AMES Treatment of the Impaired Leg in Chronic Stroke Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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AMES Treatment of the Impaired Leg in Chronic Stroke Patients

Conditions
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Stroke, Cerebrovascular Accident, Hemiparesis

Intervention / Treatment
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* Device: AMES- Leg treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spastic hemiparesis At least 12 months post-stroke Can comfortably fit foot in treatment device Functioning proprioception Fugl-Meyer LE score >6 and <23 Minimal hemi-neglect Observable volitional movement of the ankle in either plantar- or dorsi-flexion Cognitively and behaviorally capable of complying with the regimen Exclusion Criteria: Fractures of treated limb resulting in loss of range of motion Spinal cord injury Deep venous thrombosis Peripheral nerve injury or neuropathy in the affected limb with motor disability Osteoarthritis limiting range of motion Uncontrolled high blood pressure/angina Exercise intolerant Skin condition not tolerant of device Progressive neurodegenerative disorder Uncontrolled seizure disorder Botox treatment within last 5 months Baclofen pump

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMES Leg treatment<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leg, Robotic device, AMES, Stroke, Cerebrovascular Accident, Rehabilitation