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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
Led by Maryam Oskoui, MD, MSc, FRCPC, FAAN · Updated on 2025-07-08
22
Participants Needed
5
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of an 8-week home-based upper limb exergaming program compared to usual care for children and youth aged 8 to 18 years with spinal muscular atrophy (SMA). This multisite randomized controlled registry-based trial aims to assess how this intervention impacts occupational satisfaction, an important aspect of daily living for participants with SMA. Participants in the intervention group will play the exergame "Tales from the Magic Keep™" on the Microsoft Azure Kinect platform at home, three times a week for at least 20 minutes each session, totaling 8 hours over 8 weeks. Both groups will continue their usual physical activities and rehabilitation services. After the initial 8 weeks, there is an open-label extension phase where all participants will have the opportunity to play the exergame at home for another 8 weeks. During the study, researchers will assess occupational satisfaction using the Canadian Occupational Performance Measure over 16 weeks. They will also monitor self-reported fatigue, independence in daily activities, and upper limb motor activity. Assessments will be conducted at baseline and follow-up visits, ensuring participant safety and adherence throughout the trial period, which runs until December 2027.
CONDITIONS
Brief Title
A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed genetic diagnosis of 5q spinal muscular atrophy (SMA)
- Aged between 8 and 18 years old at screening
- Able to sit independently without support for at least 10 seconds
- Score of at least 2 points in entry item A of the Revised Upper Limb Module (RULM)
- Treated with disease-modifying therapy
- Signed informed consent form
You will not qualify if you...
- Unable to comply with study procedures as determined by the site investigator before randomization
- Severe scoliosis or contractures interfering with gameplay or functional assessments
- Planned orthopedic surgery within 6 months before or during the intervention and follow-up period (16 weeks)
- Inability to read in English or French
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants in the intervention group play the exergame Tales from the Magic Keep at home 3 times per week for at least 20 minutes over 8 weeks, while continuing their usual physical activities and rehabilitation services. Participants in the usual care group continue their regular physical activities and rehabilitation services without the exergaming intervention.
3 times per week exergaming sessions at home
Duration - 8 weeks after treatment
Participants are assessed for occupational satisfaction, fatigue, independence in daily activities, and upper limb motor activity up to 16 weeks from baseline.
Assessments at baseline, 8 weeks, and 16 weeks
Trial Site Locations
Total: 5 locations
1
Alberta Children's Hospital
Calgary, Alberta, Canada
Actively Recruiting
2
BC Children's Hospital
Vancouver, British Columbia, Canada
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3
IWK Health Services
Halifax, Nova Scotia, Canada
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4
Hospital for SickKids
Toronto, Ontario, Canada
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5
Centre de readaptation Marie-Enfant
Montreal, Quebec, Canada
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Research Team
M
Mbaye Ndiaye
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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