A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy
Recruiting now · Not applicable
Conditions studied: Spinal Muscular Atrophy
In brief
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).
Key facts
- Study ID
- NCT06396325
- Run by
- Maryam Oskoui, MD, MSc, FRCPC, FAAN
- People needed
- 22
- Starts
- 2024-11-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-07-08
Who can join
Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Inability to comply with study procedures according to the site investigator, prior to randomization
- Severe scoliosis or contractures that would interfere with gameplay or with successful completion of functional assessments, as confirmed by the clinical evaluator
- Planned orthopedic surgery 6 months prior to or throughout intervention and follow-up period (16 weeks post randomization)
- Inability to read in English or French
Where it is running
- Alberta Children's Hospital — Calgary, Alberta, Canada (enrolling)
- BC Children's Hospital — Vancouver, British Columbia, Canada (enrolling)
- IWK Health Services — Halifax, Nova Scotia, Canada (enrolling)
- Hospital for SickKids — Toronto, Ontario, Canada (enrolling)
- Centre de readaptation Marie-Enfant — Montreal, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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