NCT06396325Recruiting
A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy
A Registry-Based Parallel Group Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy, With an Optional Open-Label Extension
Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a multisite randomized controlled registry-based trial to evaluate the efficacy of an 8-week home-based exergaming intervention as compared to usual care on occupational satisfaction of children and youth (8-18 years old age) with spinal muscular atrophy (SMA).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 29 Apr 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Maryam Oskoui, MD, MSc, FRCPC, FAAN
- Diseases
- Spinal muscular atrophy
- NCT number
- NCT06396325
What you commit to
- Study type: Interventional
- Planned participants: 22
- From 1 Nov 2024 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to comply with study procedures according to the site investigator, prior to randomization
- Planned orthopedic surgery 6 months prior to or throughout intervention and follow-up period (16 weeks post randomization)
Other
- Severe scoliosis or contractures that would interfere with gameplay or with successful completion of functional assessments, as confirmed by the clinical evaluator
- Inability to read in English or French
Who the study is looking for
- Confirmed genetic diagnosis of 5q SMA
- Age at screening: Aged 8-18 years old
- Participant is able to stay seated independently without support for at least 10 seconds
- Participants has a score of at least 2 points in entry item A of the RULM (i.e., "Can raise 1 or 2 hands to the mouth but cannot raise a 200 g weight in it to the mouth")
- Treated with disease-modifying therapy
- Signed ICF
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alberta Children's Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| IWK Health Services Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| Centre de readaptation Marie-Enfant Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Hospital for SickKids Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| BC Children ' s Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.