Hemiparesis, Stroke
Conditions
Keywords
stroke, hemiparesis, arm movement, sensory functioning
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.
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.
Interventions
BEHAVIORALMirror therapy
A home-based therapy involving mirrored visual feedback
BEHAVIORALDivider therapy
A home-based therapy involving removed visual feedback.
Sponsors
Albert Einstein Healthcare Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 23 |
| 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. | 9 |
| 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. | 15 |
| Total | 72 |
Baseline characteristics
| Characteristic | Mirror Therapy: High Functioning | Total | Divider Therapy: Low Functioning | Divider Therapy: High Functioning | Mirror Therapy: Low Functioning |
|---|---|---|---|---|---|
| Action Research Arm Test | 36.1 score on a scale STANDARD_DEVIATION 9.9 | 20.3 score on a scale STANDARD_DEVIATION 17.1 | 6.7 score on a scale STANDARD_DEVIATION 4.4 | 36.3 score on a scale STANDARD_DEVIATION 13.3 | 5.8 score on a scale STANDARD_DEVIATION 4.4 |
| Age, Continuous | 60.7 Years STANDARD_DEVIATION 12.3 | 57.3 Years STANDARD_DEVIATION 13 | 57.5 Years STANDARD_DEVIATION 12.7 | 55.9 Years STANDARD_DEVIATION 9.7 | 53.7 Years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 69 Participants | 14 Participants | 9 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 32 Participants | 7 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 36 Participants | 7 Participants | 5 Participants | 12 Participants |
| Rivermead Assessment of Somatosensory Performance | 0.72 Proportion of items correct STANDARD_DEVIATION 0.17 | 0.63 Proportion of items correct STANDARD_DEVIATION 0.21 | 0.56 Proportion of items correct STANDARD_DEVIATION 0.21 | 0.79 Proportion of items correct STANDARD_DEVIATION 0.2 | 0.53 Proportion of items correct STANDARD_DEVIATION 0.19 |
| Sex: Female, Male Female | 8 Participants | 25 Participants | 4 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 17 Participants | 47 Participants | 11 Participants | 5 Participants | 14 Participants |
| Stroke Impact Scale | 215.9 score on a scale STANDARD_DEVIATION 26.4 | 218.4 score on a scale STANDARD_DEVIATION 30.2 | 215.7 score on a scale STANDARD_DEVIATION 28.7 | 226.3 score on a scale STANDARD_DEVIATION 15.3 | 219.9 score on a scale STANDARD_DEVIATION 35 |
| Upper Extremity Fugl-Meyer | 39.1 score on a scale STANDARD_DEVIATION 6.1 | 28.1 score on a scale STANDARD_DEVIATION 12.1 | 18.8 score on a scale STANDARD_DEVIATION 6.1 | 39.9 score on a scale STANDARD_DEVIATION 7.8 | 17.5 score on a scale STANDARD_DEVIATION 4.2 |
| Virtual-reality Assessment of Navigation | .047 proportion difference STANDARD_DEVIATION 0.051 | .050 proportion difference STANDARD_DEVIATION 0.062 | .063 proportion difference STANDARD_DEVIATION 0.086 | .022 proportion difference STANDARD_DEVIATION 0.036 | .056 proportion difference STANDARD_DEVIATION 0.059 |
| Wolf Motor Function Test | 48.8 score on a scale STANDARD_DEVIATION 9.5 | 35.8 score on a scale STANDARD_DEVIATION 15.5 | 25.1 score on a scale STANDARD_DEVIATION 7.2 | 50.8 score on a scale STANDARD_DEVIATION 14.4 | 22.7 score on a scale STANDARD_DEVIATION 5.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 23 | 0 / 9 | 0 / 15 |
| other Total, other adverse events | 0 / 25 | 0 / 23 | 0 / 9 | 0 / 15 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 | 0 / 9 | 0 / 15 |
Outcome results
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.
Time frame: 1 month
Population: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirror Therapy: High Functioning | Action Research Arm Test | 39.9 score on a scale | Standard Deviation 11.8 |
| Mirror Therapy: Low Functioning | Action Research Arm Test | 7.1 score on a scale | Standard Deviation 5 |
| Divider Therapy: High Functioning | Action Research Arm Test | 39.1 score on a scale | Standard Deviation 13.6 |
| Divider Therapy: Low Functioning | Action Research Arm Test | 7.7 score on a scale | Standard Deviation 5.6 |
p-value: 0.8ANCOVA
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.
Time frame: 1 month
Population: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirror Therapy: High Functioning | Rivermead Assessment of Somatosensory Performance | 0.76 Proportion of items correct. | Standard Deviation 0.18 |
| Mirror Therapy: Low Functioning | Rivermead Assessment of Somatosensory Performance | 0.52 Proportion of items correct. | Standard Deviation 0.19 |
| Divider Therapy: High Functioning | Rivermead Assessment of Somatosensory Performance | 0.79 Proportion of items correct. | Standard Deviation 0.18 |
| Divider Therapy: Low Functioning | Rivermead Assessment of Somatosensory Performance | 0.60 Proportion of items correct. | Standard Deviation 0.2 |
p-value: 0.93ANCOVA
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.
Time frame: Immediately after 1 month of treatment
Population: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirror Therapy: High Functioning | Upper Extremity Fugl-Meyer | 43.8 score on a scale | Standard Deviation 9.4 |
| Mirror Therapy: Low Functioning | Upper Extremity Fugl-Meyer | 21.4 score on a scale | Standard Deviation 5.7 |
| Divider Therapy: High Functioning | Upper Extremity Fugl-Meyer | 42.8 score on a scale | Standard Deviation 8.7 |
| Divider Therapy: Low Functioning | Upper Extremity Fugl-Meyer | 21.5 score on a scale | Standard Deviation 6.3 |
p-value: 0.443ANCOVA
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.
Time frame: 1 month
Population: 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.
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.
Time frame: 1 month
Population: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirror Therapy: High Functioning | Stroke Impact Scale | 221.0 score on a scale | Standard Deviation 32.5 |
| Mirror Therapy: Low Functioning | Stroke Impact Scale | 231.6 score on a scale | Standard Deviation 43.7 |
| Divider Therapy: High Functioning | Stroke Impact Scale | 237.8 score on a scale | Standard Deviation 25.7 |
| Divider Therapy: Low Functioning | Stroke Impact Scale | 217.0 score on a scale | Standard Deviation 26.7 |
p-value: 0.28ANCOVA
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.
Time frame: 1 months
Population: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirror Therapy: High Functioning | Wolf Motor Function Test | 50.0 score on a scale | Standard Deviation 10 |
| Mirror Therapy: Low Functioning | Wolf Motor Function Test | 22.3 score on a scale | Standard Deviation 6 |
| Divider Therapy: High Functioning | Wolf Motor Function Test | 50.4 score on a scale | Standard Deviation 13.8 |
| Divider Therapy: Low Functioning | Wolf Motor Function Test | 24.7 score on a scale | Standard Deviation 6.7 |
p-value: 0.86ANCOVA