Back to resultsSub-Acute Stroke Rehabilitation With AMES (AMES)
Primary Purpose
Cerebrovascular Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMES device (test)
AMES device (sham)
AMES device (crossover)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Stroke focused on measuring Sub-acute care, Robotics
Eligibility Criteria
Inclusion Criteria:
- Hemispheric stroke (ischemic or hemorrhagic), cortical or sub-cortical, documented by either a CT or MRI scan and associated with residual weakness in the arm and/or leg.
- First time ever stroke or previous stroke with complete resolution of motor deficit, occurring ≤4 months prior to subject enrollment.
- Age 18-80 years old.
- Moderate to severe lower-extremity paresis (defined as a leg motor Fugl-Meyer score of ≥6 and ≤22 out of a possible 34.
- Moderate to severe upper-extremity paresis (defined as an arm motor Fugl-Meyer score of ≥6 and ≤43 out of a possible 66.
- Visible voluntary movement of the ankle in at least one direction: dorsiflexion or plantarflexion for the ankle and flexion or extension for the hand.
- At least partially functioning proprioception from the paretic arm or leg-capable of correctly identifying, ≥70% of the time, the direction of passive joint rotation (i.e., flexion-extension) with eyes closed.
- Physically and cognitively capable of consenting to and complying with the protocol.
- Score of <19 out of 63 on the 21-question version of the Beck Depression Inventory.
- Subject or legally authorized representative must be capable of providing informed consent.-
Exclusion Criteria:
- Complete flaccidity of the hand, wrist, and ankle.
- Pathological neurological/physical conditions, other than stroke, impairing the function of the impaired arm or leg or resulting in pain in either the arm or leg.
- Spinal cord injury, arthritis, or fractures of affected limbs that have resulted in loss of range of motion.
- Peripheral nerve injury or neuropathy resulting in significant motor or sensory loss in the limb being considered for testing.
- Cardiopulmonary compromise including but not limited to uncontrolled hypertension or angina, deep vein thrombosis, decompensated congestive heart failure, myocardial infarction, heart irregularities, or exercise intolerance.
- Major active psychiatric disorder.
- Severe apraxia; inability to understand verbal (English) directions; or inability to communicate adequately with study personnel.
- Size of arm or leg incompatible with the AMES device.
- Severe contractures or decreased range of motion that would prohibit comfortable positioning or tolerance of the device
- Skin condition not able to tolerate use of the AMES device.
- Any progressive neurodegenerative disorder affecting the motor system.
- Uncontrolled seizure disorder.
- Current abuse of alcohol or drugs.
- Terminal illness with anticipated survival of <12 months.
- Current or planned concurrent participation in another study or clinical trial.
- NIH Stroke Scale, following scores: Item 1a > 0; Item 1c > 0; Item 2 > 0; Item 3 > 0; Item 9 > 2; Item 10 > 1; Item 11 > 1 (based on exam by Study Physician).
- Intent to receive Botox injections, initiation of antispasmodic medication, or use any other robotic (e.g., MANUS, Locomat) or stimulation device (e.g., Bioness) while participating in the AMES trial.
Sites / Locations
- Eisenhower Medical Center
- UCSF School of Medicine- Physical Therapy and Rehabilitation
- Emory University Dept of Rehabilitation Medicine/School of Medicine
- Rehabilitation Institute of Chicago
- NW Medical Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
Test-Phase 1
Control-Phase 1
Crossover-Phase 2
Arm Description
The Test Group receives 18 half-hour AMES (Assisted Movement with Enhanced Sensation) treatments with the AMES device (Test) in which the hand or wrist is moved, and the subject assists the motion while vibration (60 pulses/sec) is applied to the lengthening muscle. Sessions to be scheduled preferably 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
Eighteen treatment sessions for each qualifying subject limb using the AMES device (sham) programed to provide placebo therapy. Each treatment session consisting of 30 minutes of sham therapy. Sessions to be scheduled preferably 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
Original Control Group receives 18 half-hour crossover treatments with the AMES device (Crossover) in which the hand or wrist is moved, and the subject assists the motion while vibration (60 pulses/sec) is applied to the lengthening muscle. Sessions to be scheduled preferably 2 to 3 times per week with each session one-half hour in length.
