Sub-Acute Stroke Rehabilitation With AMES
AMES
1 other identifier
interventional
83
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 27, 2007
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2011
CompletedResults Posted
Study results publicly available
October 3, 2022
CompletedOctober 3, 2022
February 1, 2022
3.5 years
December 27, 2007
February 6, 2022
September 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Secondary Outcomes (9)
Stroke Impact Scale
Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Rancho Los Amigos Functional Test
Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Spasticity (Modified Ashworth) Scale
Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Active Motion Test Grasp
Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Active Motion Wrist
Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
- +4 more secondary outcomes
Study Arms (3)
Test-Phase 1
EXPERIMENTALThe 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.
Control-Phase 1
SHAM COMPARATOREighteen 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.
Crossover-Phase 2
ACTIVE COMPARATOROriginal 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.-
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AMES Technologylead
- Northwest Medical Rehabilitation, Spokane, WAcollaborator
- Emory Universitycollaborator
- University of California, San Franciscocollaborator
- Shirley Ryan AbilityLabcollaborator
- Eisenhower Medical Centercollaborator
- Legacy Health Systemcollaborator
Study Sites (5)
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
UCSF School of Medicine- Physical Therapy and Rehabilitation
San Francisco, California, 94123, United States
Emory University Dept of Rehabilitation Medicine/School of Medicine
Atlanta, Georgia, 30322, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
NW Medical Rehabilitation
Spokane, Washington, 99202, United States
Related Publications (1)
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.
PMID: 35067125DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Paul Cordo
- Organization
- AMES Technology, Inc.
Study Officials
- STUDY DIRECTOR
Paul J. Cordo, PhD
AMES Technology Inc./ Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2007
First Posted
February 6, 2008
Study Start
September 1, 2007
Primary Completion
February 28, 2011
Study Completion
February 28, 2011
Last Updated
October 3, 2022
Results First Posted
October 3, 2022
Record last verified: 2022-02