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

• ClinicalTrials.gov Identifier: NCT03531788
• Recruitment Status: Recruiting
• First Posted: May 22, 2018
• Last Update Posted: June 3, 2019
• 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 (Armon Ayura-Kinova and JAECO WREX) to promote participation in activities of daily living 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 (Armon Ayura-Kinova and JAECO WREX) to promote participation in activities of daily living 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, 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 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)
• Estimated Enrollment: 30 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
• Estimated Primary Completion Date: October 31, 2019
• Estimated Study Completion Date: December 31, 2019

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 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.
2. 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.

Secondary Outcome Measures :

1. 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.

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 UE Scale
5. Self-report of needs assistance/unable to achieve independently on at least 10 items on the 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

Contacts

Contact: Roxanna M Bendixen, PhD; 412-383-5045; bendixen@pitt.edu

Locations

United States, Pennsylvania

University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contact: Annmarie Kelleher, MS 412-383-5045

Sponsors and Collaborators

Roxanna Marie Bendixen

Investigators

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

More Information

• Responsible Party: Roxanna Marie Bendixen, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03531788 History of Changes
• Other Study ID Numbers: 18010005
• First Posted: May 22, 2018
• Last Update Posted: June 3, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No
• 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