Spinal Cord Injury CervicalNCT04383873
Effectiveness Analysis of Armeo Spring Device as a Rehabilitation Treatment in Spinal Cord Injured Patients
A study testing Training by means of Armeo Spring device, Current treatment based on conventional therapy and Additional treatment based on conventional therapy in people with Spinal Cord Injury Cervical, run by Hospital Nacional de Parapléjicos de Toledo at 1 site in Spain.
Trial summary
Loss of motor function is a consequence after a spinal cord injury (SCI). The incidence of SCI varies greatly from 12.1 to 57.8 cases per million depending on the country. More than 50% of people with SCI have impaired upper limb (UL) function, experiencing limitations in performing functional tasks. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Spinal Cord Injury Cervical
- What is being tested?
- Training by means of Armeo Spring device, Current treatment based on conventional therapy and Additional treatment based on conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jun 2016to 28 Dec 2021
- Phase
- Interventional
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cervical lesions above C8, incomplete in the motor aspect or complete with zones of partial motor preservation at least C6, classified according to the ASIA scale.
- Traumatic or non-progressive medical etiology.
- Less than 6 months of injury evolution (subacute).
- Age between 16 and 75 years.
- To have reached the seated posture.
- Be informed and consent to participate in the study.
Who cannot join
- Unstable orthopaedic injuries such as unconsolidated fractures or with unstable osteosynthesis systems in upper limbs.
- Skin lesions and/or pressure ulcers in the exoskeleton placement area.
- Having joint stiffness and/or severe spasticity.
- Bronchopneumopathy and/or severe heart disease that will require monitoring during exercise.
- Visual problems.
- Cognitive impairment.
- Do not sign the corresponding informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Loss of motor function is a consequence after a spinal cord injury (SCI). The incidence of SCI varies greatly from 12.1 to 57.8 cases per million depending on the country. More than 50% of people with SCI have impaired upper limb (UL) function, experiencing limitations in performing functional tasks. In this context, one of the rehabilitation objectives is to achieve the maximum level of independence in the patient in the performance of activities of daily living (ADL).
Within the clinical setting, the main motivation in the use of robotic devices and/or exoskeletons for a rehabilitation purpose focuses on the fact that these help therapists in administering repetitive manual therapies to patients during exercises. There is evidence that the amount of therapy patients receive is insufficient. Without creating additional time demands on clinicians, robotic devices can perform the repetitive mechanical aspects of therapy, increasing the amount of therapy that patients receive. However, the current evidence in stroke patients suggests that the improvements observed are due to the intensity of the therapy, regardless of whether the administration of rehabilitation is due to robotic devices and/or traditional means.
The main objective of this study is to analyze the effectiveness of the commercial Armeo® Spring system (Hocoma AG, Switzerland) and a Virtual Reality application to repeatedly work the ADL from drinking from a glass, in people with cervical SCI. The ADL of drinking has been chosen, as a representative activity of those related to food, which requires control, strength and coordination of the UL. The study is carried out at the Hospital Nacional de Parapléjicos with the collaboration of Occupational Therapy Unit, the Rehabilitation Department, and the Biomechanics and Technical Aids Unit. This effectiveness is measured in terms of functional improvements and in the quality of the UL movements performed.
Read the detailed description
In the literature, there are several studies of the upper limb applied to ADL. The analysis of complete ADL is related to the clinical objectives of the rehabilitative treatment of the UL. An important part of rehabilitation after neurological injuries consists of training activities aimed at fulfilling a function or objective, in which patients have to move their arms continuously repeating certain movement patterns. This is currently one of the main strategies to promote recovery of upper limb function in people who have suffered a spinal cord injury (SCI) o stroke.
