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| ID | Type | Description | Link |
|---|---|---|---|
| NIH R01 HD068565 | Other Identifier | Einstein Healthcare Network |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirror therapy | Experimental | 4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm. |
|
| Divider therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirror therapy | Behavioral | A home-based therapy involving mirrored visual feedback |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Extremity Fugl-Meyer | 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. | Immediately after 1 month of treatment |
| Action Research Arm Test | 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. | 1 month |
| Rivermead Assessment of Somatosensory Performance | 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. | 1 month |
| Virtual-reality Assessment of Navigation | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale | 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. | 1 month |
| Wolf Motor Function Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Jax, Ph. D. | Albert Einstein Healthcare Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Einstein Medical Center Elkins Park | Elkins Park | Pennsylvania | 19027 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| End of 4 Week Treatment Period |
| |||||||||||||
| 3 Month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Mirror Therapy: Low Functioning |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Upper Extremity Fugl-Meyer | 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. | All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed. | Posted | Mean | Standard Deviation | score on a scale | Immediately after 1 month of treatment |
|
From Baseline screening until 3-month post-treatment follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Jax | Albert Einstein Healthcare Network | 215-870-0196 | stevenandrewjax@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2016 | Jan 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010291 | Paresis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000088762 | Mirror Movement Therapy |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
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| Divider therapy |
| Behavioral |
A home-based therapy involving removed visual feedback. |
|
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. |
| 1 months |
| COMPLETED |
|
| NOT COMPLETED |
|
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Upper Extremity Fugl-Meyer | 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. | Mean | Standard Deviation | score on a scale |
|
| Action Research Arm Test | 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. | Mean | Standard Deviation | score on a scale |
|
| Rivermead Assessment of Somatosensory Performance | 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. | Mean | Standard Deviation | Proportion of items correct |
|
| Stroke Impact Scale | 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. | Mean | Standard Deviation | score on a scale |
|
| Wolf Motor Function Test | 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. | Mean | Standard Deviation | score on a scale |
|
| Virtual-reality Assessment of Navigation | 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. | Mean | Standard Deviation | proportion difference |
|
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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| Primary | Action Research Arm Test | 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. | All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed. | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
|
| Primary | Rivermead Assessment of Somatosensory Performance | 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. | All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed. | Posted | Mean | Standard Deviation | Proportion of items correct. | 1 month |
|
|
|
|
| Primary | Virtual-reality Assessment of Navigation | 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. | 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. | Posted | 1 month |
|
|
| Secondary | Stroke Impact Scale | 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. | All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed. | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
|
| Secondary | Wolf Motor Function Test | 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. | All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed. | Posted | Mean | Standard Deviation | score on a scale | 1 months |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |