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

Launched by MARYAM OSKOUI, MD, MSC, FRCPC, FAAN · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help children and teenagers aged 8 to 18 years with spinal muscular atrophy (SMA) improve their daily activities and enjoyment through an 8-week home-based exergaming program. Exergaming involves fun video games that get players moving and exercising. The goal is to see if this program is better than standard care in helping young people with SMA feel more satisfied with their activities.

To participate, children must have a confirmed genetic diagnosis of SMA, be able to sit up independently for at least 10 seconds, and have already started treatment for their condition. They also need to be able to follow the study rules and read in English or French. If eligible, participants will be randomly assigned to either the exergaming program or usual care, and they will be asked to engage in activities for several weeks. This trial is currently recruiting, so there is an opportunity for interested families to get involved and explore this innovative approach to support their children’s health and well-being.

Gender

ALL

Eligibility criteria

• 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