Use of Dynamic Arm Supports to Promote Activities of Daily Living in Individuals With DMD

Not Applicable

Terminated

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Exclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Armon Ayura (Kinova)	Armon Ayura (Kinova)	Participants will trial the Armon Ayura dynamic arm support.
JAECO WREX	JAECO Wrex	Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.

Primary Outcome Measures

Name	Time	Method
Change in Upper Extremity Activity Counts (Movement) Through Actigraphy	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	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.

Secondary Outcome Measures

Name	Time	Method
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.	The GAS is a personal interview which allows the individual to determine important and personally meaningful goals. Each participant chose three individualized goals to work on and assess at the end of the study. Goal scaling is standardized in order to calculate the extent to which a patient's goals are met.The GAS uses a 5-point rating scale to determine if the goal was not met (-2) up to a greater than expected meeting of the personal goal (+2). A score of 0 indicates the goal was met as anticipated. We report the average change in the score of each goal when the participant uses the trial device. Here we use change scores which range from 0 (performed the same with and without the device) to 4 (participant performed at a greater than expected level with the device).