Use of Dynamic Arm Supports to Promote Activities of Daily Living in Individuals With DMD
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|ClinicalTrials.gov Identifier: NCT03531788|
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Duchenne Muscular Dystrophy||Device: Armon Ayura (Kinova) Device: JAECO Wrex||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomly assigned to trial a dynamic arm support (Armon Ayura (Kinova) or JAECO WREX)|
|Masking:||None (Open Label)|
|Official Title:||Use of Dynamic Arm Support Devices for Upper Limb Function in Non-Ambulatory Men With Duchenne Muscular Dystrophy (DMD)|
|Actual Study Start Date :||August 30, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Armon Ayura (Kinova)
Participants will trial the Armon Ayura dynamic arm support.
Device: Armon Ayura (Kinova)
Actively assisted mechanical arm support (electric powered to balance arm)
Other Name: Kinova
Experimental: JAECO WREX
Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.
Device: JAECO Wrex
Passive mechanical arm support (elastic bands to balance arm)
- Change in Upper Extremity Acceleration through Actigraphy [ Time Frame: Activity monitoring occurs throughout the trial period from baseline to 8 weeks ]Measured through the ActiGraph GT9X wrist worn activity monitoring device - The multi-axis accelerometer measures acceleration normalized to Earth gravity (g) in the x, y, and z axis.
- Change in Upper Extremity Position through Actigraphy [ Time Frame: Activity monitoring occurs throughout the trial period from baseline to 8 weeks ]Measured through the ActiGraph GT9X wrist worn activity monitoring device - The multi-axis gyroscope measures angular rates in degrees per second in the x, y, and z axis.
- Goal Attainment Scale (GAS) [ Time Frame: The GAS will be completed and scored at baseline, then scored again at 6 weeks ]The GAS is a personal interview which allows the individual to determine important and personally meaningful goals. 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531788
|Contact: Roxanna M Bendixen, PhDfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15260|
|Contact: Annmarie Kelleher, MS 412-383-5045|
|Principal Investigator:||Roxanna M Bendixen, PhD||University of Pittsburgh|