Stroke
Conditions
Brief summary
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.
Interventions
DEVICERobotic arm therapy
Training with the ReoGo device
Sponsors
Orentreich Family Foundation
Mailman School of Public Health
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hemiparesis of the upper extremity 2. Diagnosis of a first clinically apparent ischemic stroke at least 6 months prior to study entry 3. Age 18 years or older 4. Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory disturbances and/or pain.
Exclusion criteria
1. Inability to understand and/or follow instructions 2. Pain in shoulder or arm 3. Other neurological or musculoskeletal target organ disorder 4. Inability to give informed consent personally 5. Previous or current contracture of the upper extremity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance | From baseline to within 1 week post-therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer (FM) Upper Extremity Motor Assessment | baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy | 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. |
| Action Research Arm Test | baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy | 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. |
Countries
United States
Participant flow
Recruitment details
Patients with post-stroke arm paresis were recruited from June 2009 to May 2011
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Robot Arm Rehabilitation Therapy |
|---|---|
| Age, Continuous | 59 years |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 8 Participants |
| Stroke Side Left | 7 Participants |
| Stroke Side Right | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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.
Time frame: From baseline to within 1 week post-therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Robot Arm Rehabilitation Therapy | Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance | -16.31 unitless |
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.
Time frame: baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robot Arm Rehabilitation Therapy | Action Research Arm Test | Pretest 1: 3 weeks before baseline | 19.6 score on a scale | Standard Deviation 18 |
| Robot Arm Rehabilitation Therapy | Action Research Arm Test | Pretest 2: 1 week before baseline | 21.3 score on a scale | Standard Deviation 17.1 |
| Robot Arm Rehabilitation Therapy | Action Research Arm Test | Posttest 1: 1 week after therapy | 23.7 score on a scale | Standard Deviation 18.6 |
| Robot Arm Rehabilitation Therapy | Action Research Arm Test | Posttest 2: 3 weeks after therapy | 25.0 score on a scale | Standard Deviation 16.7 |
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.
Time frame: baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robot Arm Rehabilitation Therapy | Fugl-Meyer (FM) Upper Extremity Motor Assessment | Pretest 1: 3 weeks before baseline | 30.3 score on a scale | Standard Deviation 15.8 |
| Robot Arm Rehabilitation Therapy | Fugl-Meyer (FM) Upper Extremity Motor Assessment | Pretest 2: 1 week before baseline | 32.8 score on a scale | Standard Deviation 17.4 |
| Robot Arm Rehabilitation Therapy | Fugl-Meyer (FM) Upper Extremity Motor Assessment | Posttest 1: 1 week after therapy | 36.0 score on a scale | Standard Deviation 14.6 |
| Robot Arm Rehabilitation Therapy | Fugl-Meyer (FM) Upper Extremity Motor Assessment | Posttest 2: 3 weeks after therapy | 38.3 score on a scale | Standard Deviation 15.5 |