search
Back to results

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

Primary Purpose

Stroke, Cerebrovascular Accident, Hemiparesis

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMES- Leg treatment
Sponsored by
AMES Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Leg, Robotic device, AMES, Stroke, Cerebrovascular Accident, Rehabilitation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University/Rehabilitation Institute of Chicago
  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMES Leg treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Fugl-Meyer Motor Assessment of the Lower Affected Extremity

Secondary Outcome Measures

Gait Assessment
The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test.
Modified Ashworth Scale
Measurement of spasticity in the ankle joint.
Dynamic Balance/Weight Distribution
Measure the subject's right-left weight distribution and dynamic balance control.
Ankle Strength
Measurement of three attempts of dorsiflexion and three attempts of plantarflexion.
Passive Motion Test
Measures the peak resistance in the affected ankle.
Active Range of Motion Test
A joint tracking task guided by visual feedback on a computer screen.

Full Information

First Posted
February 18, 2011
Last Updated
December 7, 2016
Sponsor
AMES Technology
Collaborators
Oregon Health and Science University, Northwestern University, Shirley Ryan AbilityLab, National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT01378637
Brief Title
AMES Treatment of the Impaired Leg in Chronic Stroke Patients
Acronym
AMES
Official Title
AMES Treatment of the Impaired Leg in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AMES Technology
Collaborators
Oregon Health and Science University, Northwestern University, Shirley Ryan AbilityLab, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident, Hemiparesis
Keywords
Leg, Robotic device, AMES, Stroke, Cerebrovascular Accident, Rehabilitation

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
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMES Leg treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AMES- Leg treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Gait Assessment
Description
The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test.
Time Frame
Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Title
Modified Ashworth Scale
Description
Measurement of spasticity in the ankle joint.
Time Frame
Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Title
Dynamic Balance/Weight Distribution
Description
Measure the subject's right-left weight distribution and dynamic balance control.
Time Frame
Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Title
Ankle Strength
Description
Measurement of three attempts of dorsiflexion and three attempts of plantarflexion.
Time Frame
Prior to each treatment session,
Title
Passive Motion Test
Description
Measures the peak resistance in the affected ankle.
Time Frame
Prior to each treatment session
Title
Active Range of Motion Test
Description
A joint tracking task guided by visual feedback on a computer screen.
Time Frame
Prior to each treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Oken, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elliot Roth, MD
Organizational Affiliation
Northwestern University/Rehabilitation Institute of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University/Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97006
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

AMES Treatment of the Impaired Leg in Chronic Stroke Patients

We'll reach out to this number within 24 hrs