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 : Active, not recruiting
First Posted : May 22, 2018
Last Update Posted : February 5, 2020
|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 :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531788
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15260|
|Principal Investigator:||Roxanna M Bendixen, PhD||University of Pittsburgh|