Within the clinical setting, the main motivation in the use of robotic devices and/or exoskeletons for a rehabilitation purpose focuses on the fact that these help therapists in administering repetitive manual therapies to patients during exercises. There is evidence that the amount of therapy patients receive is insufficient. Without creating additional time demands on clinicians, robotic devices can perform the repetitive mechanical aspects of therapy, increasing the amount of therapy that patients receive. On the other hand, the use of robotic devices is closely linked to the use of virtual reality (VR) applications. VR interfaces provide feedback to the patient, increasing their level of motivation and adherence to the task during therapy. In this way, therapies with robotic devices and / or exoskeletons increase the amount of rehabilitation, the level of motivation of the patient, and training oriented to fulfill a function or task. Rehabilitation of patients with robotic device-based therapies in addition to traditional therapies could improve functional outcomes. However, the current evidence in stroke patients suggests that the improvements observed are due to the intensity of the therapy, regardless of whether the administration of rehabilitation is due to robotic devices and/or traditional means.
The main objective of this study is to analyze the effectiveness of the commercial Armeo® Spring system (Hocoma AG, Switzerland) and a Virtual Reality application to repeatedly work the ADL from drinking from a glass, in people with cervical SCI. The ADL of drinking has been chosen, as a representative activity of those related to food, which requires control, strength and coordination of the UL. The study is carried out at the Hospital Nacional de Parapléjicos with the collaboration of Occupational Therapy Unit, the Rehabilitation Department, and the Biomechanics and Technical Aids Unit. This effectiveness is measured in terms of functional improvements and in the quality of the UL movements performed.
The secondary objectives are:
- To validate the applicability of the Virtual Reality developed to work the upper limb during the execution of a complete AVD.
- To know the usability and level of acceptance of this therapy in patients with spinal cord injury and UL functional impairments.
- To quantify the differences between the functional patterns of both groups, intervention and control, by means of objective measures, functional scales and measures of the quality of movement, collected in patient evaluations, before, during and after treatment.
- To determine the influence of the RV and the Armeo Spring exoskeleton on the motor recovery of patients with spinal cord injury and UL impairments.
- Conditions
- Spinal Cord Injury Cervical
- Being tested
- Training by means of Armeo Spring device, Current treatment based on conventional therapy, Additional treatment based on conventional therapy
- Keywords
- Effectiveness, Rehabilitation, Upper extremity, Spinal Cord Injury cervical, Robotic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training by means of Armeo Spring deviceDevice
This patients group receive 40 experimental sessions. Each session is based on 30 min by using Armeo Spring device.
Current treatment based on conventional therapyOther
All the patients enrollment in the study receive 30 min of conventional therapy during 40 sessions.
Additional treatment based on conventional therapyOther
This intevention was added for providing the same amount of therapy than those patients randomly enrolled in the intervention group. So, patients in the control group receive other 30 min of conventional therapy added on current treatment during 40 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 17 cervical Spinal Cord injured patients daily receive 1 hour of upper extremity therapy Receives: Device: Training by means of Armeo Spring device; Other: Current treatment based on conventional therapy |
| Control | Active comparator | 17 cervical Spinal Cord injured patients daily receive 1 hour of upper extremity therapy Receives: Other: Current treatment based on conventional therapy; Other: Additional treatment based on conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical scale SCIM
The Spinal Cord Independence Measure (SCIM) is a new disability scale developed specifically for patients with spinal cord lesions in order to make the functional assessments of patients with paraplegia or tetraplegia more sensitive to changes. Exclusively designed for spinal injury. It consists of 3 subscales. The total score varies from 0-100 points, where 0 corresponds to the highest degree of dependency and 100 to the highest degree of independence.
Measured: At baseline
Change from baseline Clinical scale SCIM at 10 weeks
The Spinal Cord Independence Measure (SCIM) is a new disability scale developed specifically for patients with spinal cord lesions in order to make the functional assessments of patients with paraplegia or tetraplegia more sensitive to changes. Exclusively designed for spinal injury. It consists of 3 subscales. The total score varies from 0-100 points, where 0 corresponds to the highest degree of dependency and 100 to the highest degree of independence.
Measured: At the end of the study (at week 10)
Clinical scale CUE
Capabilities of Upper Extremity (CUE) measures upper extremity functional limitations in individuals with tetraplegia. The patient reports the outcome about how well you are able to use the arms and hands of patients. 32 item questionnaire with items in 7 domains. Self-reported measure performed by interview.
