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

• ClinicalTrials.gov Identifier: NCT03531788
• Recruitment Status: Terminated
• First Posted: May 22, 2018
• Results First Posted: February 18, 2022
• Last Update Posted: February 18, 2022
• Sponsor: Roxanna Marie Bendixen
• Information provided by (Responsible Party): Roxanna Marie Bendixen, University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Duchenne Muscular Dystrophy	Device: Armon Ayura (Kinova); Device: JAECO Wrex	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• 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)
• Primary Purpose: Treatment
• 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
• Actual Primary Completion Date: December 31, 2020
• Actual Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. Change in Upper Extremity Activity Counts (Movement) Through Actigraphy [ Time Frame: 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.
2. Change in Upper Extremity Position Through Actigraphy [ Time Frame: 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 :

1. Goal Attainment Scale (GAS) [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 14 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. 14 years of age or older
2. Self-report diagnosis of Duchenne muscular dystrophy (DMD)
3. Use a wheelchair for mobility
4. Score 3-5 on the Brooke Upper Extremity (UE) Scale
5. 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
6. Able to follow instructions
7. Informed consent provided by self (18 and over) or by parent or legal guardian (if under the age of 18)

Exclusion Criteria:

1. 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)
2. The assigned dynamic arm support is unable to be mounted to wheelchair (mounts will vary based on manufacturer/model of wheelchair)

Contacts and Locations

Locations

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15260

Sponsors and Collaborators

Roxanna Marie Bendixen

Investigators

• Principal Investigator: Roxanna M Bendixen, PhD; University of Pittsburgh

  Study Documents (Full-Text)

Documents provided by Roxanna Marie Bendixen, University of Pittsburgh:

Study Protocol and Statistical Analysis Plan  [PDF] March 19, 2020

More Information

• Responsible Party: Roxanna Marie Bendixen, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03531788
• Other Study ID Numbers: PRO18010005
• First Posted: May 22, 2018
• Results First Posted: February 18, 2022
• Last Update Posted: February 18, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Roxanna Marie Bendixen, University of Pittsburgh:

dynamic arm support; mobile arm support; rehabilitation; occupational therapy

Additional relevant MeSH terms:

Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked