NCT06396325 A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy
| NCT ID | NCT06396325 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maryam Oskoui, MD, MSc, FRCPC, FAAN |
| Condition | Spinal Muscular Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 22 participants in total. It began in 2024-11-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Maryam Oskoui
PRINCIPAL INVESTIGATOR
McGill University
Frequently Asked Questions
Who can join the NCT06396325 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Spinal Muscular Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06396325 currently recruiting?
Yes, NCT06396325 is actively recruiting participants. Contact the research team at mbaye.ndiaye@muhc.mcgill.ca for enrollment information.
Where is the NCT06396325 trial being conducted?
This trial is being conducted at Calgary, Canada, Vancouver, Canada, Halifax, Canada, Toronto, Canada and 1 additional location.
Who is sponsoring the NCT06396325 clinical trial?
NCT06396325 is sponsored by Maryam Oskoui, MD, MSc, FRCPC, FAAN. The principal investigator is Maryam Oskoui at McGill University. The trial plans to enroll 22 participants.