Score on 7 points scale representing self-perceived difficulty: 1 (Totally limited, can´t do at all) y 7 (Not at all limited). So, the minimum score is 32 (worse result) and the maximum score 224 (greater function)
Measured: At baseline
Change from baseline Clinical scale CUE at 10 weeks
Capabilities of Upper Extremity (CUE) measures upper extremity functional limitations in individuals with tetraplegia. The patient reports the outcome about how well you are able to use the arms and hands of patients. 32 item questionnaire with items in 7 domains. Self-reported measure performed by interview.
Score on 7 points scale representing self-perceived difficulty: 1 (Totally limited, can´t do at all) y 7 (Not at all limited). So, the minimum score is 32 (worse result) and the maximum score 224 (greater function)
Measured: At the end of the study (at week 10)
Clinical Scale Jebsen-Taylor Hand Function (JTHF)
The Jebsen-Taylor function test was designed to provide a short, objective test of hand functions commonly used in activities of daily living (ADLs). The target patient population includes adults with neurological or musculoskeletal conditions involving hand disabilities, although there may be other patient populations with other hand dysfunctions which may be appropriate. It consists of seven items that include a range of fine motor, weighted and non-weighted hand function activities which are timed: writing (copying) a 24-letter sentence turning over a 3 × 5" cards, picking up small common objects such as a coin and bottle cap, simulated feeding using a teaspoon and five kidney beans, stacking checkers picking up large light objects such as an empty tin can, and picking up and moving large weighted cans. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.
Measured: At baseline
Change from baseline Clinical Scale Jebsen-Taylor Hand Function (JTHF) at 10 weeks
The Jebsen-Taylor function test was designed to provide a short, objective test of hand functions commonly used in activities of daily living (ADLs). The target patient population includes adults with neurological or musculoskeletal conditions involving hand disabilities, although there may be other patient populations with other hand dysfunctions which may be appropriate. It consists of seven items that include a range of fine motor, weighted and non-weighted hand function activities which are timed: writing (copying) a 24-letter sentence turning over a 3 × 5" cards, picking up small common objects such as a coin and bottle cap, simulated feeding using a teaspoon and five kidney beans, stacking checkers picking up large light objects such as an empty tin can, and picking up and moving large weighted cans. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.
Measured: At the end of the study (at week 10)
Clinical scale Nine Hole Peg Test
The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.
Measured: At baseline
Change from baseline Clinical scale Nine Hole Peg Test at 10 weeks
The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.
Measured: At the end of the study (at week 10)
Clinical Scale GRASSP
The GRASSP is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains, important in describing arm and hand function: Strength, Sensation, Prehension. The minimal score is 0 (worse outcome) and the maximum 98 (better outcome) for each hand.
Measured: At baseline
Change from baseline Clinical Scale GRASSP at 10 weeks
The GRASSP is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains, important in describing arm and hand function: Strength, Sensation, Prehension. The minimal score is 0 (worse outcome) and the maximum 98 (better outcome) for each hand.
Measured: At the end of the study (at week 10)
Edinburg Handedness Test
Most people are right handed. The Edinburgh Handedness Inventory is a well known short questionnaire for determining objectively whether one is left or right handed and there is a short form of it. 10 items are valued. The total score is 50 points and the minimum 10 points. The closer score to 50 points, more left-handed the person is. And the closer score to 10 the more right-handed.
Measured: At baseline
Kinematic indices
This assessment is performed by means of photogrammetry. Markers are placed on the trunk and the arm analyzed, and kinematic variables about the UL movement are computed in terms of accuracy, agility, coordination, efficiency and smoothness. A score of 100 in each index corresponds to the healthy pattern. The minimun and worse outcome is 0 score.
Measured: At baseline
Change from baseline Kinematic indices at 10 weeks
This assessment is performed by means of photogrammetry. Markers are placed on the trunk and the arm analyzed, and kinematic variables about the UL movement are computed in terms of accuracy, agility, coordination, efficiency and smoothness. A score of 100 in each index corresponds to the healthy pattern. The minimun and worse outcome is 0 score.
