Trial Outcomes & Findings for Use of Dynamic Arm Supports to Promote Activities of Daily Living in Individuals With DMD (NCT NCT03531788)
NCT ID: NCT03531788
Last Updated: 2022-02-18
Results Overview
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.
TERMINATED
NA
18 participants
Collection of activity counts through the ActiGraph GT9x occurred during testing phase with and without the upper extremity arm device.
2022-02-18
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
|
Overall Study
COMPLETED
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data were collected using wrist worn Actigraph GT9x during baseline assessment of upper extremity function without the dynamic arm support device. Data were collected over a 2-week time period and means and standard deviation activity counts were used. Actigraph GT9x provides activity counts which measure movement in all directions. The Actigraph was not worn during baseline testing for some participants, resulting in missing activity count data. Higher activity counts represents more movement.
Baseline characteristics by cohort
| Measure |
Armon Ayura (Kinova)
n=12 Participants
Participants will trial the Armon Ayura dynamic arm support.
Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm)
|
JAECO WREX
n=6 Participants
Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.
JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm)
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=12 Participants
|
4 Participants
n=6 Participants
|
10 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=12 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Age, Continuous
|
18.10 years
STANDARD_DEVIATION 2.32 • n=12 Participants
|
18.22 years
STANDARD_DEVIATION 4.20 • n=6 Participants
|
18.16 years
STANDARD_DEVIATION 3.82 • n=18 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=12 Participants
|
6 Participants
n=6 Participants
|
18 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=12 Participants
|
6 Participants
n=6 Participants
|
18 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=12 Participants
|
6 Participants
n=6 Participants
|
17 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
6 participants
n=6 Participants
|
18 participants
n=18 Participants
|
|
Actigraphy (wrist worn activity monitor)
|
534.02 activity counts
STANDARD_DEVIATION 321.35 • n=7 Participants • Data were collected using wrist worn Actigraph GT9x during baseline assessment of upper extremity function without the dynamic arm support device. Data were collected over a 2-week time period and means and standard deviation activity counts were used. Actigraph GT9x provides activity counts which measure movement in all directions. The Actigraph was not worn during baseline testing for some participants, resulting in missing activity count data. Higher activity counts represents more movement.
|
235.80 activity counts
STANDARD_DEVIATION 150.51 • n=3 Participants • Data were collected using wrist worn Actigraph GT9x during baseline assessment of upper extremity function without the dynamic arm support device. Data were collected over a 2-week time period and means and standard deviation activity counts were used. Actigraph GT9x provides activity counts which measure movement in all directions. The Actigraph was not worn during baseline testing for some participants, resulting in missing activity count data. Higher activity counts represents more movement.
|
444.55 activity counts
STANDARD_DEVIATION 307.62 • n=10 Participants • Data were collected using wrist worn Actigraph GT9x during baseline assessment of upper extremity function without the dynamic arm support device. Data were collected over a 2-week time period and means and standard deviation activity counts were used. Actigraph GT9x provides activity counts which measure movement in all directions. The Actigraph was not worn during baseline testing for some participants, resulting in missing activity count data. Higher activity counts represents more movement.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Armon Ayura (Kinova)
n=7 Participants
Participants will trial the Armon Ayura dynamic arm support.
Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm)
|
JAECO WREX
n=3 Participants
Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.
JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm)
|
|---|---|---|
|
Change in Upper Extremity Activity Counts (Movement) Through Actigraphy
|
270.61 Activity Counts
Standard Deviation 375.50
|
26.75 Activity Counts
Standard Deviation 123.04
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Armon Ayura (Kinova)
n=10 Participants
Participants will trial the Armon Ayura dynamic arm support.
Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm)
|
JAECO WREX
n=4 Participants
Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.
JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm)
|
|---|---|---|
|
Change in Upper Extremity Position Through Actigraphy
Average x axis change score
|
19838.12 Activity Counts
Standard Deviation 41880.09
|
44697.80 Activity Counts
Standard Deviation 89132.49
|
|
Change in Upper Extremity Position Through Actigraphy
Average y axis change score
|
69125.26 Activity Counts
Standard Deviation 102942.92
|
1279.76 Activity Counts
Standard Deviation 141962.15
|
|
Change in Upper Extremity Position Through Actigraphy
Average z axis change score
|
59784.84 Activity Counts
Standard Deviation 91039.70
|
17297.11 Activity Counts
Standard Deviation 130688.29
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Armon Ayura (Kinova)
n=11 Participants
Participants will trial the Armon Ayura dynamic arm support.
Armon Ayura (Kinova): Actively assisted mechanical arm support (electric powered to balance arm)
|
JAECO WREX
n=4 Participants
Participants will trial the JAECO Wilmington Robotic EXoskeleton (WREX) dynamic arm support.
JAECO Wrex: Passive mechanical arm support (elastic bands to balance arm)
|
|---|---|---|
|
Goal Attainment Scale (GAS)
Goal 1
|
3.09 score on a scale
Standard Deviation 0.83
|
3.5 score on a scale
Standard Deviation 1.0
|
|
Goal Attainment Scale (GAS)
Goal 2
|
2.72 score on a scale
Standard Deviation 1.9
|
2.75 score on a scale
Standard Deviation 1.9
|
|
Goal Attainment Scale (GAS)
Goal 3
|
3.18 score on a scale
Standard Deviation 0.87
|
3.5 score on a scale
Standard Deviation 0.58
|
Adverse Events
Armon Ayura (Kinova)
JAECO WREX
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Roxanna M. Bendixen, Principal Investigator
University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place