Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Sponsor
Albert Einstein Healthcare Network (Other)
Overall Status
Completed
CT.gov ID
NCT01662960
Collaborator
(none)
72
1
2
53.7
1.3
Study Details
Study Description
Brief Summary
The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study will compare two forms of home-based treatment for post-stroke problems making movements with the arms and hands. After initial pre-treatment assessments, participants will complete 4 weeks of treatment, with assessments after each week of treatment and 3 months after the completion of treatment.
Study Design
Study Type:
Interventional
Actual Enrollment
:
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Actual Study Start Date
:
Sep 7, 2012
Actual Primary Completion Date
:
Feb 27, 2017
Actual Study Completion Date
:
Feb 27, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mirror therapy 4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm. |
Behavioral: Mirror therapy
A home-based therapy involving mirrored visual feedback
|
| Active Comparator: Divider therapy 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. |
Behavioral: Divider therapy
A home-based therapy involving removed visual feedback.
|
Outcome Measures
Primary Outcome Measures
- Upper Extremity Fugl-Meyer [Immediately after 1 month of treatment]
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.
- Action Research Arm Test [1 month]
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.
- Rivermead Assessment of Somatosensory Performance [1 month]
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.
- Virtual-reality Assessment of Navigation [1 month]
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.
Secondary Outcome Measures
- Stroke Impact Scale [1 month]
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.
- Wolf Motor Function Test [1 months]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
6 months or more post-stroke
-
upper extremity Fugl-Meyer score between 10 and 50
-
no longer participating in upper-extremity physical or occupational therapy
-
sufficient comprehension ability to understand instructions
Exclusion Criteria:
-
previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)
-
dementia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Einstein Medical Center Elkins Park | Elkins Park | Pennsylvania | United States | 19027 |
Sponsors and Collaborators
- Albert Einstein Healthcare Network
Investigators
- Principal Investigator: Steven Jax, Ph. D., Albert Einstein Healthcare Network
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Steve Jax,
Institute Scientist,
Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT01662960
Other Study ID Numbers:
- HN 4404
- NIH R01 HD068565
First Posted:
Aug 13, 2012
Last Update Posted:
Jun 30, 2020
Last Verified:
Jun 1, 2020
Keywords provided by Steve Jax,
Institute Scientist,
Albert Einstein Healthcare Network
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Period Title: End of 4 Week Treatment Period | ||||
| STARTED | 25 | 23 | 9 | 15 |
| COMPLETED | 24 | 19 | 8 | 15 |
| NOT COMPLETED | 1 | 4 | 1 | 0 |
| Period Title: End of 4 Week Treatment Period | ||||
| STARTED | 24 | 19 | 8 | 15 |
| COMPLETED | 21 | 16 | 5 | 13 |
| NOT COMPLETED | 3 | 3 | 3 | 2 |
Baseline Characteristics
| Arm/Group Title | Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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 of all reporting groups |
| Overall Participants | 25 | 23 | 9 | 15 | 72 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
60.7
(12.3)
|
53.7
(14.9)
|
55.9
(9.7)
|
57.5
(12.7)
|
57.3
(13.0)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
8
32%
|
9
39.1%
|
4
44.4%
|
4
26.7%
|
25
34.7%
|
| Male |
17
68%
|
14
60.9%
|
5
55.6%
|
11
73.3%
|
47
65.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
1
4%
|
1
4.3%
|
0
0%
|
1
6.7%
|
3
4.2%
|
| Not Hispanic or Latino |
24
96%
|
22
95.7%
|
9
100%
|
14
93.3%
|
69
95.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
4%
|
0
0%
|
0
0%
|
0
0%
|
1
1.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
11
44%
|
10
43.5%
|
4
44.4%
|
7
46.7%
|
32
44.4%
|
| White |
12
48%
|
12
52.2%
|
5
55.6%
|
7
46.7%
|
36
50%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
4%
|
1
4.3%
|
0
0%
|
1
6.7%
|
3
4.2%
|
| Upper Extremity Fugl-Meyer (score on a scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [score on a scale] |
39.1
(6.1)
|
17.5
(4.2)
|
39.9
(7.8)
|
18.8
(6.1)
|
28.1
(12.1)
|
| Action Research Arm Test (score on a scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [score on a scale] |
36.1
(9.9)
|
5.8
(4.4)
|
36.3
(13.3)
|
6.7
(4.4)
|
20.3
(17.1)
|
| Rivermead Assessment of Somatosensory Performance (Proportion of items correct) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Proportion of items correct] |
0.72
(0.17)
|
0.53
(0.19)
|
0.79
(0.20)
|
0.56
(0.21)
|
0.63
(0.21)
|
| Stroke Impact Scale (score on a scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [score on a scale] |
215.9
(26.4)
|
219.9
(35.0)
|
226.3
(15.3)
|
215.7
(28.7)
|
218.4
(30.2)
|
| Wolf Motor Function Test (score on a scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [score on a scale] |
48.8
(9.5)
|
22.7
(5.7)
|
50.8
(14.4)
|
25.1
(7.2)
|
35.8
(15.5)
|
| Virtual-reality Assessment of Navigation (proportion difference) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [proportion difference] |
.047
(.051)
|
.056
(.059)
|
.022
(.036)
|
.063
(.086)
|
.050
(.062)
|
Outcome Measures
| Title | Upper Extremity Fugl-Meyer |
|---|---|
| Description | 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. |
| Time Frame | Immediately after 1 month of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed. |
| Arm/Group Title | Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Measure Participants | 25 | 23 | 9 | 15 |
