NCT06396325

A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Maryam Oskoui, MD, MSc, FRCPC, FAAN · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Spinal Muscular Atrophy

Interventions

Type	Name	Description
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
OTHER	Usual Care	Continue with regularly accessed physical activities and rehabilitation services

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-05-02
• Last updated: 2025-07-08

Locations

5 sites across 1 country: Canada