AMES Treatment of the Impaired Leg in Chronic Stroke Patients
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AMES Leg treatment 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. |
Device: AMES- Leg treatment
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.
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- Gait Assessment [Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments]
The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test.
- Modified Ashworth Scale [Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments]
Measurement of spasticity in the ankle joint.
- Dynamic Balance/Weight Distribution [Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments]
Measure the subject's right-left weight distribution and dynamic balance control.
- Ankle Strength [Prior to each treatment session,]
Measurement of three attempts of dorsiflexion and three attempts of plantarflexion.
- Passive Motion Test [Prior to each treatment session]
Measures the peak resistance in the affected ankle.
- Active Range of Motion Test [Prior to each treatment session]
A joint tracking task guided by visual feedback on a computer screen.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Spastic hemiparesis
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At least 12 months post-stroke
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Can comfortably fit foot in treatment device
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Functioning proprioception
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Fugl-Meyer LE score >6 and <23
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Minimal hemi-neglect
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Observable volitional movement of the ankle in either plantar- or dorsi-flexion
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Cognitively and behaviorally capable of complying with the regimen
Exclusion Criteria:
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Fractures of treated limb resulting in loss of range of motion
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Spinal cord injury
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Deep venous thrombosis
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Peripheral nerve injury or neuropathy in the affected limb with motor disability
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Osteoarthritis limiting range of motion
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Uncontrolled high blood pressure/angina
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Exercise intolerant
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Skin condition not tolerant of device
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Progressive neurodegenerative disorder
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Uncontrolled seizure disorder
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Botox treatment within last 5 months
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Baclofen pump
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University/Rehabilitation Institute of Chicago | Chicago | Illinois | United States | 60611 |
| 2 | Oregon Health and Science University | Portland | Oregon | United States | 97006 |
Sponsors and Collaborators
- AMES Technology
- Oregon Health and Science University
- Northwestern University
- Shirley Ryan AbilityLab
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: Barry Oken, MD, Oregon Health and Science University
- Principal Investigator: Elliot Roth, MD, Northwestern University/Rehabilitation Institute of Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 7034
- R44NS060192-03