A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tales from the Magic Keep™, Usual Care.
- Who it may be relevant to
- Registry conditions: Spinal Muscular Atrophy. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Satisfaction with occupational performance [Time frame: Baseline to 16 weeks]
Secondary outcome measures (3)
- Self-reported fatigue [Time frame: Baseline to 16 weeks]
- Independence performing activities of daily living [Time frame: Baseline to 16 weeks]
- Upper limb motor activity [Time frame: Baseline to 16 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Canada · 5 centers
- Alberta Children's Hospital — Calgary
- BC Children's Hospital — Vancouver
- IWK Health Services — Halifax
- Hospital for SickKids — Toronto
- Centre de readaptation Marie-Enfant — Montreal
Identifiers
NCT: NCT06396325 · MP-37-2022-7289