Home-based exergaming for children 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

This study is testing if playing a fun video game at home can help kids and teens with spinal muscular atrophy feel happier and more engaged in their daily activities.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 8 Years to 18 Years
• Sex: All
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (Academic / other)
• Locations: 5 sites (Calgary, Alberta and 4 other locations)
• Trial ID: NCT06396325 on ClinicalTrials.gov

What this trial studies

This multisite randomized controlled trial evaluates the effectiveness of an 8-week home-based exergaming intervention, using the game Tales from the Magic Keep™, for children and adolescents aged 8-18 with spinal muscular atrophy (SMA). Participants in the intervention group will engage in exergaming three times a week for at least 20 minutes, while those in the control group will receive usual care. The primary outcome measure will be occupational satisfaction, assessed using the Canadian Occupational Performance Measure (COPM) after the intervention period. The study aims to determine if exergaming can enhance the quality of life and engagement in activities for these young patients.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 8-18 with a confirmed genetic diagnosis of 5q spinal muscular atrophy who can sit independently.

Not a fit: Patients with severe scoliosis or contractures that interfere with gameplay or those who cannot comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could improve occupational satisfaction and overall quality of life for children with spinal muscular atrophy.

How similar studies have performed: Other studies have shown promise in using exergaming for rehabilitation, suggesting potential success for this approach in similar populations.

Eligibility criteria

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

Where this trial is running

Calgary, Alberta and 4 other locations

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

Study contacts

• Principal investigator: Maryam Oskoui — McGill University
• Study coordinator: Mbaye Ndiaye

Conditions Spinal Muscular Atrophy; spinal muscular atrophy; rehabilitation; Exergaming; Pediatrics; Randomized-controlled trial