Duchenne Muscular Dystrophy
Conditions
Keywords
dynamic arm support, mobile arm support, rehabilitation, occupational therapy
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.
Interventions
DEVICEArmon Ayura (Kinova)
Actively assisted mechanical arm support (electric powered to balance arm)
DEVICEJAECO Wrex
Passive mechanical arm support (elastic bands to balance arm)
Sponsors
Roxanna Marie Bendixen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned to trial a dynamic arm support (Armon Ayura (Kinova) or JAECO WREX)
Eligibility
Sex/Gender
MALE
Age
14 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Activity Counts (Movement) Through Actigraphy | 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. |
| Change in Upper Extremity Position Through Actigraphy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goal Attainment Scale (GAS) | 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 device. Here we use change scores which range from 0 (performed the same with and without the device) to 4 (participant performed at a greater than expected level with the device). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Armon Ayura (Kinova) Participants will trial the Armon Ayura dynamic arm support.
Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm) | 12 |
| JAECO WREX Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.
JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm) | 6 |
| Total | 18 |
Baseline characteristics
| Characteristic | Armon Ayura (Kinova) | JAECO WREX | Total |
|---|---|---|---|
| Actigraphy (wrist worn activity monitor) | 534.02 activity counts STANDARD_DEVIATION 321.35 | 235.80 activity counts STANDARD_DEVIATION 150.51 | 444.55 activity counts STANDARD_DEVIATION 307.62 |
| Age, Categorical <=18 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 2 Participants | 8 Participants |
| Age, Continuous | 18.10 years STANDARD_DEVIATION 2.32 | 18.22 years STANDARD_DEVIATION 4.2 | 18.16 years STANDARD_DEVIATION 3.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 6 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 6 Participants | 17 Participants |
| Region of Enrollment United States | 12 participants | 6 participants | 18 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 6 |
| other Total, other adverse events | 0 / 12 | 0 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 |
Outcome results
Primary
Change in Upper Extremity Activity Counts (Movement) Through Actigraphy
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.
Time frame: Collection of activity counts through the ActiGraph GT9x occurred during testing phase with and without the upper extremity arm device.
Population: All participants who had completed the testing period while wearing the Actigraph GT9x are reported. All participants were tested, but data are missing due to technology failure or not wearing the ActiGraph during testing. Participants who were not wearing the ActiGraph during testing are not reported. Comparisons between groups (Kinova and WREX) were not analyzed due to small sample sizes in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armon Ayura (Kinova) | Change in Upper Extremity Activity Counts (Movement) Through Actigraphy | 270.61 Activity Counts | Standard Deviation 375.5 |
| JAECO WREX | Change in Upper Extremity Activity Counts (Movement) Through Actigraphy | 26.75 Activity Counts | Standard Deviation 123.04 |
Comparison: Activity counts from the ActiGraph GT9x activity monitor provide data per participant during testing of upper extremity activities/tasks and were collected while wearing the device (Kinova and WREX) and without the device (Kinova and WREX). For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.
Primary
Change in Upper Extremity Position Through Actigraphy
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.
Time frame: Collection of activity counts through the ActiGraph GT9x occurs from baseline through the end of the 4-week device trial.
Population: All participants who completed the testing period while wearing the Actigraph are reported. Comparisons between groups (Kinova and WREX) were not analyzed due to small sample sizes in both groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armon Ayura (Kinova) | Change in Upper Extremity Position Through Actigraphy | Average x axis change score | 19838.12 Activity Counts | Standard Deviation 41880.09 |
| Armon Ayura (Kinova) | Change in Upper Extremity Position Through Actigraphy | Average y axis change score | 69125.26 Activity Counts | Standard Deviation 102942.92 |
| Armon Ayura (Kinova) | Change in Upper Extremity Position Through Actigraphy | Average z axis change score | 59784.84 Activity Counts | Standard Deviation 91039.7 |
| JAECO WREX | Change in Upper Extremity Position Through Actigraphy | Average x axis change score | 44697.80 Activity Counts | Standard Deviation 89132.49 |
| JAECO WREX | Change in Upper Extremity Position Through Actigraphy | Average y axis change score | 1279.76 Activity Counts | Standard Deviation 141962.15 |
| JAECO WREX | Change in Upper Extremity Position Through Actigraphy | Average z axis change score | 17297.11 Activity Counts | Standard Deviation 130688.29 |
Comparison: Activity counts from the ActiGraph GT9x activity monitor were collected during baseline (without a device) and throughout the 4 week device trial (with the device). For each time period, activity count data were averaged across the day. We then compared the baseline time period to the device trial period to understand the difference in movement and upper extremity positioning during the device trial. Data presented are within group change scores and not between group data comparisons.
Secondary
Goal Attainment Scale (GAS)
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 device. Here we use change scores which range from 0 (performed the same with and without the device) to 4 (participant performed at a greater than expected level with the device).
Time frame: The GAS is completed and scored at baseline and at the end of the 4 week trial with and without the device.
Population: Participants were included in this analysis if they completed the Goal Attainment Scale (GAS) with and without the use of the arm device (Kinova or WREX). Sample sizes were too small to use statistical analyses for comparisons between groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Armon Ayura (Kinova) | Goal Attainment Scale (GAS) | Goal 1 | 3.09 score on a scale | Standard Deviation 0.83 |
| Armon Ayura (Kinova) | Goal Attainment Scale (GAS) | Goal 2 | 2.72 score on a scale | Standard Deviation 1.9 |
| Armon Ayura (Kinova) | Goal Attainment Scale (GAS) | Goal 3 | 3.18 score on a scale | Standard Deviation 0.87 |
| JAECO WREX | Goal Attainment Scale (GAS) | Goal 1 | 3.5 score on a scale | Standard Deviation 1 |
| JAECO WREX | Goal Attainment Scale (GAS) | Goal 2 | 2.75 score on a scale | Standard Deviation 1.9 |
| JAECO WREX | Goal Attainment Scale (GAS) | Goal 3 | 3.5 score on a scale | Standard Deviation 0.58 |
Comparison: Three goals were identified for each participant and scored without using an arm support device to serve as a baseline measure of abilities. These scores were compared to the scores achieved on the same goals using the arm support device.