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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Satisfaction with occupational performance
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Exergaming Intervention for 8 Weeks
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
干预措施: Tales from the Magic Keep™ (Other)
Usual Care for 8 weeks.
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
干预措施: Usual Care (Other)
结局指标
主要结局
Satisfaction with occupational performance
时间窗: Baseline to 16 weeks
Canadian Occupational Performance Measure (COPM) Satisfaction
次要结局
- Independence performing activities of daily living(Baseline to 16 weeks)
- Upper limb motor activity(Baseline to 16 weeks)
- Self-reported fatigue(Baseline to 16 weeks)
- Independence performing activities of daily living(Baseline to 16 weeks)
- Upper limb motor activity(Baseline to 16 weeks)
研究者
Maryam Oskoui, MD, MSc, FRCPC, FAAN
Full Professor, Department of Pediatrics and Neurology & Neurosurgery
McGill University Health Centre/Research Institute of the McGill University Health Centre