AMES Treatment of the Impaired Leg in Chronic Stroke Patients

This study is currently recruiting participants.
Verified January 2014 by AMES Technology
Sponsor:
Collaborators:
Oregon Health and Science University
Northwestern University
Rehabilitation Institute of Chicago
Information provided by (Responsible Party):
AMES Technology
ClinicalTrials.gov Identifier:
NCT01378637
First received: February 18, 2011
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Stroke
Cerebrovascular Accident
Hemiparesis
Device: AMES- Leg therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AMES Treatment of the Impaired Leg in Chronic Stroke Patients

Resource links provided by NLM:


Further study details as provided by AMES Technology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gait Assessment [ Time Frame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments ] [ Designated as safety issue: No ]
    The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test.

  • 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 ] [ Designated as safety issue: No ]
    Measurement of spasticity in the ankle joint.

  • 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 ] [ Designated as safety issue: No ]
    Measure the subject's right-left weight distribution and dynamic balance control.

  • Ankle Strength [ Time Frame: Prior to each treatment session, ] [ Designated as safety issue: No ]
    Measurement of three attempts of dorsiflexion and three attempts of plantarflexion.

  • Passive Motion Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
    Measures the peak resistance in the affected ankle.

  • Active Range of Motion Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
    A joint tracking task guided by visual feedback on a computer screen.


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 therapy
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378637

Contacts
Contact: Paul J. Cordo, PhD 503-418-2520 cordop@ohsu.edu
Contact: Linda D. Cordo, RN MSN 503-223-3442 cordol@ohsu.edu

Locations
United States, Illinois
Northwestern University/Rehabilitation Institute of Chicago Completed
Chicago, Illinois, United States, 60611
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97006
Contact: Linda D Cordo, BSN, MSN    503-223-3442    cordol@ohsu.edu   
Principal Investigator: Jau-Shin Lou, MD, PhD         
Principal Investigator: Paul J Cordo, PhD         
Sponsors and Collaborators
AMES Technology
Oregon Health and Science University
Northwestern University
Rehabilitation Institute of Chicago
Investigators
Principal Investigator: Barry Oken, MD Oregon Health and Science University
Principal Investigator: Elliot Roth, MD Northwestern University/Rehabilitation Institute of Chicago
  More Information

No publications provided

Responsible Party: AMES Technology
ClinicalTrials.gov Identifier: NCT01378637     History of Changes
Other Study ID Numbers: 7034, R44NS060192-03
Study First Received: February 18, 2011
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by AMES Technology:
Leg
Robotic device
AMES
Stroke
Cerebrovascular Accident
Rehabilitation

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Paresis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014