Trial Outcomes & Findings for Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke (NCT NCT01662960)
NCT ID: NCT01662960
Last Updated: 2020-06-30
Results Overview
This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Immediately after 1 month of treatment
Results posted on
2020-06-30
Participant Flow
Participant milestones
| Measure |
Mirror Therapy: High Functioning
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Mirror Therapy: Low Functioning
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
Divider Therapy: High Functioning
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Divider Therapy: Low Functioning
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
|---|---|---|---|---|
|
End of 4 Week Treatment Period
STARTED
|
25
|
23
|
9
|
15
|
|
End of 4 Week Treatment Period
COMPLETED
|
24
|
19
|
8
|
15
|
|
End of 4 Week Treatment Period
NOT COMPLETED
|
1
|
4
|
1
|
0
|
|
3 Month Follow-up
STARTED
|
24
|
19
|
8
|
15
|
|
3 Month Follow-up
COMPLETED
|
21
|
16
|
5
|
13
|
|
3 Month Follow-up
NOT COMPLETED
|
3
|
3
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Baseline characteristics by cohort
| Measure |
Mirror Therapy: High Functioning
n=25 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Mirror Therapy: Low Functioning
n=23 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
Divider Therapy: High Functioning
n=9 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Divider Therapy: Low Functioning
n=15 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.7 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
53.7 Years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
55.9 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
57.5 Years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
57.3 Years
STANDARD_DEVIATION 13.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Upper Extremity Fugl-Meyer
|
39.1 score on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
17.5 score on a scale
STANDARD_DEVIATION 4.2 • n=7 Participants
|
39.9 score on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
18.8 score on a scale
STANDARD_DEVIATION 6.1 • n=4 Participants
|
28.1 score on a scale
STANDARD_DEVIATION 12.1 • n=21 Participants
|
|
Action Research Arm Test
|
36.1 score on a scale
STANDARD_DEVIATION 9.9 • n=5 Participants
|
5.8 score on a scale
STANDARD_DEVIATION 4.4 • n=7 Participants
|
36.3 score on a scale
STANDARD_DEVIATION 13.3 • n=5 Participants
|
6.7 score on a scale
STANDARD_DEVIATION 4.4 • n=4 Participants
|
20.3 score on a scale
STANDARD_DEVIATION 17.1 • n=21 Participants
|
|
Rivermead Assessment of Somatosensory Performance
|
0.72 Proportion of items correct
STANDARD_DEVIATION 0.17 • n=5 Participants
|
0.53 Proportion of items correct
STANDARD_DEVIATION 0.19 • n=7 Participants
|
0.79 Proportion of items correct
STANDARD_DEVIATION 0.20 • n=5 Participants
|
0.56 Proportion of items correct
STANDARD_DEVIATION 0.21 • n=4 Participants
|
0.63 Proportion of items correct
STANDARD_DEVIATION 0.21 • n=21 Participants
|
|
Stroke Impact Scale
|
215.9 score on a scale
STANDARD_DEVIATION 26.4 • n=5 Participants
|
219.9 score on a scale
STANDARD_DEVIATION 35.0 • n=7 Participants
|
226.3 score on a scale
STANDARD_DEVIATION 15.3 • n=5 Participants
|
215.7 score on a scale
STANDARD_DEVIATION 28.7 • n=4 Participants
|
218.4 score on a scale
STANDARD_DEVIATION 30.2 • n=21 Participants
|
|
Wolf Motor Function Test
|
48.8 score on a scale
STANDARD_DEVIATION 9.5 • n=5 Participants
|
22.7 score on a scale
STANDARD_DEVIATION 5.7 • n=7 Participants
|
50.8 score on a scale
STANDARD_DEVIATION 14.4 • n=5 Participants
|
25.1 score on a scale
STANDARD_DEVIATION 7.2 • n=4 Participants
|
35.8 score on a scale
STANDARD_DEVIATION 15.5 • n=21 Participants
|
|
Virtual-reality Assessment of Navigation
|
.047 proportion difference
STANDARD_DEVIATION .051 • n=5 Participants
|
.056 proportion difference
STANDARD_DEVIATION .059 • n=7 Participants
|
.022 proportion difference
STANDARD_DEVIATION .036 • n=5 Participants
|
.063 proportion difference
STANDARD_DEVIATION .086 • n=4 Participants
|
.050 proportion difference
STANDARD_DEVIATION .062 • n=21 Participants
|
PRIMARY outcome
Timeframe: Immediately after 1 month of treatmentPopulation: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.
