Cerebral PalsyNCT05293093
Effectiveness of the Wheelchair Skills Training Program in People With Complex Movement Disorders
A study testing Wheelchair Skills Training Program in people with Cerebral Palsy, run by KU Leuven at 1 site in Belgium.
Trial summary
The overall goal of this project is to increase independent mobility in populations with complex movement disorders, such as severe cerebral palsy, by adapting The Wheelchair Skills Training Program (WSTP) to the needs and capabilities of this population. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Wheelchair Skills Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Mar 2022to 16 Jan 2023
- 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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of Cerebral Palsy
- classified as level III-V on the Gross Motor Function Classification System
- classified as level III-V on the Manual Ability Classification System
- must be able to understand mobility training instructions
- must be currently using a powered wheelchair
Who cannot join
- underwent surgery of neurological nature less than 12 months prior to the start of the study
- known diagnosis of autism spectrum disorder
- history of traumatic brain injury since diagnosis of cerebral palsy
- history of epilepsy
Trial locations and contacts
1 site in 1 country.
Belgium1 site
KU Leuven Department of Rehabilitation Sciences, Campus Bruges
Bruges, 8200
About this study
Official title: Clinical Evaluation and Effectiveness of the Adapted Wheelchair Skills Training Program in People With Complex Movement Disorders
The overall goal of this project is to increase independent mobility in populations with complex movement disorders, such as severe cerebral palsy, by adapting The Wheelchair Skills Training Program (WSTP) to the needs and capabilities of this population. The primary objective is to evaluate the clinical effectiveness of an adapted Wheelchair Skills Training Program tailored for children with complex movement disorders and its impact on wheelchair mobility skills. Secondary objectives are to evaluate the clinical effectiveness of an adapted Wheelchair Skills Training Program tailored for children with complex movement disorders, and its impact on stress, fatigue, and symptoms of the movement disorder, and to evaluate the clinical effectiveness of an adapted Wheelchair Skills Training Program tailored for children with complex movement disorders, and its impact on participation. The investigators hypothesize an improvement in wheelchair skill capacity and performance post-intervention compared to pre-intervention. In addition, the investigators hypothesize that the levels of stress and fatigue are in the general low to moderate throughout the training sessions. However, the investigators also expect that higher levels of (perceived) stress and fatigue negatively impact task performance and provoke the symptoms of the movement disorder. The investigators hypothesize that participation will improve post-intervention compared to pre-intervention.
Read the detailed description
Powered wheelchair training for individuals with complex movement disorders, such as severe cerebral palsy, is challenging for healthcare providers, funders, and patients: it is highly dependent on the expertise of training staff (e.g., physical and occupational therapists), time-consuming for staff and patients, and therefore costly for providers. Poor personalisation of current training protocols leads to insufficient clinical outcomes. The overall goal of this project is to increase independent mobility in populations with complex movement disorders, such as severe cerebral palsy, by adapting The Wheelchair Skills Training Program (WSTP) to the needs and capabilities of this population.
This study focuses on the effectiveness and clinical evaluation of the Wheelchair Skills Training Program (WSTP), adapted for children with complex movement disorders. Despite the proven effectiveness of the WSTP in other wheelchair-dependent populations, it warrants cautious implementation in clinical and educational settings within our target population of children with Dyskinetic and Spastic CP (GMFCS III- V). The project contains three study objectives. In the first objective, the effectiveness of a powered-wheelchair skill training program (WSTP) tailored for children with complex movement disorders on wheelchair mobility skills will be assessed. In the second study objective, the impact of a powered-wheelchair training session on measures as stress, motivation and fatigue will be evaluated. In the third study objective, the effect on everyday participation and quality of life will be assessed.
The primary endpoint is the wheelchair mobility skill performance, assessed using the Wheelchair Skills Test (WST). This is an objective test of a set of wheelchair skills. It is proven to be a reliable and valid assessment tool and is used in a number of studies as an outcome measure for (powered) wheelchair skills capacity. The main advantage of the WST is that the tester can see how the wheelchair user carries out the skill, permitting problems due to the wheelchair or the technique used to be identified and addressed.
