A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy
Key facts
- Where
- Calgary, Halifax, Montreal, Toronto és Vancouver, KanadaSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 18 years old?
Forrás: NCT06396325: ki vehet részt
Where in Kanada
- Alberta Children's HospitalCalgary, KanadaTaking people
- IWK Health ServicesHalifax, KanadaTaking people
- Centre de readaptation Marie-EnfantMontreal, KanadaTaking people
- Hospital for SickKidsToronto, KanadaTaking people
- BC Children ' s HospitalVancouver, KanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maryam Oskoui, MD, MSc, FRCPC, FAAN
- Trial code
- NCT06396325
- Record updated
- 2025. július 8.
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: 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); 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.