Home-based exergaming for children with spinal muscular atrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mbaye.ndiaye@muhc.mcgill.ca
• Phone: 5149341934

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pregnancy-time treatment of fetal SMA: a registry of mother-child outcomes

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  Recruiting at 6 sites Phase 4 Novartis · Little Rock, Arkansas and 5 other locations · NCT07448610

• Salanersen (BIIB115) for improving movement in people 15–60 with spinal muscular atrophy who are treatment‑naïve or previously on risdiplam

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• CuidAME: Spain's longitudinal registry for spinal muscular atrophy

  This project collects long-term clinical and treatment data from children and adults with genetically confirmed 5q spinal muscular atrophy in Spain to track outcomes over time.

  Recruiting Fundació Sant Joan de Déu · Esplugues de Llobregat · NCT07231549

• Apitegromab for infants under 2 with spinal muscular atrophy

  This trial will test whether adding apitegromab to approved SMA therapy helps infants under 2 with 5q SMA reach better motor milestones.

  Recruiting at 23 sites Phase 2 Scholar Rock, Inc. · Phoenix, Arizona and 22 other locations · NCT07047144

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.