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

ConditionSpinal Muscular Atrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorMaryam Oskoui, MD, MSc, FRCPC, FAAN

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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")

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tales from the Magic Keep™

    Other intervention

    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 Care

    Other intervention

    Continue with regularly accessed physical activities and rehabilitation services

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Exergaming Intervention for 8 WeeksExperimental treatment 1 intervention
Group B: Usual Care for 8 weeks.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Satisfaction with occupational performance

Canadian Occupational Performance Measure (COPM) Satisfaction

Time frame
Baseline to 16 weeks

Secondary outcomes

1

Self-reported fatigue

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

Time frame
Baseline to 16 weeks
2

Independence performing activities of daily living

SMA Independence Scale (SMAIS)

Time frame
Baseline to 16 weeks
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maryam Oskoui, MD, MSc, FRCPC, FAAN

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor institution

Source ClinicalTrials.gov
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