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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Tales from the Magic Keep™

Exergame targeting upper limb and trunk movement designed for use on the Microsoft Azure Kinect Dose: At least 3 times a week for 20 minutes over 8 weeks (8 hours total) Continue with regularly accessed physical activities and rehabilitation services

OTHER

Usual Care

Continue with regularly accessed physical activities and rehabilitation services

Locations (5)

Alberta Children's Hospital
Calgary, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
IWK Health Services
Halifax, Nova Scotia, Canada
Hospital for SickKids
Toronto, Ontario, Canada
Centre de readaptation Marie-Enfant
Montreal, Quebec, Canada