AMES Treatment of the Impaired Leg in Chronic Stroke Patients (AMES)

December 7, 2016 updated by: AMES Technology
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University/Rehabilitation Institute of Chicago
    • Oregon
      • Portland, Oregon, United States, 97006
        • Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 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.
Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Modified Ashworth Scale
Time Frame: 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.
Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Dynamic Balance/Weight Distribution
Time Frame: 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.
Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Ankle Strength
Time Frame: Prior to each treatment session,
Measurement of three attempts of dorsiflexion and three attempts of plantarflexion.
Prior to each treatment session,
Passive Motion Test
Time Frame: Prior to each treatment session
Measures the peak resistance in the affected ankle.
Prior to each treatment session
Active Range of Motion Test
Time Frame: Prior to each treatment session
A joint tracking task guided by visual feedback on a computer screen.
Prior to each treatment session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AMES Technology

Collaborators

Northwestern University
National Institute of Neurological Disorders and Stroke (NINDS)
Oregon Health and Science University
Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: Elliot Roth, MD, Northwestern University/Rehabilitation Institute of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (ESTIMATE)

June 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7034
  • R44NS060192-03 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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