NCT03531788

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

Terminated NA Results posted Last updated 18 February 2022

What this trial tests

NA trial testing Armon Ayura (Kinova) in Duchenne Muscular Dystrophy in 18 participants. Terminated before completion.

Timeline

30 August 2018

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Roxanna Marie Bendixen
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	30 August 2018
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Armon Ayura (Kinova)
• JAECO Wrex

Conditions studied

• Duchenne Muscular Dystrophy — all drugs for Duchenne Muscular Dystrophy →

Sponsor

Roxanna Marie Bendixen

Who can join

14 and older, male only, with Duchenne Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Upper Extremity Activity Counts (Movement) Through Actigraphy Primary · 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.

Group	Value	95% CI
Armon Ayura (Kinova)	270.61	± 375.50
JAECO WREX	26.75	± 123.04

Change in Upper Extremity Position Through Actigraphy Primary · 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.

Average x axis change score

Group	Value	95% CI
Armon Ayura (Kinova)	19838.12	± 41880.09
JAECO WREX	44697.80	± 89132.49

Average y axis change score

Group	Value	95% CI
Armon Ayura (Kinova)	69125.26	± 102942.92
JAECO WREX	1279.76	± 141962.15

Average z axis change score

Group	Value	95% CI
Armon Ayura (Kinova)	59784.84	± 91039.70
JAECO WREX	17297.11	± 130688.29

Goal Attainment Scale (GAS) Secondary · 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

Goal 1

Group	Value	95% CI
Armon Ayura (Kinova)	3.09	± 0.83
JAECO WREX	3.5	± 1.0

Goal 2

Group	Value	95% CI
Armon Ayura (Kinova)	2.72	± 1.9
JAECO WREX	2.75	± 1.9

Goal 3

Group	Value	95% CI
Armon Ayura (Kinova)	3.18	± 0.87
JAECO WREX	3.5	± 0.58

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions for promoting physical activity in people with neuromuscular disease.
   Jones K, Hawke F, Newman J, Miller JA, et al · · 2021 · cited 16× · PMID 34027632 · DOI 10.1002/14651858.cd013544.pub2