Clinic-Based AMES Treatment of Stroke

Phase 1

Terminated

Conditions: Stroke
Cerebrovascular Accident

Interventions: Device: Assisted movement and enhanced sensation

Registration Number: NCT00847704

Lead Sponsor: Oregon Health and Science University

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

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test treatment group	Assisted movement and enhanced sensation	Device: Assisted movement and enhanced sensation

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment of the Lower Extremity	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Stroke Impact Scale	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up	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.
Spasticity (Modified Ashworth) Scale	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up	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.
Timed 10-Meter Walk	Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up	Gait Assessment - Time
Strength Test	First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)	Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).
Active Motion Test	First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)	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.