psychological well-being (Quality of Life, pain, fatigue), independence in activities of daily living, muscular strength and joint range of motion (ROM), and bladder and bowel function in persons with SCI.
Detailed description
Over the past decade, RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising, yet a recent study suggested that even though RAGT may improve locomotor ability in the acute SCI population, it appears less functional to more conventional forms of ambulation such as wheelchair propulsion.
What most of these studies have neglected to address, however, is the efficacy of RAGT as a therapeutic exercise intervention for the SCI population. Indeed, persons with SCI lead by definition a sedentary lifestyle. This reduced activity can lead to a variety of secondary health complications, including an increased risk for cardiovascular disease, spasticity, altered muscle composition and reduced joint range of motion (ROM), increased risk for pressure sores, reduced bone mineral density, increased risk for osteoporosis, and bladder and bowel dysfunction. In addition, psychological components such as body image, self-esteem, self-efficacy, psychological well-being and quality of life in general may be affected.
Consequently, before RAGT is dismissed as an expensive but perhaps not superior alternative to conventional rehabilitation strategies after SCI, the potential effect of this therapy on a variety of health-related outcomes needs to be considered, and the potential physiological and psychological benefits associated with this whole-body upright exercise therapy may justify its use in both the acute and chronic SCI populations. Several investigations have already indicated that regular exposure to RAGT results in some very significant health-related benefits that may decrease the aforementioned risk of secondary health complications. To our knowledge however, longitudinal effect studies in the SCI population have not yet been conducted, and further studies are needed to provide definitive evidence. It can be assumed that such insights may further optimize long-term health benefits, but also the cost-benefit ratio of RAGT. In addition, a detailed analysis of RAGT parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed, etc.) and the direct cardiovascular response (heart frequency, blood pressure, blood lactate concentration) to RAGT have not yet been conducted.
The purpose of this research project is therefore to investigate the longitudinal effect of RAGT on the psychological well-being (Quality of Life, pain, fatigue), independence in activities of daily living, muscular strength and joint range of motion (ROM), and bladder and bowel function in persons with SCI over a period of 2 years in several cohorts. We will measure every three months. Patients will be asked to fill in the questionnaires 3, 6 9, 12, 15, 18, 21 and 24 months after inclusion. Additionally the patients will we asked to fill in his medication intake in the follow-up system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Observation and follow up measurementApproximately 10 persons with a SCI will be included in the study. All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre. The recruitment will be performed by word of mouth. Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study. Participation will be strictly voluntary |
| Cohort 2 | – | Device: Observation and follow up measurementApproximately 10 persons with a SCI will be included in the study. All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre. The recruitment will be performed by word of mouth. Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study. Participation will be strictly voluntary |
| Cohort 3 | – | Device: Observation and follow up measurementApproximately 10 persons with a SCI will be included in the study. All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre. The recruitment will be performed by word of mouth. Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study. Participation will be strictly voluntary |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 50 persons with a SCI will be included in the study. All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre. The recruitment will be performed by word of mouth. Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study. Participation will be strictly voluntary
Key inclusion criteria (2 listed)
- SCI
- Bone density
Key exclusion criteria (2 listed)
- osteoporosis
- length more than 2 meter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation and follow up measurementThe measured variables include: Questionnaires * Health related quality of life (Health Related Quality of Life Questionnaire) * Physical activity level (Physical Activity Scale for Persons with Impairments and Disabilities) * Walking ability (Walking Index for Spinal Cord Injury) * Independence in activities of daily living (SCIM III Questionnaire) * Pain (International SCI Pain Basic Data Set) * Resilience (Resilience Scale) * Bowel and bladder function (Neurogenic Bowel Dysfunction score, International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms) Measurements: * Muscular strength and joint ROM (Manual Muscle Testing) * Spasticity (Modified Ashworth Scale) * Walking parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed) * Cardiovascular response (blood pressure, heart frequency, blood lactate concentration and Borg RPE score) | Device | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
ROM (Range of Motion)
Time frame: 3 months
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
ROM (Range of Motion)
Time frame: 6 months
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
ROM (Range of Motion)
Time frame: 9 months
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
ROM (Range of Motion)
Time frame: 12 months
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
ROM (Range of Motion)
Time frame: 15 months
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
ROM (Range of Motion)
Time frame: 18 months
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
ROM (Range of Motion)
Time frame: 21 months
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
ROM (Range of Motion)
Time frame: 24 months
Range of Motion. We measure the range of motion of the legs with a Goniometer every three months. Our goal is to see if there is an improvement due to the robot asssited gait training
WHOQOL
Time frame: 3 months
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
WHOQOL
Time frame: 6 months
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
WHOQOL
Time frame: 9 months
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
WHOQOL
Time frame: 12 months
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
WHOQOL
Time frame: 15 months
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
WHOQOL
Time frame: 18 months
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 0 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
WHOQOL
Time frame: 21 months
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
WHOQOL
Time frame: 24 months
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF). We are using the WHOQOL-Bref instrument (questionnaire). The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health. It can be self-administered and has good internal consistency (0.75-0.87). The higher the score, the more QOL. Each item is scored between 1 and 5. This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score. This questionnaire will be filled in every three months by the patient.
IPA
Time frame: 3 months
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
IPA
Time frame: 6 months
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
IPA
Time frame: 9 months
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
IPA
Time frame: 12 months
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
IPA
Time frame: 15 months
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
IPA
Time frame: 18 months
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
IPA
Time frame: 21 months
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
IPA
Time frame: 24 months
Participation of daily life (IPA). This is a valid and reliable questionnaire (Impact on participation and autonomy). This questionnaire is based on the international classification of human functioning. The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling. This questionnaire consist of 32 items divided in 5 domains. (Autonomy outside, family roll, autonomy inside, social relations, work and education). Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers. For each domain a mean score between 0 and 4 will be calculated.
Bowel and bladder function
Time frame: 3 months
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Bowel and bladder function
Time frame: 6 months
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Bowel and bladder function
Time frame: 9 months
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Bowel and bladder function
Time frame: 12 months
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Bowel and bladder function
Time frame: 15 months
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Bowel and bladder function
Time frame: 18 months
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Bowel and bladder function
Time frame: 21 months
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
Bowel and bladder function
Time frame: 24 months
We will use the Neurogenic Bowel Dysfunction score. This valid and reliable questionnaire consist of 10 items. The minimum score is 0 the maximum score is 47. The higher the score, the more discomfort. 0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe. For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It consists 20 items sore between 0-10). 19-76 overall score with greater values indicating increased impact on quality of life.
8 secondary outcomes
Medication
Time frame: 3 months
Medication
Time frame: 6 months
Medication
Time frame: 9 months
Medication
Time frame: 12 months
Medication
Time frame: 15 months
Medication
Time frame: 18 months
Medication
Time frame: 21 months
Medication
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SCI - Spinal Cord Injury, run by Thomas More Kempen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROM (Range of Motion) (time frame: 3 months). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022; AzTrials last refreshed its copy on 2 Nov 2026.