Although WST capacity measures have been found to be sensitive to changes due to training, other measures will also be used to identify training effects on wheelchair mobility skills as recommended. The Wheelchair Skills Test - Questionnaire (WST-Q) will be used as it allows to assess performance as well as capacity and that in subject's own setting which together with WST is recommended for a comprehensive assessment.
Secondary endpoints include measures such as heart rate variability to explore the impact of stress and fatigue on task performance. Emotion Faros 360° devices will be used. Secondary endpoints also include measures of establishing the relationship of the intervention program with the subject's perceived exertion, Intrinsic Motivation Inventory questionnaire, participation by Canadian Occupational Performance Measure (COPM), and quality of life via the CP-QoL.
- Conditions
- Cerebral Palsy
- Being tested
- Wheelchair Skills Training Program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair Skills Training ProgramOther
a standardized training method for users of manual and powered wheelchairs and it combines evidence on motor-skills learning with evidence on how to perform specific wheelchair skills. A recent systematic review and meta-analysis provided evidence that WSTP is a safe and effective intervention that has a clinically meaningful effect on powered wheelchair skill capacity, in particular for new wheelchair users. The WSTP has shown to be effective in several wheelchair-dependent populations and promising to be used in people with complex movement disorders. Yet, adaptation to the specific needs and capabilities of individuals with complex movement disorders is necessary as it has not been assessed in this population. During the 4-week training phase, the participants will receive 3 training sessions per week of 45 minutes, including exercises as described in the Wheelchair Skill Training Program Version 5.1.2
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair Skills Training Program intervention study | Experimental | A one-group pretest-posttest design study will be conducted, consisting of three phases (3- or 5-week baseline phase, 4-week training phase, 4-week retention phase) Receives: Other: Wheelchair Skills Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Wheelchair mobility skill performance at Post-Intervention assessed by the Wheelchair Skills Test (WST).
The change from Baseline Wheelchair mobility skill performance at Post-Intervention will be assessed using the Wheelchair Skills Test (WST). This is an objective test of a set of wheelchair skill tasks, where wheelchair mobility skill performance is scored as a percentage between 0-100% (higher scores indicate a better wheelchair mobility skill performance).
Measured: 4-week Wheelchair Skills Training Program intervention period (starting from the end of the baseline period)
Change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period assessed by the Wheelchair Skills Test (WST).
The change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period will be assessed using the Wheelchair Skills Test (WST). This is an objective test of a set of wheelchair skill tasks, where wheelchair mobility skill performance is scored as a percentage between 0-100% (higher scores indicate a better wheelchair mobility skill performance).
Measured: 4-week retention period (starting from the end of the intervention period)
Secondary outcomes (10)
Monitoring of Heart Rate Variability measured by the eMotion Faros 360° Heart rate variability Sensor during the experiments.
Heart rate variability (HRV) is the fluctuation in the time intervals (in ms) between adjacent heartbeats. The heart rate variability of the participants will be monitored during the training sessions in the intervention period. HRV indexes neurocardiac function and is generated by heart-brain interactions and dynamic non-linear autonomic nervous system processes. HRV is an emergent property of interdependent regulatory systems which operate on different time scales to help persons to adapt to environmental and psychological challenges, and is used as an indicator for stress.
Measured: 11-13 weeks (starting from the beginning of the baseline period until the end of the retention period)
Change in Baseline Participation goals assessed by the Canadian Occupational Performance Measure assessment tool at Post-intervention
The Canadian Occupational Performance Measure assessment tool identifies three participation goals per participant. Each identified goal is scored on 'importance', 'execution' and 'satisfaction' using a 1 - 10 scale (higher scores indicate a better outcome)
Measured: 4-week intervention period (starting from the end of the baseline period)
Change in Post-intervention Participation goals assessed by the Canadian Occupational Performance Measure assessment tool after a 4-week retention period
The Canadian Occupational Performance Measure assessment tool identifies three participation goals per participant. Each identified goal is scored on 'importance', 'execution' and 'satisfaction' using a 1 - 10 scale (higher scores indicate a better outcome)
Measured: 4-week retention period (starting from the end of the intervention period)
Change from Baseline Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) at Post-intervention
The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) comprises 66 items. Items are transformed to a scale with a possible range of 0-100 (higher scores indicate a better outcome).
