AMES Treatment of the Impaired Leg in Chronic Stroke Patients

AMES Technology22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Cerebrovascular Accident Hemiparesis

Interventions

AMES- Leg treatmentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

Northwestern University/Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Oregon Health and Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Fugl-Meyer Motor Assessment of the Lower Affected Extremity

Time frame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments

Secondary Outcomes

Gait Assessment

The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Prior to each treatment session,

Passive Motion Test

Measures the peak resistance in the affected ankle.

Time frame: Prior to each treatment session

Active Range of Motion Test

A joint tracking task guided by visual feedback on a computer screen.

Time frame: Prior to each treatment session

Data from ClinicalTrials.gov

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