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

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

key information

study id #: NCT03531788

condition: Duchenne Muscular Dystrophy

status: recruiting

purpose:

This study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (Armon Ayura-Kinova and JAECO WREX) to promote participation in activities of daily living in non-ambulatory individuals with Duchenne muscular dystrophy (DMD) with upper extremity weakness.

intervention: Armon Ayura, JAECO Wrex

mechanism of action: No pharmaceutical intervention

results: https://clinicaltrials.gov/ct2/show/results/NCT03531788

last updated: June 10, 2019

study details

start date: August 30, 2018

estimated completion: October 31, 2019

phase of development: N/A

size / enrollment: 30

study description:
This study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (Armon Ayura-Kinova and JAECO WREX) to promote participation in activities of daily living 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, 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 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.

primary outcomes:

  • Change in Upper Extremity Acceleration through Actigraphy [ Time Frame: Activity monitoring occurs throughout the trial period from baseline to 8 weeks ]
    Measured through the ActiGraph GT9X wrist worn activity monitoring device - The multi-axis accelerometer measures acceleration normalized to Earth gravity (g) in the x, y, and z axis.
  • Change in Upper Extremity Position through Actigraphy [ Time Frame: Activity monitoring occurs throughout the trial period from baseline to 8 weeks ]
    Measured through the ActiGraph GT9X wrist worn activity monitoring device - The multi-axis gyroscope measures angular rates in degrees per second in the x, y, and z axis.

secondary outcomes:

  • Goal Attainment Scale (GAS) [ Time Frame: The GAS will be completed and scored at baseline, then scored again at 6 weeks ]
    The GAS is a personal interview which allows the individual to determine important and personally meaningful goals. 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.

inclusion criteria:
• 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 UE Scale
• Self-report of needs assistance/unable to achieve independently on at least 10 items on the 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)

exclusion criteria:
• 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)

study contacts

sponsor: Roxanna Marie Bendixen

contacts: Roxanna M Bendixen PhD, 412-383-5045, bendixen@pitt.edu

investigators: Roxanna M Bendixen, PhD

locations: United States