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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
Alberta Children's Hospital
RECRUITING
Calgary
IWK Health Services
RECRUITING
Halifax
Centre de readaptation Marie-Enfant
RECRUITING
Montreal
Hospital for SickKids
RECRUITING
Toronto
BC Children's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Mbaye Ndiaye
mbaye.ndiaye@muhc.mcgill.ca
5149341934
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 22
Treatments
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
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
Related Therapeutic Areas
Sponsors
Leads: Maryam Oskoui, MD, MSc, FRCPC, FAAN