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

Maryam Oskoui, MD, MSc, FRCPC, FAAN

Status: Enrolling

Conditions: Spinal Muscular Atrophy

Treatments: Other: Tales from the Magic Keep™; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06396325

MP-37-2022-7289

Details and patient eligibility

About

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).

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Exergaming Intervention for 8 Weeks

Experimental group

Description:

Extension Phase: Participants randomized ot the intervention arm will play Tales from the Magic Keep at home for the 8 week open-label extension phase

Treatment:

Other: Tales from the Magic Keep™

Usual Care for 8 weeks.

Active Comparator group

Description:

Extension Phase: Participants randomized to waitlist usual care will play Tales from the Magic Keep at home for the 8 week open-label extension phase

Treatment:

Other: Usual Care