Trial Outcomes & Findings for Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke (NCT NCT03995069)
NCT ID: NCT03995069
Last Updated: 2025-07-11
Results Overview
change in a clinical assessment, ARAT, that is in a scale 0-57 with a higher score representing better upper extremity function
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
baseline to within 1 week post intervention
Results posted on
2025-07-11
Participant Flow
Not meeting inclusion criteria (n=1) Declined to participate (n=3) Funding ended (n=2)
Participant milestones
| Measure |
Visual Feedback of 3D Digit Force
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.
|
Visual Feedback of 1D Digit Force
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
Baseline characteristics by cohort
| Measure |
Visual Feedback of 3D Digit Force
n=22 Participants
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.
|
Visual Feedback of 1D Digit Force
n=23 Participants
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 12 • n=99 Participants
|
60 years
STANDARD_DEVIATION 9 • n=107 Participants
|
59 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline to within 1 week post interventionchange in a clinical assessment, ARAT, that is in a scale 0-57 with a higher score representing better upper extremity function
Outcome measures
| Measure |
Visual Feedback of 3D Digit Force
n=17 Participants
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.
|
Visual Feedback of 1D Digit Force
n=19 Participants
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.
|
|---|---|---|
|
Action Research Arm Test (ARAT)
|
3.5 score on a scale
Standard Error 0.65
|
0.8 score on a scale
Standard Error 0.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to within 1 week post interventiona clinical assessment measuring the number of blocks that a person can move in a minute, with a higher score representing better upper extremity function
Outcome measures
| Measure |
Visual Feedback of 3D Digit Force
n=17 Participants
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.
|
Visual Feedback of 1D Digit Force
n=19 Participants
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.
|
|---|---|---|
|
Box and Block Test
|
3.03 blocks moved in 1 min
Standard Error 0.97
|
0.92 blocks moved in 1 min
Standard Error 0.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to within 1 week post interventionPerceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).
Outcome measures
| Measure |
Visual Feedback of 3D Digit Force
n=17 Participants
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.
|
Visual Feedback of 1D Digit Force
n=19 Participants
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.
|
|---|---|---|
|
Stroke Impact Scale Hand Subscale
|
12 score on a scale
Standard Error 2
|
6 score on a scale
Standard Error 2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 1 month post interventionchange in a clinical assessment of Action Research Arm Test that is in a scale 0-57 with a higher score representing better upper extremity function
Outcome measures
| Measure |
Visual Feedback of 3D Digit Force
n=16 Participants
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.
|
Visual Feedback of 1D Digit Force
n=17 Participants
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.
|
|---|---|---|
|
Action Research Arm Test
|
3.9 score on a scale
Standard Error 0.7
|
0.7 score on a scale
Standard Error 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 1 month post interventiona clinical assessment for upper extremity function.
Outcome measures
| Measure |
Visual Feedback of 3D Digit Force
n=16 Participants
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.
|
Visual Feedback of 1D Digit Force
n=17 Participants
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.
|
|---|---|---|
|
Box and Block Test
|
2.5 blocks moved in 1 min
Standard Error 1
|
0.5 blocks moved in 1 min
Standard Error 1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 1 month post interventionPerceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).
Outcome measures
| Measure |
Visual Feedback of 3D Digit Force
n=16 Participants
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.
|
Visual Feedback of 1D Digit Force
n=17 Participants
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.
|
|---|---|---|
|
Stroke Impact Scale Hand Subscale
|
15 score on a scale
Standard Error 2
|
8 score on a scale
Standard Error 2
|
Adverse Events
Visual Feedback of 3D Digit Force
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Visual Feedback of 1D Digit Force
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Visual Feedback of 3D Digit Force
n=22 participants at risk
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.
|
Visual Feedback of 1D Digit Force
n=23 participants at risk
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.
|
|---|---|---|
|
General disorders
drug abuse
|
4.5%
1/22 • During the study participation (approximately 10 weeks)
|
0.00%
0/23 • During the study participation (approximately 10 weeks)
|
|
Nervous system disorders
tremor with new seizure medication
|
4.5%
1/22 • During the study participation (approximately 10 weeks)
|
0.00%
0/23 • During the study participation (approximately 10 weeks)
|
|
General disorders
car accident
|
0.00%
0/22 • During the study participation (approximately 10 weeks)
|
4.3%
1/23 • During the study participation (approximately 10 weeks)
|
|
General disorders
transient amnesia, blackout
|
0.00%
0/22 • During the study participation (approximately 10 weeks)
|
8.7%
2/23 • During the study participation (approximately 10 weeks)
|
Other adverse events
| Measure |
Visual Feedback of 3D Digit Force
n=22 participants at risk
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.
|
Visual Feedback of 1D Digit Force
n=23 participants at risk
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.
|
|---|---|---|
|
General disorders
other adverse events
|
81.8%
18/22 • During the study participation (approximately 10 weeks)
|
78.3%
18/23 • During the study participation (approximately 10 weeks)
|
Additional Information
Principal Investigator
Ralph H. Johnson VA Health Care System
Phone: 8434671373
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place