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment Upper Limb Portion
Comprehensive measure of upper limb impairment; minimum score = 0, maximum score = 66; higher score means better outcome. Outcome measure represents the difference between post-treatment and baseline (i.e., change score). Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Secondary Outcome Measures
Stroke Impact Scale
Activities of daily living questionnaire for stroke patients. Minimum overall score = 0, maximum overall score = 800. Higher scores mean better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Rancho Los Amigos Functional Test
Upper limb functional movement. Outcome measure indicates how many of 17 functional tasks could be completed. Minimum score = 0, maximum score = 17. Higher number means better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Spasticity (Modified Ashworth) Scale
Joint impedance of the fingers+wrist combined and that of the elbow. Outcome measure consists of the sum of 4 scores: (1) hand/wrist flexion, (2) hand/wrist extension, (3) elbow flexion, (4) elbow extension. Minimum value = 0, maximum value = 20. Higher score means worse outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Active Motion Test Grasp
Ability to track a moving target with active grasp extension and flexion, measured as the total time in the target, in seconds. Outcome measure represents the change score from baseline to post-treatment. Minimum score = 0, maximum score = 40 s. Higher scores indicate better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Active Motion Wrist
Ability to track a moving target with active wrist extension and flexion, measured as the total time in the target, in seconds. Outcome measure represents the change score from baseline to post-treatment. Minimum score = 0, maximum score = 40 s. Higher scores indicate better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Strength Grasp Flexion
Isometric grasp flexion strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Strength Grasp Extension
Isometric grasp extension strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Strength Wrist Flexion
Isometric wrist flexion strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Strength Wrist Extension
Isometric wrist extension strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Full Information
NCT ID
NCT00609115
First Posted
December 27, 2007
Last Updated
September 3, 2022
Sponsor
AMES Technology
Collaborators
Northwest Medical Rehabilitation, Spokane, WA, Emory University, University of California, San Francisco, Shirley Ryan AbilityLab, Eisenhower Medical Center, Legacy Health System
1. Study Identification
Unique Protocol Identification Number
NCT00609115
Brief Title
Sub-Acute Stroke Rehabilitation With AMES
Acronym
AMES
Official Title
Sub-Acute Stroke Rehabilitation With Assisted Movement With Enhanced Sensation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2007 (Actual)
Primary Completion Date
February 28, 2011 (Actual)
Study Completion Date
February 28, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AMES Technology
Collaborators
Northwest Medical Rehabilitation, Spokane, WA, Emory University, University of California, San Francisco, Shirley Ryan AbilityLab, Eisenhower Medical Center, Legacy Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The AMES device is designed to produce functional cortical changes by:(1) assisting the subject as he/she attempts to move the limb (assisted movement) and (2) enhancing movement sensation by vibrating the muscles during movement (enhanced sensation). The primary hypothesis is that the combination of assisted movement and enhanced sensation from muscle vibration can increase the amount of motor recovery in individuals disabled by a stroke.
Detailed Description
Approximately 700,000 U.S. citizens have a stroke each year with about half ending up with significant motor disabilities. There are an estimated 5 million stroke survivors in the U.S., making strokes the leading cause of long-term disability in the U.S.. Existing rehabilitation therapies have not been effective in returning all stroke survivors to full motor recovery.
The AMES device was designed to be able to provide therapy for the hand (fingers/wrist). In this 18 treatment sessions, double-blinded, control study, AMES therapy will be provided in addition to the usual physician-ordered rehabilitation during the sub-acute period following a stroke. Those control subject who complete the Phase 1 placebo sessions will have the opportunity to cross-over to participate in a AMES treatment group for a Phase 2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Stroke
Keywords
Sub-acute care, Robotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single crossover for only the control group participants from the controlled part of the study.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test-Phase 1
Arm Type
Experimental
Arm Description
The Test Group receives 18 half-hour AMES (Assisted Movement with Enhanced Sensation) treatments with the AMES device (Test) in which the hand or wrist is moved, and the subject assists the motion while vibration (60 pulses/sec) is applied to the lengthening muscle. Sessions to be scheduled preferably 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
Arm Title
Control-Phase 1
Arm Type
Sham Comparator
Arm Description
Eighteen treatment sessions for each qualifying subject limb using the AMES device (sham) programed to provide placebo therapy. Each treatment session consisting of 30 minutes of sham therapy. Sessions to be scheduled preferably 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
Arm Title
Crossover-Phase 2
Arm Type
Active Comparator
Arm Description
Original Control Group receives 18 half-hour crossover treatments with the AMES device (Crossover) in which the hand or wrist is moved, and the subject assists the motion while vibration (60 pulses/sec) is applied to the lengthening muscle. Sessions to be scheduled preferably 2 to 3 times per week with each session one-half hour in length.
Intervention Type
Device
Intervention Name(s)
AMES device (test)
Intervention Description
Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
Intervention Type
Device
Intervention Name(s)
AMES device (sham)
Intervention Description
Eighteen treatment sessions for each qualifying subject limb using the AMES device (sham) in which the limb is moved, but no active assistance is provided by the subject and the vibration is delivered at a very low frequency to the shortening (i.e., rather than lengthening) muscle. Each treatment session to provide thirty minutes of the placebo form of AMES therapy.