Measured: At the end of the study (at week 10)
Secondary outcomes (8)
Compliance
The total sessions number that the patient has performed and the duration in weeks
Measured: At the end of the study (at week 10)
QUEST usability scale
At ending the treatment using Armeo Spring, patients show their opinion and satisfaction level with the experimental scenario
Measured: At the end of the study (at week 10)
TMS assessment
A transcranial magnetic stimulation-based assessment is made.
Measured: At baseline
Change from baseline TMS assessment at 10 weeks
A transcranial magnetic stimulation-based assessment is made.
Measured: At the end of the study (at week 10)
Beck's Depression Inventory
This depression inventory can be self-scored. The scoring scale is at the end of questionnaire. the BDI consists of 21 items, self-reporting inventory for assessing depression, with 4 alternatives each that are rated from 0 to 3, giving a possible total of 0 to 63 points. The interpretation of the score is as follows: From 1-10 points: These ups and downs are considered normal; from 11-16 points: Slight disturbance of mood; from 17-20 points: Intermittent states of depression. From 21-30 points: Moderate depression. 31-40 points: Severe depression; More than 40 points: Extreme depression.
Measured: At baseline
Change from baseline Beck's Depression Inventory at 10 weeks
This depression inventory can be self-scored. The scoring scale is at the end of questionnaire. the BDI consists of 21 items, self-reporting inventory for assessing depression, with 4 alternatives each that are rated from 0 to 3, giving a possible total of 0 to 63 points. The interpretation of the score is as follows: From 1-10 points: These ups and downs are considered normal; from 11-16 points: Slight disturbance of mood; from 17-20 points: Intermittent states of depression. From 21-30 points: Moderate depression. 31-40 points: Severe depression; More than 40 points: Extreme depression.
Measured: At the end of the study (at week 10)
Hospital Anxiety and Depression Scale (HADS)
The HADS is a questionnaire widely used to evaluate the anxiety and depression. The HADS takes between 2 to 5 minutes to complete. The HAD contains seven subscales for each mood (anxiety and depression). The HAD Scale is an effective screening instrument and ranges of scores are given in order that the proportion of false positives or false negatives may be minimized. Regarding the scores obtained, a score equal to or greater than 11 is considered depression/anxiety. Between 0 and 7 is not considered depression/anxiety, and between 8 and 10 is doubtful case.
Measured: At baseline
Change from baseline Hospital Anxiety and Depression Scale (HADS) at 10 weeks
The HADS is a questionnaire widely used to evaluate the anxiety and depression. The HADS takes between 2 to 5 minutes to complete. The HAD contains seven subscales for each mood (anxiety and depression). The HAD Scale is an effective screening instrument and ranges of scores are given in order that the proportion of false positives or false negatives may be minimized. Regarding the scores obtained, a score equal to or greater than 11 is considered depression/anxiety. Between 0 and 7 is not considered depression/anxiety, and between 8 and 10 is doubtful case.
Measured: At the end of the study (at week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start18 Jun 2016
- Primary completion30 Nov 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional de Parapléjicos de Toledo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana de los Reyes Guzmán, Hospital Nacional de Parapléjicos de Toledo
- Investigators
- Ana de los Reyes, PhD, Principal investigator, Hospital Nacional de Parapléjicos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383873
- Sponsor's protocol ID
- C501/2016
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2020
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Analysis of Armeo Spring Device as a Rehabilitation Treatment in Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT04383873
- Acronym / sponsor ID
- C501/2016
- Conditions
- Spinal Cord Injury Cervical
- Keywords
- Effectiveness, Rehabilitation, Upper extremity, Spinal Cord Injury cervical, Robotic device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospital Nacional de Parapléjicos de ToledoUniversity, hospital or other
- Study start
- 18 Jun 2016 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 12 May 2020 (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.
