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

NCT03531788 | Terminated Results FDA Device

• 1 other identifier: PRO18010005
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Duchenne Muscular Dystrophy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Upper Extremity Activity Counts (Movement) Through Actigraphy

  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.

  Collection of activity counts through the ActiGraph GT9x occurred during testing phase with and without the upper extremity arm device.

• Change in Upper Extremity Position Through Actigraphy

  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.

  Collection of activity counts through the ActiGraph GT9x occurs from baseline through the end of the 4-week device trial.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Armon Ayura (Kinova)

EXPERIMENTAL

Participants will trial the Armon Ayura dynamic arm support.

Device: Armon Ayura (Kinova)

JAECO WREX

EXPERIMENTAL

Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.

Device: JAECO Wrex

Interventions

Armon Ayura (Kinova) DEVICE

Actively assisted mechanical arm support (electric powered to balance arm)

Also known as: Kinova

Armon Ayura (Kinova)

JAECO Wrex DEVICE

Passive mechanical arm support (elastic bands to balance arm)

JAECO WREX

Eligibility Criteria

• Age: 14 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Roxanna Marie Bendixen: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Coronavirus disease 2019 (COVID) occurred during recruitment and testing, which required us to terminate the trial early before achieving full recruitment. Technical problems with the accelerometer (Actigraph GT9x) led to missing data. At times testing occurred when the participant was not wearing the accelerometer, also leading to missing data. Sample sizes were therefore too small to compute p values or provide any comparative data (between devices). Therefore, change scores were recorded.

Results Point of Contact

• Title: Roxanna M. Bendixen, Principal Investigator
• Organization: University of Pittsburgh

bendixen@pitt.edu

4123836603

Study Officials

• Roxanna M Bendixen, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to trial a dynamic arm support (Armon Ayura (Kinova) or JAECO WREX)

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: May 22, 2018
• Study Start: August 30, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 18, 2022
• Results First Posted: February 18, 2022

Record last verified: 2022-01

Locations

US (1)