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

Last updated: November 1, 2024
Sponsor: Maryam Oskoui, MD, MSc, FRCPC, FAAN
Overall Status: Active - Recruiting

Phase

N/A

Condition

Muscular Dystrophy

Spinal Muscular Atrophy

Myasthenia Gravis (Chronic Weakness)

Treatment

Tales from the Magic Keep™

Exergaming

Usual Care

Clinical Study ID

NCT06396325
MP-37-2022-7289
  • Ages 8-18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 10seconds

  • 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 themouth")

  • Treated with disease-modifying therapy

  • Signed ICF

Exclusion

Exclusion Criteria:

  • Inability to comply with study procedures according to the site investigator, priorto randomization

  • Severe scoliosis or contractures that would interfere with gameplay or withsuccessful completion of functional assessments, as confirmed by the clinicalevaluator

  • Planned orthopedic surgery 6 months prior to or throughout intervention andfollow-up period (16 weeks post randomization)

  • Inability to read in English or French

Study Design

Total Participants: 22
Treatment Group(s): 3
Primary Treatment: Tales from the Magic Keep™
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
December 31, 2027

Study Description

This multisite randomized controlled registry-based trial will evaluate the efficacy of a home-based exergaming intervention, as compared to usual care, on occupational satisfaction of children and youth (aged 8-18 years old) with SMA. Participants in the intervention arm will play the exergame, Tales from the Magic Keep™ on the Azure Kinect platform, 3 times per week, for at least 20 minutes, over 8 weeks (total 8 hours), and continue to access their regular physical activities and rehabilitation services. Those in the usual care arm will continue to access their regular physical activities and rehabilitation services. Occupational satisfaction will be assessed using the Canadian Occupational Performance Measure (COPM) at 8 weeks.

Connect with a study center

  • Alberta Children's Hospital

    Calgary, Alberta
    Canada

    Site Not Available

  • BC Children's Hospital

    Vancouver, British Columbia
    Canada

    Site Not Available

  • IWK Health Services

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • Hospital for SickKids

    Toronto, Ontario
    Canada

    Site Not Available

  • Centre de readaptation Marie-Enfant

    Montreal, Quebec
    Canada

    Active - Recruiting

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