Clinical trial NCT03531788: Use of Dynamic Arm Supports to Promote Activities of Daily Living in Individuals With DMD
Official title: Use of Dynamic Arm Support Devices for Upper Limb Function in Non-Ambulatory Men With Duchenne Muscular Dystrophy (DMD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Keywords: dynamic arm support
mobile arm support
rehabilitation
occupational therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 18
Sex: MALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to trial a dynamic arm support (Armon Ayura (Kinova) or JAECO WREX)
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Upper Extremity Activity Counts (Movement) Through Actigraphy
timeFrame: Collection of activity counts through the ActiGraph GT9x occurred during testing phase with and without the upper extremity arm device.
measure: Change in Upper Extremity Position Through Actigraphy
timeFrame: Collection of activity counts through the ActiGraph GT9x occurs from baseline through the end of the 4-week device trial.
Secondary outcomes:
measure: Goal Attainment Scale (GAS)
timeFrame: The GAS is completed and scored at baseline and at the end of the 4 week trial with and without the device.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Roxanna M Bendixen, PhD
role: PRINCIPAL_INVESTIGATOR
References: