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

July 3, 2025 updated by: Maryam Oskoui, MD, MSc, FRCPC, FAAN

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • Alberta Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jean Mah
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • BC Children's Hospital
        • Principal Investigator:
          • Kathryn Selby
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Recruiting
        • IWK Health Services
        • Contact:
        • Principal Investigator:
          • Jordan Sheriko
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Hospital for SickKids
        • Contact:
        • Principal Investigator:
          • Hernan Gonorazky
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • Centre de readaptation Marie-Enfant
        • Contact:
        • Principal Investigator:
          • Danielle Levac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exergaming Intervention for 8 Weeks
Extension Phase: Participants randomized ot the intervention arm will play Tales from the Magic Keep at home for the 8 week open-label extension phase
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
Active Comparator: Usual Care for 8 weeks.
Extension Phase: Participants randomized to waitlist usual care will play Tales from the Magic Keep at home for the 8 week open-label extension phase
Other: Usual Care
Continue with regularly accessed physical activities and rehabilitation services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with occupational performance
Time Frame: Baseline to 16 weeks
Canadian Occupational Performance Measure (COPM) Satisfaction
Baseline to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independence performing activities of daily living
Time Frame: Baseline to 16 weeks
SMA Independence Scale (SMAIS)
Baseline to 16 weeks
Upper limb motor activity
Time Frame: Baseline to 16 weeks
Median and 99th percentile of upper limb rotational effort and vertical wrist acceleration derived from data captured by the Syde wearable device
Baseline to 16 weeks
Self-reported fatigue
Time Frame: Baseline to 16 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS-SF)
Baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maryam Oskoui, MD, MSc, FRCPC, FAAN

Investigators

  • Principal Investigator: Maryam Oskoui, McGill University
  • Principal Investigator: Danielle Levac, Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-37-2022-7289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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