AMES Treatment of the Impaired Leg in Chronic Stroke Patients

AMES Technology

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cerebrovascular Accident; Stroke; Hemiparesis

Treatments: Device: AMES- Leg treatment

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01378637

7034

R44NS060192-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

AMES Leg treatment

Experimental group

Description:

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.

Treatment:

Device: AMES- Leg treatment