Duchenne Muscular DystrophyNCT03531788
Use of Dynamic Arm Supports to Promote Activities of Daily Living in Individuals With DMD
A study testing Armon Ayura (Kinova) and JAECO Wrex in people with Duchenne Muscular Dystrophy, run by Roxanna Marie Bendixen at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Armon Ayura (Kinova) and JAECO Wrex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: 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.
Read the 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.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Armon Ayura (Kinova), JAECO Wrex
- Keywords
- dynamic arm support, mobile arm support, rehabilitation, occupational therapy
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armon Ayura (Kinova)Device
Also called Kinova
Actively assisted mechanical arm support (electric powered to balance arm)
JAECO WrexDevice
Passive mechanical arm support (elastic bands to balance arm)
| Study group | Role | What they receive |
|---|---|---|
| Armon Ayura (Kinova) | Experimental | Participants will trial the Armon Ayura dynamic arm support. Receives: Device: Armon Ayura (Kinova) |
| JAECO WREX | Experimental | Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support. Receives: Device: JAECO Wrex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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).
Measured: The GAS is completed and scored at baseline and at the end of the 4 week trial with and without the device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start30 Aug 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: COVID inhibited additional home visits for device installation and testing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to trial a dynamic arm support (Armon Ayura (Kinova) or JAECO WREX)
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxanna Marie Bendixen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roxanna Marie Bendixen, University of Pittsburgh
- Investigators
- Roxanna M Bendixen, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531788
- Sponsor's protocol ID
- PRO18010005
- Status last verified
- Jan 2022
- First submitted
- 2 Apr 2018
- Last updated
- 18 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dynamic Arm Support Devices for Upper Limb Function in Non-Ambulatory Men With Duchenne Muscular Dystrophy (DMD)
- ClinicalTrials.gov ID
- NCT03531788
- Acronym / sponsor ID
- PRO18010005
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- dynamic arm support, mobile arm support, rehabilitation, occupational therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID inhibited additional home visits for device installation and testing
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Roxanna Marie BendixenUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Posted 18 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to trial a dynamic arm support (Armon Ayura (Kinova) or JAECO WREX)
| Arm | Type | Receives |
|---|---|---|
| Armon Ayura (Kinova) | Experimental | Device: Armon Ayura (Kinova)Participants will trial the Armon Ayura dynamic arm support. |
| JAECO WREX | Experimental | Device: JAECO WrexParticipants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Armon Ayura (Kinova)Also: KinovaActively assisted mechanical arm support (electric powered to balance arm) | Device | Armon Ayura (Kinova) |
| JAECO WrexPassive mechanical arm support (elastic bands to balance arm) | Device | JAECO WREX |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roxanna M Bendixen, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Armon Ayura (Kinova) and JAECO Wrex in people with Duchenne Muscular Dystrophy, run by Roxanna Marie Bendixen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.