Intervention Type
Device
Intervention Name(s)
AMES device (crossover)
Intervention Description
Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed as soon as possible after the completion of Arm C-1 Sham Comparator.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment Upper Limb Portion
Description
Comprehensive measure of upper limb impairment; minimum score = 0, maximum score = 66; higher score means better outcome. Outcome measure represents the difference between post-treatment and baseline (i.e., change score). Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time Frame
Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Secondary Outcome Measure Information:
Title
Stroke Impact Scale
Description
Activities of daily living questionnaire for stroke patients. Minimum overall score = 0, maximum overall score = 800. Higher scores mean better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time Frame
Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Title
Rancho Los Amigos Functional Test
Description
Upper limb functional movement. Outcome measure indicates how many of 17 functional tasks could be completed. Minimum score = 0, maximum score = 17. Higher number means better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time Frame
Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Title
Spasticity (Modified Ashworth) Scale
Description
Joint impedance of the fingers+wrist combined and that of the elbow. Outcome measure consists of the sum of 4 scores: (1) hand/wrist flexion, (2) hand/wrist extension, (3) elbow flexion, (4) elbow extension. Minimum value = 0, maximum value = 20. Higher score means worse outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time Frame
Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Title
Active Motion Test Grasp
Description
Ability to track a moving target with active grasp extension and flexion, measured as the total time in the target, in seconds. Outcome measure represents the change score from baseline to post-treatment. Minimum score = 0, maximum score = 40 s. Higher scores indicate better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time Frame
Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Title
Active Motion Wrist
Description
Ability to track a moving target with active wrist extension and flexion, measured as the total time in the target, in seconds. Outcome measure represents the change score from baseline to post-treatment. Minimum score = 0, maximum score = 40 s. Higher scores indicate better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time Frame
Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Title
Strength Grasp Flexion
Description
Isometric grasp flexion strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time Frame
Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Title
Strength Grasp Extension
Description
Isometric grasp extension strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time Frame
Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Title
Strength Wrist Flexion
Description
Isometric wrist flexion strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time Frame
Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Title
Strength Wrist Extension
Description
Isometric wrist extension strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time Frame
Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hemispheric stroke (ischemic or hemorrhagic), cortical or sub-cortical, documented by either a CT or MRI scan and associated with residual weakness in the arm and/or leg.
First time ever stroke or previous stroke with complete resolution of motor deficit, occurring ≤4 months prior to subject enrollment.
Age 18-80 years old.
Moderate to severe lower-extremity paresis (defined as a leg motor Fugl-Meyer score of ≥6 and ≤22 out of a possible 34.
Moderate to severe upper-extremity paresis (defined as an arm motor Fugl-Meyer score of ≥6 and ≤43 out of a possible 66.
Visible voluntary movement of the ankle in at least one direction: dorsiflexion or plantarflexion for the ankle and flexion or extension for the hand.
At least partially functioning proprioception from the paretic arm or leg-capable of correctly identifying, ≥70% of the time, the direction of passive joint rotation (i.e., flexion-extension) with eyes closed.
Physically and cognitively capable of consenting to and complying with the protocol.
Score of <19 out of 63 on the 21-question version of the Beck Depression Inventory.
Subject or legally authorized representative must be capable of providing informed consent.-
Exclusion Criteria:
Complete flaccidity of the hand, wrist, and ankle.
Pathological neurological/physical conditions, other than stroke, impairing the function of the impaired arm or leg or resulting in pain in either the arm or leg.
Spinal cord injury, arthritis, or fractures of affected limbs that have resulted in loss of range of motion.
Peripheral nerve injury or neuropathy resulting in significant motor or sensory loss in the limb being considered for testing.
Cardiopulmonary compromise including but not limited to uncontrolled hypertension or angina, deep vein thrombosis, decompensated congestive heart failure, myocardial infarction, heart irregularities, or exercise intolerance.
Major active psychiatric disorder.
Severe apraxia; inability to understand verbal (English) directions; or inability to communicate adequately with study personnel.
Size of arm or leg incompatible with the AMES device.
Severe contractures or decreased range of motion that would prohibit comfortable positioning or tolerance of the device
Skin condition not able to tolerate use of the AMES device.
Any progressive neurodegenerative disorder affecting the motor system.
Uncontrolled seizure disorder.
Current abuse of alcohol or drugs.
Terminal illness with anticipated survival of <12 months.
Current or planned concurrent participation in another study or clinical trial.
NIH Stroke Scale, following scores: Item 1a > 0; Item 1c > 0; Item 2 > 0; Item 3 > 0; Item 9 > 2; Item 10 > 1; Item 11 > 1 (based on exam by Study Physician).
Intent to receive Botox injections, initiation of antispasmodic medication, or use any other robotic (e.g., MANUS, Locomat) or stimulation device (e.g., Bioness) while participating in the AMES trial.
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
Study Director
Facility Information:
Facility Name
Eisenhower Medical Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
UCSF School of Medicine- Physical Therapy and Rehabilitation
City
San Francisco
State/Province
California
ZIP/Postal Code
94123
Country
United States
Facility Name
Emory University Dept of Rehabilitation Medicine/School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NW Medical Rehabilitation
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35067125
Citation
Cordo P, Wolf S, Rymer WZ, Byl N, Stanek K, Hayes JR. Assisted Movement With Proprioceptive Stimulation Augments Recovery From Moderate-To-Severe Upper Limb Impairment During Subacute Stroke Period: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2022 Mar;36(3):239-250. doi: 10.1177/15459683211063159. Epub 2022 Jan 24.
Results Reference
derived
Links:
URL
http://amesdevices.com
Description
Study sponsor AMES Technology, Inc. website
Learn more about this trial
Sub-Acute Stroke Rehabilitation With AMES
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