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Clinic-Based AMES Treatment of Stroke

Primary Purpose

Stroke, Cerebrovascular Accident

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Assisted movement and enhanced sensation
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Robotics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test treatment group

Arm Description

Device: Assisted movement and enhanced sensation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Timed 10-Meter Walk
Gait Assessment - Time
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.
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.
Strength Test
Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).
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.

Full Information

First Posted
February 18, 2009
Last Updated
November 23, 2016
Sponsor
Oregon Health and Science University
Collaborators
AMES Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00847704
Brief Title
Clinic-Based AMES Treatment of Stroke
Official Title
Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Funding not available.
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
AMES Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident
Keywords
Stroke, Rehabilitation, Robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test treatment group
Arm Type
Experimental
Arm Description
Device: Assisted movement and enhanced sensation
Intervention Type
Device
Intervention Name(s)
Assisted movement and enhanced sensation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment of the Lower Extremity
Description
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.
Time Frame
Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Secondary Outcome Measure Information:
Title
Timed 10-Meter Walk
Description
Gait Assessment - Time
Time Frame
Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Title
Stroke Impact Scale
Description
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.
Time Frame
Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Title
Spasticity (Modified Ashworth) Scale
Description
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.
Time Frame
Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Title
Strength Test
Description
Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).
Time Frame
First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
Title
Active Motion Test
Description
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.
Time Frame
First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J. Cordo, PhD
Organizational Affiliation
AMES Technology Inc./Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18645190
Citation
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.
Results Reference
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Clinic-Based AMES Treatment of Stroke

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