| Mean (Standard Deviation) [score on a scale] |
43.8
(9.4)
|
21.4
(5.7)
|
42.8
(8.7)
|
21.5
(6.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Mirror Therapy: High Functioning, Mirror Therapy: Low Functioning, Divider Therapy: High Functioning, Divider Therapy: Low Functioning |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Test for the superiority of Mirror therapy over Divider therapy. | |
| Statistical Test of Hypothesis | p-Value | .443 |
| Comments | ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 2.2 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Action Research Arm Test |
|---|---|
| Description | 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. |
| Time Frame | 1 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed. |
| Arm/Group Title | Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Measure Participants | 25 | 23 | 9 | 15 |
| Mean (Standard Deviation) [score on a scale] |
39.9
(11.8)
|
7.1
(5.0)
|
39.1
(13.6)
|
7.7
(5.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Mirror Therapy: High Functioning, Mirror Therapy: Low Functioning, Divider Therapy: High Functioning, Divider Therapy: Low Functioning |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Test for the superiority of Mirror therapy over Divider therapy. | |
| Statistical Test of Hypothesis | p-Value | .80 |
| Comments | ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.4 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Rivermead Assessment of Somatosensory Performance |
|---|---|
| Description | 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. |
| Time Frame | 1 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed. |
| Arm/Group Title | Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Measure Participants | 25 | 23 | 9 | 15 |
| Mean (Standard Deviation) [Proportion of items correct.] |
0.76
(0.18)
|
0.52
(0.19)
|
0.79
(0.18)
|
0.60
(0.20)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Mirror Therapy: High Functioning, Mirror Therapy: Low Functioning, Divider Therapy: High Functioning, Divider Therapy: Low Functioning |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Test for the superiority of Mirror therapy over Divider therapy. | |
| Statistical Test of Hypothesis | p-Value | .93 |
| Comments | ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -.002 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Virtual-reality Assessment of Navigation |
|---|---|
| Description | 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. |
| Time Frame | 1 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Measure Participants | 0 | 0 | 0 | 0 |
| Title | Stroke Impact Scale |
|---|---|
| Description | 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. |
| Time Frame | 1 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed. |
| Arm/Group Title | Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Measure Participants | 25 | 23 | 9 | 15 |
| Mean (Standard Deviation) [score on a scale] |
221.0
(32.5)
|
231.6
(43.7)
|
237.8
(25.7)
|
217.0
(26.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Mirror Therapy: High Functioning, Mirror Therapy: Low Functioning, Divider Therapy: High Functioning, Divider Therapy: Low Functioning |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Test for the superiority of Mirror therapy over Divider therapy. | |
| Statistical Test of Hypothesis | p-Value | .28 |
| Comments | ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 10.7 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Wolf Motor Function Test |
|---|---|
| Description | 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. |
| Time Frame | 1 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed. |
| Arm/Group Title | Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Measure Participants | 25 | 23 | 9 | 15 |
| Mean (Standard Deviation) [score on a scale] |
50.0
(10.0)
|
22.3
(6.0)
|
50.4
(13.8)
|
24.7
(6.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Mirror Therapy: High Functioning, Mirror Therapy: Low Functioning, Divider Therapy: High Functioning, Divider Therapy: Low Functioning |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Test for the superiority of Mirror therapy over Divider therapy. | |
| Statistical Test of Hypothesis | p-Value | .86 |
| Comments | ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -.36 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From Baseline screening until 3-month post-treatment follow-up. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning | ||||
| Arm/Group Description | 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. | 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. | 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. | 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. | ||||
All Cause Mortality |
||||||||
| Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/23 (0%) | 0/9 (0%) | 0/15 (0%) | ||||
Serious Adverse Events |
||||||||
| Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/23 (0%) | 0/9 (0%) | 0/15 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Mirror Therapy: High Functioning | Mirror Therapy: Low Functioning | Divider Therapy: High Functioning | Divider Therapy: Low Functioning | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/23 (0%) | 0/9 (0%) | 0/15 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Steven Jax |
|---|---|
| Organization | Albert Einstein Healthcare Network |
| Phone | 215-870-0196 |
| stevenandrewjax@gmail.com |
Responsible Party:
Steve Jax,
Institute Scientist,
Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT01662960
Other Study ID Numbers:
- HN 4404
- NIH R01 HD068565
First Posted:
Aug 13, 2012
Last Update Posted:
Jun 30, 2020
Last Verified:
Jun 1, 2020