Recruiting

Exergaming Intervention

Sponsor:

Maryam Oskoui, MD, MSc, FRCPC, FAAN

Code:

NCT06396325

Conditions

Spinal Muscular Atrophy

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Tales from the Magic Keep™

Usual Care

Study Details

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).

Conditions

Spinal Muscular Atrophy

Study ID

NCT06396325

Start date

Nov 1, 2024

Status verified date

Jul, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exergaming Intervention for 8 Weeks

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

active comparator: Usual Care for 8 weeks.

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

Interventions

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

Usual Care

Continue with regularly accessed physical activities and rehabilitation services

Primary outcome measure

  • Satisfaction with occupational performance [ Time Frame: Baseline to 16 weeks ]

Central Contacts and Locations

Central contacts

Mbaye Ndiaye

5149341934mbaye.ndiaye@muhc.mcgill.ca

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada

Contacts

Julie Dao

403-955-7211Julie.dao@ucalgary.ca

Principal Investigator:

Jean Mah

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

Alex Salvarinov

604 875 2345alex.salvarinov@cw.bc.ca

Principal Investigator:

Kathryn Selby

IWK Health Services

Recruiting

Halifax, Nova Scotia, Canada

Contacts

Sara Drisdelle

902-789-1599sara.drisdelle@iwk.nshealth.ca

Principal Investigator:

Jordan Sheriko

Hospital for SickKids

Recruiting

Toronto, Ontario, Canada

Contacts

Ana Stosic

416-813-7654ana.stosic@sickkids.ca

Principal Investigator:

Hernan Gonorazky

Centre de readaptation Marie-Enfant

Recruiting

Montreal, Quebec, Canada

Contacts

Evemie Dube

514 374-1710evemie.dube.hsj@ssss.gouv.qc.ca

Principal Investigator:

Danielle Levac

More Information

Sponsor

Maryam Oskoui, MD, MSc, FRCPC, FAAN

Last update posted

Jul 8, 2025

Last verified

Jul, 2025

Keywords

  • spinal muscular atrophy
  • rehabilitation
  • Exergaming
  • Pediatrics
  • Randomized-controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maryam Oskoui, MD, MSc, FRCPC, FAAN on 2025-07-08.