Trial Outcomes & Findings for Effects of a Compliant Arm Support on Post-stroke Upper Extremity Range of Motion (NCT NCT03867838)
NCT ID: NCT03867838
Last Updated: 2021-02-23
Results Overview
Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters).
COMPLETED
NA
6 participants
baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment)
2021-02-23
Participant Flow
Participants were screened to include only those whose most recent stroke occurred more than 6 months before the study date and to exclude those with conflating health problems, sensory deficits, or that experience pain during passive movements of the arm.
Participant milestones
| Measure |
All Participants
Stroke survivors with upper extremity motor impairments
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=6 Participants
Stroke survivors with upper extremity motor impairments
|
|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 10 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants
|
|
Fugl-Meyer Assessment of sensorimotor function
|
27 units on a scale
STANDARD_DEVIATION 13 • n=6 Participants
|
|
Correct scapulohumeral rhythm
|
6 Participants
n=6 Participants
|
|
Spatial neglect
|
0 Participants
n=6 Participants
|
|
Reachable workspace
|
0.10 m^2
STANDARD_DEVIATION 0.11 • n=6 Participants
|
|
Biceps activation
|
0.19 mV
STANDARD_DEVIATION 0.25 • n=6 Participants
|
PRIMARY outcome
Timeframe: baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment)Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters).
Outcome measures
| Measure |
All Participants
n=6 Participants
Stroke survivors with upper extremity motor impairments
|
|---|---|
|
Percent Change From Baseline in Reachable Workspace
On support device
|
27 percent change
Standard Deviation 84
|
|
Percent Change From Baseline in Reachable Workspace
Post support device
|
-71 percent change
Standard Deviation 41
|
SECONDARY outcome
Timeframe: baseline and while using support device (up to 10 seconds per assessment)Biceps activation measured using surface electromyography during an isometric hold to approximate the contributions of erroneous flexor synergies.
Outcome measures
| Measure |
All Participants
n=6 Participants
Stroke survivors with upper extremity motor impairments
|
|---|---|
|
Percent Change From Baseline in Biceps Activation
|
-16 percent change
Standard Deviation 71
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place