Loss of motor function is a consequence after a spinal cord injury (SCI). The incidence of SCI varies greatly from 12.1 to 57.8 cases per million depending on the country. More than 50% of people with SCI have impaired upper limb (UL) function, experiencing limitations in performing functional tasks. In this context, one of the rehabilitation objectives is to achieve the maximum level of independence in the patient in the performance of activities of daily living (ADL).
Within the clinical setting, the main motivation in the use of robotic devices and/or exoskeletons for a rehabilitation purpose focuses on the fact that these help therapists in administering repetitive manual therapies to patients during exercises. There is evidence that the amount of therapy patients receive is insufficient. Without creating additional time demands on clinicians, robotic devices can perform the repetitive mechanical aspects of therapy, increasing the amount of therapy that patients receive. However, the current evidence in stroke patients suggests that the improvements observed are due to the intensity of the therapy, regardless of whether the administration of rehabilitation is due to robotic devices and/or traditional means.
The main objective of this study is to analyze the effectiveness of the commercial Armeo® Spring system (Hocoma AG, Switzerland) and a Virtual Reality application to repeatedly work the ADL from drinking from a glass, in people with cervical SCI. The ADL of drinking has been chosen, as a representative activity of those related to food, which requires control, strength and coordination of the UL. The study is carried out at the Hospital Nacional de Parapléjicos with the collaboration of Occupational Therapy Unit, the Rehabilitation Department, and the Biomechanics and Technical Aids Unit. This effectiveness is measured in terms of functional improvements and in the quality of the UL movements performed.
Detailed description
In the literature, there are several studies of the upper limb applied to ADL. The analysis of complete ADL is related to the clinical objectives of the rehabilitative treatment of the UL. An important part of rehabilitation after neurological injuries consists of training activities aimed at fulfilling a function or objective, in which patients have to move their arms continuously repeating certain movement patterns. This is currently one of the main strategies to promote recovery of upper limb function in people who have suffered a spinal cord injury (SCI) o stroke.
Within the clinical setting, the main motivation in the use of robotic devices and/or exoskeletons for a rehabilitation purpose focuses on the fact that these help therapists in administering repetitive manual therapies to patients during exercises. There is evidence that the amount of therapy patients receive is insufficient. Without creating additional time demands on clinicians, robotic devices can perform the repetitive mechanical aspects of therapy, increasing the amount of therapy that patients receive. On the other hand, the use of robotic devices is closely linked to the use of virtual reality (VR) applications. VR interfaces provide feedback to the patient, increasing their level of motivation and adherence to the task during therapy. In this way, therapies with robotic devices and / or exoskeletons increase the amount of rehabilitation, the level of motivation of the patient, and training oriented to fulfill a function or task. Rehabilitation of patients with robotic device-based therapies in addition to traditional therapies could improve functional outcomes. However, the current evidence in stroke patients suggests that the improvements observed are due to the intensity of the therapy, regardless of whether the administration of rehabilitation is due to robotic devices and/or traditional means.
The main objective of this study is to analyze the effectiveness of the commercial Armeo® Spring system (Hocoma AG, Switzerland) and a Virtual Reality application to repeatedly work the ADL from drinking from a glass, in people with cervical SCI. The ADL of drinking has been chosen, as a representative activity of those related to food, which requires control, strength and coordination of the UL. The study is carried out at the Hospital Nacional de Parapléjicos with the collaboration of Occupational Therapy Unit, the Rehabilitation Department, and the Biomechanics and Technical Aids Unit. This effectiveness is measured in terms of functional improvements and in the quality of the UL movements performed.
The secondary objectives are:
- To validate the applicability of the Virtual Reality developed to work the upper limb during the execution of a complete AVD.
- To know the usability and level of acceptance of this therapy in patients with spinal cord injury and UL functional impairments.
- To quantify the differences between the functional patterns of both groups, intervention and control, by means of objective measures, functional scales and measures of the quality of movement, collected in patient evaluations, before, during and after treatment.
