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

Roxanna Marie Bendixen

Status: Terminated

Conditions: Duchenne Muscular Dystrophy

Treatments: Device: Armon Ayura (Kinova); Device: JAECO Wrex

Study type: Interventional

Funder types: Other

Identifiers

NCT03531788

PRO18010005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 14 years of age or older
2. Self-report diagnosis of Duchenne muscular dystrophy (DMD)
3. Use a wheelchair for mobility
4. Score 3-5 on the Brooke Upper Extremity (UE) Scale
5. 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
6. Able to follow instructions
7. Informed consent provided by self (18 and over) or by parent or legal guardian (if under the age of 18)

Exclusion criteria

1. 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)
2. The assigned dynamic arm support is unable to be mounted to wheelchair (mounts will vary based on manufacturer/model of wheelchair)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Armon Ayura (Kinova)

Experimental group

Description:

Participants will trial the Armon Ayura dynamic arm support.

Treatment:

Device: Armon Ayura (Kinova)

JAECO WREX

Experimental group

Description:

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

Treatment:

Device: JAECO Wrex