Clinic-Based AMES Treatment of Stroke

Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects

This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.

Study Overview

• Status: Terminated
• Conditions: Stroke; Cerebrovascular Accident
• Intervention / Treatment: Device: Assisted movement and enhanced sensation

Detailed Description

The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 12 months post-stroke
• Cognitively and behaviorally capable of complying with the regimen
• Functioning proprioception
• Less than 50% of normal strength in the affected ankle, but able to stand with or without assistive devices

Exclusion Criteria:

• Fractures of treated limb resulting in loss of range of motion
• Spinal cord injury
• Deep vein thrombosis
• Peripheral nerve injury or neuropathy in the limb affected with motor disability
• Osteoarthritis limiting range of motion
• Skin condition not tolerant of device
• Progressive neurodegenerative disorder
• Uncontrolled seizure disorder
• Botox treatment within the last 5 months
• Baclofen pump

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test treatment group; Device: Assisted movement and enhanced sensation	Device: Assisted movement and enhanced sensation; Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment of the Lower Extremity	Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed 10-Meter Walk	Gait Assessment - Time	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Stroke Impact Scale	The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows: Transformed Scale=[(Actual raw score-lowest possible raw score)/Possible raw score range]x100. Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning.	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Spasticity (Modified Ashworth) Scale	Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Strength Test	Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).	First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
Active Motion Test	Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.	First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: AMES Technology
• Investigators: Principal Investigator: Paul J. Cordo, PhD, AMES Technology Inc./Oregon Health and Science University

Publications and helpful links

General Publications

• Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.

Helpful Links

• Neurorehabilitation and Neural Repair Volume 23(1), 2009

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Robotics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: IRB 4005