AMES Treatment of the Impaired Leg in Chronic Stroke Patients

Phase 1

• Conditions: Stroke; Cerebrovascular Accident; Hemiparesis
• Interventions: Device: AMES- Leg treatment

• Registration Number: NCT01378637
• Lead Sponsor: AMES Technology

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).

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-22
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Last Update Submitted: 2016-12-07
• Last Update Posted: 2016-12-08
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMES Leg treatment	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Northwestern University/Rehabilitation Institute of Chicago; 🇺🇸 Chicago, Illinois, United States