- To determine the influence of the RV and the Armeo Spring exoskeleton on the motor recovery of patients with spinal cord injury and UL impairments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Training by means of Armeo Spring device, Other: Current treatment based on conventional therapy17 cervical Spinal Cord injured patients daily receive 1 hour of upper extremity therapy |
| Control | Active comparator | Other: Current treatment based on conventional therapy, Other: Additional treatment based on conventional therapy17 cervical Spinal Cord injured patients daily receive 1 hour of upper extremity therapy |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Cervical lesions above C8, incomplete in the motor aspect or complete with zones of partial motor preservation at least C6, classified according to the ASIA scale.
- Traumatic or non-progressive medical etiology.
- Less than 6 months of injury evolution (subacute).
- Age between 16 and 75 years.
- To have reached the seated posture.
Key exclusion criteria (7 listed)
- Unstable orthopaedic injuries such as unconsolidated fractures or with unstable osteosynthesis systems in upper limbs.
- Skin lesions and/or pressure ulcers in the exoskeleton placement area.
- Having joint stiffness and/or severe spasticity.
- Bronchopneumopathy and/or severe heart disease that will require monitoring during exercise.
- Visual problems.
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 |
|---|---|---|
| Training by means of Armeo Spring deviceThis patients group receive 40 experimental sessions. Each session is based on 30 min by using Armeo Spring device. | Device | Intervention |
| Current treatment based on conventional therapyAll the patients enrollment in the study receive 30 min of conventional therapy during 40 sessions. | Other | Control, Intervention |
| Additional treatment based on conventional therapyThis intevention was added for providing the same amount of therapy than those patients randomly enrolled in the intervention group. So, patients in the control group receive other 30 min of conventional therapy added on current treatment during 40 sessions. | Other | Control |
Primary outcome
Clinical scale SCIM
Time frame: At baseline
The Spinal Cord Independence Measure (SCIM) is a new disability scale developed specifically for patients with spinal cord lesions in order to make the functional assessments of patients with paraplegia or tetraplegia more sensitive to changes. Exclusively designed for spinal injury. It consists of 3 subscales. The total score varies from 0-100 points, where 0 corresponds to the highest degree of dependency and 100 to the highest degree of independence.
Change from baseline Clinical scale SCIM at 10 weeks
Time frame: At the end of the study (at week 10)
The Spinal Cord Independence Measure (SCIM) is a new disability scale developed specifically for patients with spinal cord lesions in order to make the functional assessments of patients with paraplegia or tetraplegia more sensitive to changes. Exclusively designed for spinal injury. It consists of 3 subscales. The total score varies from 0-100 points, where 0 corresponds to the highest degree of dependency and 100 to the highest degree of independence.
Clinical scale CUE
Time frame: At baseline
Capabilities of Upper Extremity (CUE) measures upper extremity functional limitations in individuals with tetraplegia. The patient reports the outcome about how well you are able to use the arms and hands of patients. 32 item questionnaire with items in 7 domains. Self-reported measure performed by interview. Score on 7 points scale representing self-perceived difficulty: 1 (Totally limited, can´t do at all) y 7 (Not at all limited). So, the minimum score is 32 (worse result) and the maximum score 224 (greater function)
Change from baseline Clinical scale CUE at 10 weeks
Time frame: At the end of the study (at week 10)
Capabilities of Upper Extremity (CUE) measures upper extremity functional limitations in individuals with tetraplegia. The patient reports the outcome about how well you are able to use the arms and hands of patients. 32 item questionnaire with items in 7 domains. Self-reported measure performed by interview. Score on 7 points scale representing self-perceived difficulty: 1 (Totally limited, can´t do at all) y 7 (Not at all limited). So, the minimum score is 32 (worse result) and the maximum score 224 (greater function)
Clinical Scale Jebsen-Taylor Hand Function (JTHF)
Time frame: At baseline
The Jebsen-Taylor function test was designed to provide a short, objective test of hand functions commonly used in activities of daily living (ADLs). The target patient population includes adults with neurological or musculoskeletal conditions involving hand disabilities, although there may be other patient populations with other hand dysfunctions which may be appropriate. It consists of seven items that include a range of fine motor, weighted and non-weighted hand function activities which are timed: writing (copying) a 24-letter sentence turning over a 3 × 5" cards, picking up small common objects such as a coin and bottle cap, simulated feeding using a teaspoon and five kidney beans, stacking checkers picking up large light objects such as an empty tin can, and picking up and moving large weighted cans. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.
