Trial Outcomes & Findings for Usability Testing of Affordable Haptic Robots for Stroke Therapy (NCT NCT02772809)
NCT ID: NCT02772809
Last Updated: 2020-09-04
Results Overview
The primary outcomes are motor control for the upper limb: Subjects completed tasks on scale; Motor scale maximum is 66. minimum is 0. Lower is more impaired. Higher is less impaired.
TERMINATED
NA
23 participants
At 0 weeks
2020-09-04
Participant Flow
Stroke survivors over the age of 18 with hemiplegia, who are three months post event, and have varying levels of impairment in the upper extremities will be recruited. All use of the TheraDrive system will take place at the Rehabilitation Robotics Lab on the first floor of Penn Rittenhouse
Participant milestones
| Measure |
Stroke Survivors With Varying Levels of Motor Impairment
Stroke survivors with varying levels of motor deficit impairment in their upper extremity.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Stroke Survivors With Varying Levels of Motor Impairment
Stroke survivors with varying levels of motor deficit impairment in their upper extremity.
|
|---|---|
|
Overall Study
not completed some tasks
|
6
|
Baseline Characteristics
6 persons did not complete all of the tracking tasks so the data was excluded.
Baseline characteristics by cohort
| Measure |
Subjects With Varying Levels of Motor Impairment
n=23 Participants
Subjects with varying levels of motor impairments who are ages 18 and older.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=17 Participants • 6 persons did not complete all of the tracking tasks so the data was excluded.
|
|
Sex: Female, Male
Male
|
8 Participants
n=17 Participants • 6 persons did not complete all of the tracking tasks so the data was excluded.
|
PRIMARY outcome
Timeframe: At 0 weeksPopulation: 6 subjects did not complete so not included in the analysis
The primary outcomes are motor control for the upper limb: Subjects completed tasks on scale; Motor scale maximum is 66. minimum is 0. Lower is more impaired. Higher is less impaired.
Outcome measures
| Measure |
Stroke Survivors With Motor Impairment
n=17 Participants
All subject used robot for tracking tasks
|
|---|---|
|
Fugl Meyer
|
42.5 score on a scale
Standard Deviation 20.2
|
PRIMARY outcome
Timeframe: At Session 0. Pre-interventionPopulation: 6 subjects did not complete so not included in the analysis
Measures ADL Function. Completed reach and grasp activities. Reached for 1 inch cube and placed with impaired arm. More blocks indicate higher function. Less blocks lower function
Outcome measures
| Measure |
Stroke Survivors With Motor Impairment
n=17 Participants
All subject used robot for tracking tasks
|
|---|---|
|
Box and Blocks
|
19.11 # of blocks
Standard Deviation 15.49
|
PRIMARY outcome
Timeframe: At Session 0Population: 6 subjects did not complete so not included in the analysis
Tracking accuracy is measured using the normalized root mean square, which is a measure for error in tracking performance with respect to a desired goal. Root mean squared divided by the maximum error if person does not move. The higher the decimal the higher the error made. Lower is better performance.
Outcome measures
| Measure |
Stroke Survivors With Motor Impairment
n=17 Participants
All subject used robot for tracking tasks
|
|---|---|
|
Tracking Accuracy
|
0.73 accuracy index
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: pre-interventionPopulation: 6 subjects did not complete so not included in the analysis
Grip strength as measured by a dynamometer. Subjects were asked to squeeze a dynamometer with impaired arm. Higher forces mean better function
Outcome measures
| Measure |
Stroke Survivors With Motor Impairment
n=17 Participants
All subject used robot for tracking tasks
|
|---|---|
|
Grip Strength
|
26.88 lbs
Standard Deviation 22.73
|
SECONDARY outcome
Timeframe: pre-interventionPopulation: 6 subjects did not complete so not included in the analysis
A brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for impairment in cognition domains. Maximum is 30. Minimum is 0; Low is \<17 is severe cognitive impairment; a score 26 and higher is normal cognition.
Outcome measures
| Measure |
Stroke Survivors With Motor Impairment
n=17 Participants
All subject used robot for tracking tasks
|
|---|---|
|
Montreal Cognitive Assessment (MOCA)
|
22.5 units on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Pre-interventionPopulation: 6 subjects did not complete so not included in the analysis
Measures depression. The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1961). Maximum is 63 Total Score\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Levels of Depression 1-10\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_These ups and downs are considered normal 11-16\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Mild mood disturbance 17-20\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Borderline clinical depression 21-30\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Moderate depression 31-40\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Severe depression over 40\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Extreme depression
Outcome measures
| Measure |
Stroke Survivors With Motor Impairment
n=17 Participants
All subject used robot for tracking tasks
|
|---|---|
|
Becks Depression Scale
|
7.25 units on a scale
Standard Deviation 5.72
|
Adverse Events
Haptic Robot Therapy With Games
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