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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).
This multisite randomized controlled registry-based trial will evaluate the efficacy of a home-based exergaming intervention, as compared to usual care, on occupational satisfaction of children and youth (aged 8-18 years old) with SMA. Participants in the intervention arm will play the exergame, Tales from the Magic Keepâ„¢ on the Azure Kinect platform, 3 times per week, for at least 20 minutes, over 8 weeks (total 8 hours), and continue to access their regular physical activities and rehabilitation services. Those in the usual care arm will continue to access their regular physical activities and rehabilitation services. Occupational satisfaction will be assessed using the Canadian Occupational Performance Measure (COPM) at 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exergaming Intervention for 8 Weeks | Experimental | 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 |
|
| Usual Care for 8 weeks. | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tales from the Magic Keepâ„¢ | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with occupational performance | Canadian Occupational Performance Measure (COPM) Satisfaction | Baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported fatigue | Patient-Reported Outcomes Measurement Information System (PROMIS-SF) | Baseline to 16 weeks |
| Independence performing activities of daily living | SMA Independence Scale (SMAIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mbaye Ndiaye | Contact | 5149341934 | 37299 | mbaye.ndiaye@muhc.mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Maryam Oskoui | McGill University | Principal Investigator |
| Danielle Levac | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Recruiting | Calgary | Alberta | Canada |
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|
| Usual Care | Other | Continue with regularly accessed physical activities and rehabilitation services |
|
| Baseline to 16 weeks |
| Upper limb motor activity | Median and 99th percentile of upper limb rotational effort and vertical wrist acceleration derived from data captured by the Syde wearable device | Baseline to 16 weeks |
| BC Children's Hospital | Recruiting | Vancouver | British Columbia | Canada |
|
| IWK Health Services | Recruiting | Halifax | Nova Scotia | Canada |
|
| Hospital for SickKids | Recruiting | Toronto | Ontario | Canada |
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| Centre de readaptation Marie-Enfant | Recruiting | Montreal | Quebec | Canada |
|
| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D009468 | Neuromuscular Diseases |
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