Use of Dynamic Arm Support Devices for Upper Limb Function in Non-Ambulatory Men With Duchenne Muscular Dystrophy (DMD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Upper Extremity Activity Counts (Movement) Through Actigraphy
研究概览
简要总结
This study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (1) Armon Ayura-Kinova and 2) JAECO WREX) to promote participation in activities of daily living (ADLs) in non-ambulatory individuals with Duchenne muscular dystrophy (DMD) with upper extremity weakness.
详细描述
This study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (1) Armon Ayura-Kinova and 2) JAECO WREX) to promote participation in activities of daily living (ADLs) in non-ambulatory individuals with Duchenne muscular dystrophy (DMD) with upper extremity weakness. Up to 30 individuals will be enrolled to participate in this research study, which includes a two-week baseline data collection period, a four-week device trial and a two-week post device data collection period. Participants will be randomly assigned to trial one of the dynamic arm support devices during the four week in-home trial. The ActiGraph GT9x (name of device), a wrist worn activity monitoring device, will be worn during the baseline period, the device trial and the post device data collection period to capture upper extremity (UE) movement patterns. UE performance will be further quantified with use of a physical motor assessment, the Performance of Upper Limb (PUL) assessment and patient reported outcomes. Data gleaned will provide important knowledge and objective results regarding the potential benefit of dynamic arm supports in individuals with DMD with limited functional use of their upper extremities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •14 years of age or older
- •Self-report diagnosis of Duchenne muscular dystrophy (DMD)
- •Use a wheelchair for mobility
- •Score 3-5 on the Brooke Upper Extremity (UE) Scale
- •Self-report of needs assistance/unable to achieve independently on at least 10 items on the Upper Limb Activities of Daily Living (UL ADL) self-report questionnaire
- •Able to follow instructions
- •Informed consent provided by self (18 and over) or by parent or legal guardian (if under the age of 18)
排除标准
- •Does not have minimum level of UE function to operate the assigned dynamic arm support (Score of 6 on the Brooke UE scale or any other impairment limiting use)
- •The assigned dynamic arm support is unable to be mounted to wheelchair (mounts will vary based on manufacturer/model of wheelchair)
结局指标
主要结局
Change in Upper Extremity Activity Counts (Movement) Through Actigraphy
时间窗: Collection of activity counts through the ActiGraph GT9x occurred during testing phase with and without the upper extremity arm device.
Measured through the ActiGraph GT9X wrist worn activity monitoring device: The multi-axis activity monitor measures activity counts that represent movement of the upper extremity. We calculated the average activity counts during testing items with the arm device and testing items without the arm device. We then calculated change scores (average activity counts without the device minus average activity counts with the device). Higher activity counts indicate more effort and more movement during item testing without the device compared to using the device.
Change in Upper Extremity Position Through Actigraphy
时间窗: Collection of activity counts through the ActiGraph GT9x occurs from baseline through the end of the 4-week device trial.
Measured through the ActiGraph GT9X wrist worn activity monitoring device: The multi-axis activity monitor (gyroscope within the monitor) measures activity counts (movement) per second in the x, y, and z planes. Change in average activity counts (movement) in x, y, and z planes during the 4-week trial period compared to the 2-week baseline period are reported (higher activity counts means more movement during trial). X plane is horizontal movement, y plane is vertical movement, and z plane extends outward from the body.
次要结局
- Goal Attainment Scale (GAS)(The GAS is completed and scored at baseline and at the end of the 4 week trial with and without the device.)
研究者
Roxanna Marie Bendixen
Associate Professor
University of Pittsburgh