Wheelchair MobilityNCT06596850
Wheelchair Skills Training for People with ARSACS and DM1
A study testing Wheelchair Skills Training Program in people with Wheelchair Mobility and Manual Wheelchair Skills Training, run by Laval University at 1 site in Canada.
Trial summary
Wheelchairs (WC) are often provided to people with ARSACS and MD1 when they are not able to walk anymore. However, giving someone a MWC alone does not guarantee they will use it safely or properly. Many people who use WC need help from others to get around and they can not always do the things they like to do. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wheelchair Mobility, Manual Wheelchair Skills Training, ARSACS
- What is being tested?
- Wheelchair Skills Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2024to 30 Apr 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age, have a diagnosis of ARSACS or DM1, and use a manual WC for mobility (≥3 times/week for ≥8 hours/week).
Who cannot join
- anticipate a health condition or procedure that contraindicates training (e.g., surgery); or concurrently or planning to receive WC training during the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Interdisciplinary Research in Rehabilitation and Social Integration
Québec, Quebec, G1M 2S8
About this study
Official title: Efficacy of Wheelchair Skills Training to Improve Mobility for People with ARSACS and DM1
Wheelchairs (WC) are often provided to people with ARSACS and MD1 when they are not able to walk anymore. However, giving someone a MWC alone does not guarantee they will use it safely or properly. Many people who use WC need help from others to get around and they can not always do the things they like to do. This can lead to isolation, stress, and reduced quality of life. In addition, poor use of a MWC could lead to accidents and injuries. Our team recently showed that people with ARSACS have lower MWC skills than other adults who use MWC, and that teaching MWC skills to people with ARSACS seems to work. Now we are ready to test the program with more people with ARSACS and MD1 to see how it can improve MWC mobility and confidence. We also want to hear about people's expectations and experiences with MWC training. People who take part in research will answer questions before and after WC training, and we will follow up with them 3 months later to ask again about their WC use.
This projects directly adresses the mobility needs of people with ARSACS and MD1 who use MWC. Our results may improve how therapists provide training for MWC use, which may improve mobility, participation, and quality of life for people with ARSACS and MD1. Learning just one MWC skill could be life-changing. It could mean the difference between leaving the house or not, which could impact the ability to shop for groceries, see friends, or to have a job.
- Being tested
- Wheelchair Skills Training Program
- Medical subject headings
- Spastic ataxia Charlevoix-Saguenay type, Myotonic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair Skills Training ProgramBehavioural
Participants will receive 5, 45-minute weekly WC skills training sessions that will take place in the community, in and around the participants home. Each session will be customized to the participant's' goals and based on the learner's impairments (i.e., weakness, spasticity, movement disorders [e.g. ataxia, tremor], contractures, cognition). The WSTP sessions will begin with a 5-minute review of goals/progress, followed by a 10-minute warm-up (wheeling activities, random practice of previously leaned skills); 20 minutes of attempting new skills (training on each skill will be carried to next session until the skills are learned or until the trainer and participant mutually agree that training should be abandoned; the trainer will periodically ask the participant to practice newly learned skills to incorporate variability of practice); 10 minute cool-down, during which the participant will practice skills in a self-controlled environment.
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair Skills Training Program (WSTP) | Experimental | Standardized wheelchair skills training program. Receives: Behavioral: Wheelchair Skills Training Program |
| Control | No intervention | Wait-list control group where participants will receive usual care from their clinician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheelchair Skills Test Questionnaire (WST-Q)
Subjective report of participants' perceived manual wheelchair skills (performance and frequency). The WST-Q comprises 30 discrete manual WC skills. Skills are scored on a scale ranging from 0 (cannot execute skill) to 3 (can execute skill with expertise); a total percentage score (0-100%) is calculated with higher scores representing greater wheelchair skills. The WST-Q can be completed in ~15 minutes, has strong psychometric properties in English and French, and has been used extensively in clinical trials. The WST-Q has been validated by the study team for ARSACS.
Measured: Baseline (T1); immediately post intervention up to 5 weeks after baseline (T2); 3-months follow-up (T3)
Secondary outcomes (2)
Wheelchair Skills Test (WST)
Objective rating of participants' perceived manual wheelchair skills (capacity). The WST comprises 30 discrete manual WC skills. Skills are scored on a scale ranging from 0 (cannot execute skill) to 3 (can execute skill with expertise); a total percentage score (0-100%) is calculated with higher scores representing greater wheelchair skills. The WST-Q can be completed in ~30 minutes, has strong psychometric properties in English and French, and has been used extensively in clinical trials. The WST-Q has been validated by the study team for ARSACS.
Measured: Baseline (T1); immediately post intervention up to 5 weeks after baseline (T2); 3-months follow-up (T3)
Wheelchair Use Confidence Scale (WheelCon)
WC use confidence (i.e., belief in ability to accomplish specific tasks while using a manual WC) will be assessed using the Wheelchair Use Confidence Scale for Manual Wheelchair Users Short Form (WheelCon-M). The WheelCon-M comprises 21 statements related to confidence using a MWC in activities and environments, each rated on a scale from 0 ("not confident") to 10 ("completely confident"), producing a total mean score between 0 and10. Higher scores represent higher confidence. The WheelCon-M was validated for ARSACS.
