AMES Treatment of the Impaired Leg in Chronic Stroke Patients
This study is currently recruiting participants.
Verified November 2012 by AMES Technology
Sponsor:
AMES Technology
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: November 29, 2012
Last verified: November 2012
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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 2013 |
| Estimated Primary Completion Date: | June 2013 (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: | Jau-Shin Lou, 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: | November 29, 2012 |
| 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 May 16, 2013