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

Официальное название

A Registry-Based Parallel Group Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy, With an Optional Open-Label Extension

Обзор

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).

Подробное описание

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 Keep™ 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.

Вмешательства

• Другое 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
• Другое Usual Care
  Continue with regularly accessed physical activities and rehabilitation services

Первичные конечные точки

• Satisfaction with occupational performance [Срок оценки: Baseline to 16 weeks]

Вторичные конечные точки (3)

• Self-reported fatigue [Срок оценки: Baseline to 16 weeks]
• Independence performing activities of daily living [Срок оценки: Baseline to 16 weeks]
• Upper limb motor activity [Срок оценки: Baseline to 16 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 5 центров

• Alberta Children's Hospital — Calgary
• BC Children's Hospital — Vancouver
• IWK Health Services — Halifax
• Hospital for SickKids — Toronto
• Centre de readaptation Marie-Enfant — Montreal

Идентификаторы

NCT: NCT06396325 · MP-37-2022-7289

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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