Change from baseline Clinical Scale Jebsen-Taylor Hand Function (JTHF) at 10 weeks
Time frame: At the end of the study (at week 10)
The Jebsen-Taylor function test was designed to provide a short, objective test of hand functions commonly used in activities of daily living (ADLs). The target patient population includes adults with neurological or musculoskeletal conditions involving hand disabilities, although there may be other patient populations with other hand dysfunctions which may be appropriate. It consists of seven items that include a range of fine motor, weighted and non-weighted hand function activities which are timed: writing (copying) a 24-letter sentence turning over a 3 × 5" cards, picking up small common objects such as a coin and bottle cap, simulated feeding using a teaspoon and five kidney beans, stacking checkers picking up large light objects such as an empty tin can, and picking up and moving large weighted cans. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.
Clinical scale Nine Hole Peg Test
Time frame: At baseline
The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.
Change from baseline Clinical scale Nine Hole Peg Test at 10 weeks
Time frame: At the end of the study (at week 10)
The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.
Clinical Scale GRASSP
Time frame: At baseline
The GRASSP is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains, important in describing arm and hand function: Strength, Sensation, Prehension. The minimal score is 0 (worse outcome) and the maximum 98 (better outcome) for each hand.
Change from baseline Clinical Scale GRASSP at 10 weeks
Time frame: At the end of the study (at week 10)
The GRASSP is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains, important in describing arm and hand function: Strength, Sensation, Prehension. The minimal score is 0 (worse outcome) and the maximum 98 (better outcome) for each hand.
Edinburg Handedness Test
Time frame: At baseline
Most people are right handed. The Edinburgh Handedness Inventory is a well known short questionnaire for determining objectively whether one is left or right handed and there is a short form of it. 10 items are valued. The total score is 50 points and the minimum 10 points. The closer score to 50 points, more left-handed the person is. And the closer score to 10 the more right-handed.
Kinematic indices
Time frame: At baseline
This assessment is performed by means of photogrammetry. Markers are placed on the trunk and the arm analyzed, and kinematic variables about the UL movement are computed in terms of accuracy, agility, coordination, efficiency and smoothness. A score of 100 in each index corresponds to the healthy pattern. The minimun and worse outcome is 0 score.
Change from baseline Kinematic indices at 10 weeks
Time frame: At the end of the study (at week 10)
This assessment is performed by means of photogrammetry. Markers are placed on the trunk and the arm analyzed, and kinematic variables about the UL movement are computed in terms of accuracy, agility, coordination, efficiency and smoothness. A score of 100 in each index corresponds to the healthy pattern. The minimun and worse outcome is 0 score.
8 secondary outcomes
Compliance
Time frame: At the end of the study (at week 10)
QUEST usability scale
Time frame: At the end of the study (at week 10)
TMS assessment
Time frame: At baseline
Change from baseline TMS assessment at 10 weeks
Time frame: At the end of the study (at week 10)
Beck's Depression Inventory
Time frame: At baseline
Change from baseline Beck's Depression Inventory at 10 weeks
Time frame: At the end of the study (at week 10)
Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline
Change from baseline Hospital Anxiety and Depression Scale (HADS) at 10 weeks
Time frame: At the end of the study (at week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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.
Ana de los Reyes, PhD principal investigator
Hospital Nacional de Parapléjicos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training by means of Armeo Spring device, Current treatment based on conventional therapy and Additional treatment based on conventional therapy in people with Spinal Cord Injury Cervical, run by Hospital Nacional de Parapléjicos de Toledo at 1 site in Spain.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 18 Apr 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical scale SCIM (time frame: At baseline). The study lists 13 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 18 Apr 2022.