Measured: 4-week intervention period (starting from the end of the baseline period)
Change from Baseline Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) at Post-intervention
The Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) comprises 88 items. Items are transformed to a scale with a possible range of 0-100 (higher scores indicate a better outcome).
Measured: 4-week intervention period (starting from the end of the baseline period)
Change from Post-intervention Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) after a 4-week retention period
The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) comprises 66 items. Items are transformed to a scale with a possible range of 0-100 (higher scores indicate a better outcome).
Measured: 4-week retention period (starting from the end of the intervention period)
Change from Post-intervention Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) after a 4-week retention period
The Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) comprises 88 items. Items are transformed to a scale with a possible range of 0-100 (higher scores indicate a better outcome).
Measured: 4-week retention period (starting from the end of the intervention period)
Change in Baseline Motivation assessed by the Intrinsic Motivation Inventory questionnaire at Post-intervention
The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement device intended to assess participants' subjective experience related to a target activity. The instrument assesses participants' interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, relatedness, and perceived choice while performing a given activity, thus yielding seven subscale scores. The questionnaire used in the study comprises 14 items (two items per subscale) transformed to a score with a possible range of 0-14 (higher scores indicate a better outcome).
Measured: 4-week intervention period (starting from the end of the baseline period)
Change from Baseline Wheelchair mobility skill performance at Post-Intervention assessed by the Wheelchair Skills Test-Questionnaire (WST-Q).
The change from Baseline Wheelchair mobility skill performance at Post-Intervention will be assessed using the Wheelchair Skills Test-Questionnaire (WST-Q). This questionnaire evaluates the (perceived) capacity and performance of a set of wheelchair skill tasks, where wheelchair mobility skill performance is scored as a percentage between 0-100% (higher scores indicate a better wheelchair mobility skill performance).
Measured: 4-week intervention period (starting from the end of the baseline period)
Change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period assessed by the Wheelchair Skills Test-Questionnaire (WST-Q).
The change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period will be assessed using the Wheelchair Skills Test-Questionnaire (WST-Q). This questionnaire evaluates the (perceived) capacity and performance of a set of wheelchair skill tasks, where wheelchair mobility skill performance is scored as a percentage between 0-100% (higher scores indicate a better wheelchair mobility skill performance).
Measured: 4-week retention period (starting from the end of the intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start2 Mar 2022
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A one-group pretest-posttest design study will be conducted, consisting of three phases (3- or 5-week baseline phase, 4-week training phase, 4-week retention phase) and four wheelchair skill capacity assessment points (T0: baseline; T1: pre-intervention; T2: post-intervention; T3: retention).
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elegast Monbaliu, KU Leuven
- Investigators
- Elegast Monbaliu, PhD, Principal investigator, KU Leuven Department of Rehabilitation Sciences, Campus Bruges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293093
- Sponsor's protocol ID
- S65462
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation and Effectiveness of the Adapted Wheelchair Skills Training Program in People With Complex Movement Disorders
- ClinicalTrials.gov ID
- NCT05293093
- Acronym / sponsor ID
- S65462
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 24 Mar 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.
