- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531788
Use of Dynamic Arm Supports to Promote Activities of Daily Living in Individuals With DMD
January 27, 2022 updated by: Roxanna Marie Bendixen
Use of Dynamic Arm Support Devices for Upper Limb Function in Non-Ambulatory Men With Duchenne Muscular Dystrophy (DMD)
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15260
- University of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 14 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)
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Armon Ayura (Kinova)
Participants will trial the Armon Ayura dynamic arm support.
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Actively assisted mechanical arm support (electric powered to balance arm)
Other Names:
|
Experimental: JAECO WREX
Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.
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Passive mechanical arm support (elastic bands to balance arm)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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Collection of activity counts through the ActiGraph GT9x occurred during testing phase with and without the upper extremity arm device.
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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.
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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.
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Collection of activity counts through the ActiGraph GT9x occurs from baseline through the end of the 4-week device trial.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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).
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The GAS is completed and scored at baseline and at the end of the 4 week trial with and without the device.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roxanna M Bendixen, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2018
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
April 2, 2018
First Submitted That Met QC Criteria
May 8, 2018
First Posted (Actual)
May 22, 2018
Study Record Updates
Last Update Posted (Actual)
February 18, 2022
Last Update Submitted That Met QC Criteria
January 27, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO18010005
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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