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

Maryam Oskoui, MD, MSc, FRCPC, FAAN22 enrolled

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Spinal Muscular Atrophy

Interventions

Tales from the Magic Keep™OTHER

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

Usual CareOTHER

Continue with regularly accessed physical activities and rehabilitation services

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Alberta Children's Hospital

Calgary, Alberta, Canada

RECRUITING

BC Children's Hospital

Vancouver, British Columbia, Canada

RECRUITING

IWK Health Services

Halifax, Nova Scotia, Canada

RECRUITING

Outcomes

Primary Outcomes

Satisfaction with occupational performance

Canadian Occupational Performance Measure (COPM) Satisfaction

Time frame: Baseline to 16 weeks

Secondary Outcomes

Self-reported fatigue

Patient-Reported Outcomes Measurement Information System (PROMIS-SF)

Time frame: Baseline to 16 weeks

Independence performing activities of daily living

SMA Independence Scale (SMAIS)

Time frame: Baseline to 16 weeks

Upper limb motor activity

Median and 99th percentile of upper limb rotational effort and vertical wrist acceleration derived from data captured by the Syde wearable device

Time frame: Baseline to 16 weeks

Central Contacts

Mbaye Ndiaye

CONTACT

5149341934 mbaye.ndiaye@muhc.mcgill.ca

Data from ClinicalTrials.gov

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