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New treatment option for Spinal Muscular Atrophy
Official title A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy
ClinicalTrials.gov ID: NCT06396325
What this study is testing
- What it's testing
- 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).
- Time commitment: about 8 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 18
You may be able to join if
- 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...
- Treated with disease-modifying therapy
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.