The overall goal of this project is to increase independent mobility in populations with complex movement disorders, such as severe cerebral palsy, by adapting The Wheelchair Skills Training Program (WSTP) to the needs and capabilities of this population. The primary objective is to evaluate the clinical effectiveness of an adapted Wheelchair Skills Training Program tailored for children with complex movement disorders and its impact on wheelchair mobility skills. Secondary objectives are to evaluate the clinical effectiveness of an adapted Wheelchair Skills Training Program tailored for children with complex movement disorders, and its impact on stress, fatigue, and symptoms of the movement disorder, and to evaluate the clinical effectiveness of an adapted Wheelchair Skills Training Program tailored for children with complex movement disorders, and its impact on participation. The investigators hypothesize an improvement in wheelchair skill capacity and performance post-intervention compared to pre-intervention. In addition, the investigators hypothesize that the levels of stress and fatigue are in the general low to moderate throughout the training sessions. However, the investigators also expect that higher levels of (perceived) stress and fatigue negatively impact task performance and provoke the symptoms of the movement disorder. The investigators hypothesize that participation will improve post-intervention compared to pre-intervention.
Detailed description
Powered wheelchair training for individuals with complex movement disorders, such as severe cerebral palsy, is challenging for healthcare providers, funders, and patients: it is highly dependent on the expertise of training staff (e.g., physical and occupational therapists), time-consuming for staff and patients, and therefore costly for providers. Poor personalisation of current training protocols leads to insufficient clinical outcomes. The overall goal of this project is to increase independent mobility in populations with complex movement disorders, such as severe cerebral palsy, by adapting The Wheelchair Skills Training Program (WSTP) to the needs and capabilities of this population.
This study focuses on the effectiveness and clinical evaluation of the Wheelchair Skills Training Program (WSTP), adapted for children with complex movement disorders. Despite the proven effectiveness of the WSTP in other wheelchair-dependent populations, it warrants cautious implementation in clinical and educational settings within our target population of children with Dyskinetic and Spastic CP (GMFCS III- V). The project contains three study objectives. In the first objective, the effectiveness of a powered-wheelchair skill training program (WSTP) tailored for children with complex movement disorders on wheelchair mobility skills will be assessed. In the second study objective, the impact of a powered-wheelchair training session on measures as stress, motivation and fatigue will be evaluated. In the third study objective, the effect on everyday participation and quality of life will be assessed.
The primary endpoint is the wheelchair mobility skill performance, assessed using the Wheelchair Skills Test (WST). This is an objective test of a set of wheelchair skills. It is proven to be a reliable and valid assessment tool and is used in a number of studies as an outcome measure for (powered) wheelchair skills capacity. The main advantage of the WST is that the tester can see how the wheelchair user carries out the skill, permitting problems due to the wheelchair or the technique used to be identified and addressed.
Although WST capacity measures have been found to be sensitive to changes due to training, other measures will also be used to identify training effects on wheelchair mobility skills as recommended. The Wheelchair Skills Test - Questionnaire (WST-Q) will be used as it allows to assess performance as well as capacity and that in subject's own setting which together with WST is recommended for a comprehensive assessment.
Secondary endpoints include measures such as heart rate variability to explore the impact of stress and fatigue on task performance. Emotion Faros 360° devices will be used. Secondary endpoints also include measures of establishing the relationship of the intervention program with the subject's perceived exertion, Intrinsic Motivation Inventory questionnaire, participation by Canadian Occupational Performance Measure (COPM), and quality of life via the CP-QoL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A one-group pretest-posttest design study will be conducted, consisting of three phases (3- or 5-week baseline phase, 4-week training phase, 4-week retention phase) and four wheelchair skill capacity assessment points (T0: baseline; T1: pre-intervention; T2: post-intervention; T3: retention).