Measured: Baseline (T1); immediately post intervention up to 5 weeks after baseline (T2); 3-months follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wheelchair MobilityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596850
- Sponsor's protocol ID
- 2025-3100
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Niyomwungere E, Routhier F, Gagnon C, Kirby RL, Rodrigue X, Lessard I, Lettre J, Best KL. Efficacy of Manual Wheelchair Skills Training for Improving Skills and Confidence in People With Hereditary Degenerative Disorders: Protocol for a Sequential Multimethods Study. JMIR Res Protoc. 2025 Jul 31;14:e66974. doi: 10.2196/66974.
PubMed 40742628
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Wheelchair Skills Training to Improve Mobility for People with ARSACS and DM1
- ClinicalTrials.gov ID
- NCT06596850
- Acronym / sponsor ID
- 2025-3100
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Wheelchairs (WC) are often provided to people with ARSACS and MD1 when they are not able to walk anymore. However, giving someone a MWC alone does not guarantee they will use it safely or properly. Many people who use WC need help from others to get around and they can not always do the things they like to do. This can lead to isolation, stress, and reduced quality of life. In addition, poor use of a MWC could lead to accidents and injuries. Our team recently showed that people with ARSACS have lower MWC skills than other adults who use MWC, and that teaching MWC skills to people with ARSACS seems to work. Now we are ready to test the program with more people with ARSACS and MD1 to see how it can improve MWC mobility and confidence. We also want to hear about people's expectations and experiences with MWC training. People who take part in research will answer questions before and after WC training, and we will follow up with them 3 months later to ask again about their WC use.
This projects directly adresses the mobility needs of people with ARSACS and MD1 who use MWC. Our results may improve how therapists provide training for MWC use, which may improve mobility, participation, and quality of life for people with ARSACS and MD1. Learning just one MWC skill could be life-changing. It could mean the difference between leaving the house or not, which could impact the ability to shop for groceries, see friends, or to have a job.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheelchair Skills Training Program (WSTP) | Experimental | Behavioral: Wheelchair Skills Training ProgramStandardized wheelchair skills training program. |
| Control | No intervention | –Wait-list control group where participants will receive usual care from their clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥18 years of age, have a diagnosis of ARSACS or DM1, and use a manual WC for mobility (≥3 times/week for ≥8 hours/week).
Key exclusion criteria (1 listed)
- anticipate a health condition or procedure that contraindicates training (e.g., surgery); or concurrently or planning to receive WC training during the study.
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 ProgramParticipants will receive 5, 45-minute weekly WC skills training sessions that will take place in the community, in and around the participants home. Each session will be customized to the participant's' goals and based on the learner's impairments (i.e., weakness, spasticity, movement disorders [e.g. ataxia, tremor], contractures, cognition). The WSTP sessions will begin with a 5-minute review of goals/progress, followed by a 10-minute warm-up (wheeling activities, random practice of previously leaned skills); 20 minutes of attempting new skills (training on each skill will be carried to next session until the skills are learned or until the trainer and participant mutually agree that training should be abandoned; the trainer will periodically ask the participant to practice newly learned skills to incorporate variability of practice); 10 minute cool-down, during which the participant will practice skills in a self-controlled environment. | Behavioural | Wheelchair Skills Training Program (WSTP) |
Primary outcome
Wheelchair Skills Test Questionnaire (WST-Q)
Time frame: Baseline (T1); immediately post intervention up to 5 weeks after baseline (T2); 3-months follow-up (T3)
Subjective report of participants' perceived manual wheelchair skills (performance and frequency). The WST-Q comprises 30 discrete manual WC skills. Skills are scored on a scale ranging from 0 (cannot execute skill) to 3 (can execute skill with expertise); a total percentage score (0-100%) is calculated with higher scores representing greater wheelchair skills. The WST-Q can be completed in ~15 minutes, has strong psychometric properties in English and French, and has been used extensively in clinical trials. The WST-Q has been validated by the study team for ARSACS.
2 secondary outcomes
Wheelchair Skills Test (WST)
Time frame: Baseline (T1); immediately post intervention up to 5 weeks after baseline (T2); 3-months follow-up (T3)
Wheelchair Use Confidence Scale (WheelCon)
Time frame: Baseline (T1); immediately post intervention up to 5 weeks after baseline (T2); 3-months follow-up (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40742628Niyomwungere E, Routhier F, Gagnon C, Kirby RL, Rodrigue X, Lessard I, Lettre J, Best KL. Efficacy of Manual Wheelchair Skills Training for Improving Skills and Confidence in People With Hereditary Degenerative Disorders: Protocol for a Sequential Multimethods Study. JMIR Res Protoc. 2025 Jul 31;14:e66974. doi: 10.2196/66974.
- 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.
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 Wheelchair Mobility and Manual Wheelchair Skills Training, run by Laval University at 1 site in Canada.
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 1 inclusion and 1 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 19 Sep 2024. 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 Canada. 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?
Contact Krista L Best, PhD (418-529-9141, krista.best@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheelchair Skills Test Questionnaire (WST-Q) (time frame: Baseline (T1); immediately post intervention up to 5 weeks after baseline (T2); 3-months follow-up (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06596850, which also lists 1 linked publication.
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 19 Sep 2024.