Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Orentreich Family Foundation | UNKNOWN |
| Mailman School of Public Health | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Stroke is a leading cause of neurological disability worldwide, often causing significant weakening and paresis of the affected arm. National spending on post-stroke rehabilitation is project to expand 20% to 35% through 2010. As a new tool for therapists, robotic stroke therapy devices have the potential to be a cost-effective device aid to physical therapy and enable novel modes of exercise not currently available. While recent studies have shown chronic patients benefit from repetitive practice, it is not clear whether they improved via a reduction in impairment or increased functional compensation because there is a lack of standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients. This study aims to reconcile difference performance measurements in robotic rehabilitation to assess the outcome of robotic rehabilitation training.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot arm rehabilitation therapy | Experimental | Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic arm therapy | Device | Training with the ReoGo device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance | Arm motor control was assessed through analysis of reaching movements to targets. We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance). This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control. | From baseline to within 1 week post-therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer (FM) Upper Extremity Motor Assessment | The FM is a measure of impairment that considers movement arm, wrist, hand, and coordination. Each of the 22 items is scored on a three-point ordinal scale for total score between a minimum score of 0 and a maximum score of 66. A higher score indicates a better outcome. | baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Krakauer, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia Univeristy, Neurological Institute | New York | New York | 10032 | United States |
Not provided
Patients with post-stroke arm paresis were recruited from June 2009 to May 2011
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Robot Arm Rehabilitation Therapy | Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Robot Arm Rehabilitation Therapy | Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device |
| 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 | Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance | Arm motor control was assessed through analysis of reaching movements to targets. We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance). This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control. | Posted | Number | unitless | From baseline to within 1 week post-therapy |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robot Arm Rehabilitation Therapy | Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tomoko Kitago | Columbia University | 212-305-8389 | tk2229@columbia.edu |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Action Research Arm Test | The ARAT tests hand and arm function and consists of 19 items in 4 domains: grasp, grip, pinch, and gross movement. Each domain contains items arranged into hierarchical order of difficulty such that success at the most difficult item of a specific subclass assumes success for all items lower in the hierarchy of the same class. Each item is scored on a four-point ordinal scale for total score between a minimum score of 0 and a maximum score of 57. A higher score indicates a better outcome. | baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Stroke Side | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Fugl-Meyer (FM) Upper Extremity Motor Assessment | The FM is a measure of impairment that considers movement arm, wrist, hand, and coordination. Each of the 22 items is scored on a three-point ordinal scale for total score between a minimum score of 0 and a maximum score of 66. A higher score indicates a better outcome. | Posted | Mean | Standard Deviation | score on a scale | baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy |
|
|
|
| Secondary | Action Research Arm Test | The ARAT tests hand and arm function and consists of 19 items in 4 domains: grasp, grip, pinch, and gross movement. Each domain contains items arranged into hierarchical order of difficulty such that success at the most difficult item of a specific subclass assumes success for all items lower in the hierarchy of the same class. Each item is scored on a four-point ordinal scale for total score between a minimum score of 0 and a maximum score of 57. A higher score indicates a better outcome. | Posted | Mean | Standard Deviation | score on a scale | baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
|
| Posttest 2: 3 weeks after therapy |
|
|
| Posttest 2: 3 weeks after therapy |
|