Spinal Muscular Atrophy
Conditions
Keywords
spinal muscular atrophy, rehabilitation, Exergaming, Pediatrics, Randomized-controlled trial
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).
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
OTHERTales 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
OTHERUsual Care
Continue with regularly accessed physical activities and rehabilitation services
Sponsors
Maryam Oskoui, MD, MSc, FRCPC, FAAN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with occupational performance | Baseline to 16 weeks | Canadian Occupational Performance Measure (COPM) Satisfaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported fatigue | Baseline to 16 weeks | Patient-Reported Outcomes Measurement Information System (PROMIS-SF) |
| Independence performing activities of daily living | Baseline to 16 weeks | SMA Independence Scale (SMAIS) |
| Upper limb motor activity | Baseline to 16 weeks | Median and 99th percentile of upper limb rotational effort and vertical wrist acceleration derived from data captured by the Syde wearable device |
Countries
Canada
Contacts
Primary ContactMbaye Ndiaye
Outcome results
None listed