Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R44NS060192-03 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
| Northwestern University | OTHER |
| Shirley Ryan AbilityLab | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy device (AMES).
Our research objective is to develop procedures to rehabilitate those stroke patients who, through conventional therapies, are not brought to a level of maximal recovery. The aims of the proposed project are to obtain a set of data from a total of 20 chronic stroke subjects, all with severe lower extremity disability, between the ages of 18-85, using a robotic therapeutic device placed in a rehabilitation clinic. This data will allow us to quantify the extent to which a combination of robotic-assisted exercise and tendon vibration from the AMES beta device induces secondary recovery from the effects of stroke on the lower extremity.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMES Leg treatment | Experimental | An investigational device flexes and extends the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the foot. The subject's task is to assist the motion of the device by pulling or pushing with the foot. Feedback of ankle torque or the electrical signal produced by the muscles (EMG) while the subject is assisting the motion is provided during the 30 treatment sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMES- Leg treatment | Device | 30 minutes of treatment of the leg consisting of the AMES device passively moving the ankle between plantarflexion and dorsiflexion with vibration of the tendons being stretched, while the participant tries to assist in the movement as much as possible. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Motor Assessment of the Lower Affected Extremity | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Assessment | The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test. | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments |
| Modified Ashworth Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barry Oken, MD | Oregon Health and Science University | Principal Investigator |
| Elliot Roth, MD | Northwestern University/Rehabilitation Institute of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University/Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Measurement of spasticity in the ankle joint. |
| Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments |
| Dynamic Balance/Weight Distribution | Measure the subject's right-left weight distribution and dynamic balance control. | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments |
| Ankle Strength | Measurement of three attempts of dorsiflexion and three attempts of plantarflexion. | Prior to each treatment session, |
| Passive Motion Test | Measures the peak resistance in the affected ankle. | Prior to each treatment session |
| Active Range of Motion Test | A joint tracking task guided by visual feedback on a computer screen. | Prior to each treatment session |
| Oregon Health and Science University |
| Portland |
| Oregon |
| 97006 |
| United States |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |