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Behavioural Intervention

Exergaming for Spinal Muscular Atrophy (INFORM SMA Trial)

N/A

Recruiting

Led By Danielle Levac

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed genetic diagnosis of 5q SMA

Participant is able to stay seated independently without support for at least 10 seconds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if playing video games at home for 8 weeks can help children and youth with spinal muscular atrophy feel more satisfied with their daily activities compared to their usual care.

Who is the study for?

This trial is for children and adolescents aged 8-18 with spinal muscular atrophy (SMA) who can raise their hands to their mouth but not a light weight, are on disease-modifying therapy, have confirmed genetic SMA diagnosis, and can sit unaided for at least 10 seconds.

What is being tested?

The study compares an 8-week home-based exergaming program called Tales from the Magic Keep™ against usual care. It aims to see if this fun video game-like exercise can improve how satisfied kids with SMA feel about their daily activities.

What are the potential side effects?

Since the intervention involves playing an exergame designed for children with SMA, side effects might include typical exercise-related issues like muscle soreness or fatigue. However, specific side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed genetic diagnosis of 5q SMA.

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I can sit by myself without support for at least 10 seconds.

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I can move my hands to my mouth but can't lift a light weight to it.

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I am between 8 and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Satisfaction with occupational performance

Secondary study objectives

Independence performing activities of daily living

Self- reported fatigue

Upper limb motor activity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exergaming Intervention for 8 WeeksExperimental Treatment1 Intervention

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

Group II: Usual Care for 8 weeks.Active Control1 Intervention

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

0 / 4Eligibility criteria met