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A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy

RecruitingNAAges 8 Years - 18 YearsAllMaryam Oskoui, MD, MSc, FRCPC, FAAN
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In plain words

What the trial is, and whether it could suit you

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).

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Tales from the Magic Keepโ„ข
  • Usual Care
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Where

5 sites
Alberta Children's Hospital
Calgary, Canada
BC Children's Hospital
Vancouver, Canada
IWK Health Services
Halifax, Canada
Hospital for SickKids
Toronto, Canada
Centre de readaptation Marie-Enfant
Montreal, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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