A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy
NCT ID: NCT06396325
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
22 participants
INTERVENTIONAL
2024-11-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Immersive Virtual Environments and Wearable Haptic Devices in Rehabilitation of Children With Neuromotor Impairments
NCT03353623
Bootle Blast: Pilot Randomized Controlled Trial
NCT07289360
Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy
NCT03223051
Outpatient Rehabilitation Intervention for Young Children With SMA
NCT05638750
Comparison of Structured Exercise and Exergaming in Pediatric-Onset Multiple Sclerosis
NCT07257900
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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 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
Usual Care
Continue with regularly accessed physical activities and rehabilitation services
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
8 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maryam Oskoui, MD, MSc, FRCPC, FAAN
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maryam Oskoui, MD, MSc, FRCPC, FAAN
Full Professor, Department of Pediatrics and Neurology & Neurosurgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maryam Oskoui
Role: PRINCIPAL_INVESTIGATOR
McGill University
Danielle Levac
Role: PRINCIPAL_INVESTIGATOR
Université de Montréal
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alberta Children's Hospital
Calgary, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
IWK Health Services
Halifax, Nova Scotia, Canada
Hospital for SickKids
Toronto, Ontario, Canada
Centre de readaptation Marie-Enfant
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MP-37-2022-7289
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.