| Arm | Type | Receives |
|---|---|---|
| Wheelchair Skills Training Program intervention study | Experimental | Other: Wheelchair Skills Training ProgramA one-group pretest-posttest design study will be conducted, consisting of three phases (3- or 5-week baseline phase, 4-week training phase, 4-week retention phase) |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- clinical diagnosis of Cerebral Palsy
- classified as level III-V on the Gross Motor Function Classification System
- classified as level III-V on the Manual Ability Classification System
- must be able to understand mobility training instructions
- must be currently using a powered wheelchair
Key exclusion criteria (4 listed)
- underwent surgery of neurological nature less than 12 months prior to the start of the study
- known diagnosis of autism spectrum disorder
- history of traumatic brain injury since diagnosis of cerebral palsy
- history of epilepsy
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 |
|---|---|---|
| Wheelchair Skills Training Programa standardized training method for users of manual and powered wheelchairs and it combines evidence on motor-skills learning with evidence on how to perform specific wheelchair skills. A recent systematic review and meta-analysis provided evidence that WSTP is a safe and effective intervention that has a clinically meaningful effect on powered wheelchair skill capacity, in particular for new wheelchair users. The WSTP has shown to be effective in several wheelchair-dependent populations and promising to be used in people with complex movement disorders. Yet, adaptation to the specific needs and capabilities of individuals with complex movement disorders is necessary as it has not been assessed in this population. During the 4-week training phase, the participants will receive 3 training sessions per week of 45 minutes, including exercises as described in the Wheelchair Skill Training Program Version 5.1.2 | Other | Wheelchair Skills Training Program intervention study |
Primary outcome
Change from Baseline Wheelchair mobility skill performance at Post-Intervention assessed by the Wheelchair Skills Test (WST).
Time frame: 4-week Wheelchair Skills Training Program intervention period (starting from the end of the baseline period)
The change from Baseline Wheelchair mobility skill performance at Post-Intervention will be assessed using the Wheelchair Skills Test (WST). This is an objective test of a set of wheelchair skill tasks, where wheelchair mobility skill performance is scored as a percentage between 0-100% (higher scores indicate a better wheelchair mobility skill performance).
Change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period assessed by the Wheelchair Skills Test (WST).
Time frame: 4-week retention period (starting from the end of the intervention period)
The change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period will be assessed using the Wheelchair Skills Test (WST). This is an objective test of a set of wheelchair skill tasks, where wheelchair mobility skill performance is scored as a percentage between 0-100% (higher scores indicate a better wheelchair mobility skill performance).
10 secondary outcomes
Monitoring of Heart Rate Variability measured by the eMotion Faros 360° Heart rate variability Sensor during the experiments.
Time frame: 11-13 weeks (starting from the beginning of the baseline period until the end of the retention period)
Change in Baseline Participation goals assessed by the Canadian Occupational Performance Measure assessment tool at Post-intervention
Time frame: 4-week intervention period (starting from the end of the baseline period)
Change in Post-intervention Participation goals assessed by the Canadian Occupational Performance Measure assessment tool after a 4-week retention period
Time frame: 4-week retention period (starting from the end of the intervention period)
Change from Baseline Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) at Post-intervention
Time frame: 4-week intervention period (starting from the end of the baseline period)
Change from Baseline Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) at Post-intervention
Time frame: 4-week intervention period (starting from the end of the baseline period)
Change from Post-intervention Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) after a 4-week retention period
Time frame: 4-week retention period (starting from the end of the intervention period)
Change from Post-intervention Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) after a 4-week retention period
Time frame: 4-week retention period (starting from the end of the intervention period)
Change in Baseline Motivation assessed by the Intrinsic Motivation Inventory questionnaire at Post-intervention
Time frame: 4-week intervention period (starting from the end of the baseline period)
Change from Baseline Wheelchair mobility skill performance at Post-Intervention assessed by the Wheelchair Skills Test-Questionnaire (WST-Q).
Time frame: 4-week intervention period (starting from the end of the baseline period)
Change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period assessed by the Wheelchair Skills Test-Questionnaire (WST-Q).
Time frame: 4-week retention period (starting from the end of the intervention period)
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 2 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Elegast Monbaliu, PhD principal investigator
KU Leuven Department of Rehabilitation Sciences, Campus Bruges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheelchair Skills Training Program in people with Cerebral Palsy, run by KU Leuven 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 5 inclusion and 4 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 2 Mar 2023. 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?
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?
Change from Baseline Wheelchair mobility skill performance at Post-Intervention assessed by the Wheelchair Skills Test (WST). (time frame: 4-week Wheelchair Skills Training Program intervention period (starting from the end of the baseline period)). The study lists 2 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 Mar 2023.