This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.
Outcome measures
| Measure |
Divider Therapy: High Functioning
n=9 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Divider Therapy: Low Functioning
n=15 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
Mirror Therapy: High Functioning
n=25 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Mirror Therapy: Low Functioning
n=23 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
|---|---|---|---|---|
|
Upper Extremity Fugl-Meyer
|
42.8 score on a scale
Standard Deviation 8.7
|
21.5 score on a scale
Standard Deviation 6.3
|
43.8 score on a scale
Standard Deviation 9.4
|
21.4 score on a scale
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: 1 monthPopulation: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.
The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.
Outcome measures
| Measure |
Divider Therapy: High Functioning
n=9 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Divider Therapy: Low Functioning
n=15 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
Mirror Therapy: High Functioning
n=25 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Mirror Therapy: Low Functioning
n=23 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
|---|---|---|---|---|
|
Action Research Arm Test
|
39.1 score on a scale
Standard Deviation 13.6
|
7.7 score on a scale
Standard Deviation 5.6
|
39.9 score on a scale
Standard Deviation 11.8
|
7.1 score on a scale
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: 1 monthPopulation: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.
This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.
Outcome measures
| Measure |
Divider Therapy: High Functioning
n=9 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Divider Therapy: Low Functioning
n=15 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
Mirror Therapy: High Functioning
n=25 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Mirror Therapy: Low Functioning
n=23 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
|---|---|---|---|---|
|
Rivermead Assessment of Somatosensory Performance
|
0.79 Proportion of items correct.
Standard Deviation 0.18
|
0.60 Proportion of items correct.
Standard Deviation 0.20
|
0.76 Proportion of items correct.
Standard Deviation 0.18
|
0.52 Proportion of items correct.
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: 1 monthPopulation: No participants were administered the test in the post-treatment phase because no participant exhibited a baseline 20% difference in item detection between the left and right side.
This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthPopulation: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.
This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.
Outcome measures
| Measure |
Divider Therapy: High Functioning
n=9 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Divider Therapy: Low Functioning
n=15 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
Mirror Therapy: High Functioning
n=25 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Mirror Therapy: Low Functioning
n=23 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
|---|---|---|---|---|
|
Stroke Impact Scale
|
237.8 score on a scale
Standard Deviation 25.7
|
217.0 score on a scale
Standard Deviation 26.7
|
221.0 score on a scale
Standard Deviation 32.5
|
231.6 score on a scale
Standard Deviation 43.7
|
SECONDARY outcome
Timeframe: 1 monthsPopulation: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.
The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.
Outcome measures
| Measure |
Divider Therapy: High Functioning
n=9 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Divider Therapy: Low Functioning
n=15 Participants
4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
Mirror Therapy: High Functioning
n=25 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
High functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.
|
Mirror Therapy: Low Functioning
n=23 Participants
4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
Low functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.
|
|---|---|---|---|---|
|
Wolf Motor Function Test
|
50.4 score on a scale
Standard Deviation 13.8
|
24.7 score on a scale
Standard Deviation 6.7
|
50.0 score on a scale
Standard Deviation 10.0
|
22.3 score on a scale
Standard Deviation 6.0
|
Adverse Events
Mirror Therapy: High Functioning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mirror Therapy: Low Functioning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Divider Therapy: High Functioning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Divider Therapy: Low Functioning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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