NCT03531788

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

Use of Dynamic Arm Support Devices for Upper Limb Function in Non-Ambulatory Men With Duchenne Muscular Dystrophy (DMD)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Roxanna Marie Bendixen · Academic / Other
• Sex: Male
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Armon Ayura (Kinova)	Actively assisted mechanical arm support (electric powered to balance arm)
DEVICE	JAECO Wrex	Passive mechanical arm support (elastic bands to balance arm)

Timeline

• Start date: 2018-08-30
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-05-22
• Last updated: 2022-02-18
• Results posted: 2022-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study