StrokeAMESNCT01116544
Treatment of Chronic Stroke With AMES + EMG Biofeedback
A study testing AMES Therapy (assisted movement and enhanced sensation) in people with Stroke and Plegia, run by AMES Technology at 3 sites in United States.
Trial summary
The purpose of this study is to determine if individuals who had a stroke more than one year before entering the study and who remain unable to open their affected hand are better able to sense and move their affected arm after 10-15 weeks of treatment with a new robotic therapy device (the AMES device) and EMG… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- AMES Therapy (assisted movement and enhanced sensation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Sep 2007to 28 Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemispheric stroke (ischemic or hemorrhagic), cortical or sub-cortical, documented by either a CT or MRI scan and associated with residual upper extremity weakness.
- Chronic stroke, occurring ≥12 months prior to subject enrollment.
- Age 18-80 years old.
- Inability to move any of the fingers of the affected hand more than 5.0 cm into extension.
- Finger-and-wrist impedance ≤3 on the Modified Ashworth Scale.
- Measureable EMG (>2 x baseline) in the long finger extensor muscle during attempted hand opening or closing.
- Physically and cognitively capable of consenting to and complying with the protocol (based on exam by Study Physician).
- Subject must be physically capable of communicating informed consent or must be accompanied by legally authorized representative to provide informed consent.
Who cannot join
- Complete flaccidity of the affected arm.
- Significant upper extremity proprioceptive deficit (<70% correct detection of the direction of passive finger movement with eyes closed).
- Pathological neurological/physical conditions, other than stroke, impairing the function of the impaired arm or resulting in pain in the arm.
- Spinal cord injury, arthritis, or fractures of affected arm that have resulted in loss of range of motion.
- Peripheral nerve injury or neuropathy resulting in significant motor or sensory loss in the tested arm.
- 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.
Show all 19Show fewer
- Major active psychiatric disorder.
- Cognitively or behaviorally unable to follow instructions including severe apraxia; inability to understand verbal (English) directions, or inability to communicate adequately with study personnel.
- Size of arm incompatible with the AMES device (checked by placing the limb in the device).
- Severe contractures or decreased range of motion or skin condition that would prohibit comfortable positioning or tolerance of the device or the vibrators.
- Any progressive neurodegenerative disorder affecting the upper extremity 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 involving therapy to the impaired arm
- Planned initiation of or cessation of any kind of clinical therapy to the impaired limb just prior to or during the AMES treatment period.
- NIH Stroke Scale, following scores: Sensory Item score of >1; Neglect involving the affected limb score >1.
- Intent to receive Botox injections (5 months prior to or during enrollment), initiation of antispasmodic medication, or use of any other robotic (e.g., MANUS, Locomat) or electrical or vibratory stimulation device (e.g., Bioness) while participating in the AMES trial.
- Cognitively or behaviorally unable to follow instructions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Northwestern University
Chicago, Illinois, 60611
Oregon Health and Science University
Portland, Oregon, 97239
About this study
The purpose of this study is to determine if individuals who had a stroke more than one year before entering the study and who remain unable to open their affected hand are better able to sense and move their affected arm after 10-15 weeks of treatment with a new robotic therapy device (the AMES device) and EMG biofeedback.
Read the detailed description
Over the last 20 years, the discovery of cortical plasticity in the adult human brain has led to the development of new therapies to rehabilitate stroke survivors whose recovery of motor function has stalled with conventional therapeutic methodology. However, the efficacy of these new therapies appears to be limited to relatively high-functioning chronic stroke patients. A therapeutic approach that may be efficacious in restoring functional movement to low-functioning chronic stroke patients is "AMES," which stands for Assisted Movement with Enhanced Sensation. Despite the efficacy of AMES in restoring movement to low-functioning hemiparetic stroke patients, those with plegia at a joint tend not to recover movement in the plegic direction with AMES treatment or with other rehabilitation therapies. The objective of this study is to determine if AMES treatment in combination with biofeedback can be helpful in restoring functional movement to plegic stroke patients.
- Conditions
- Stroke, Plegia, Paresis, Cerebrovascular Accident
- Being tested
- AMES Therapy (assisted movement and enhanced sensation)
- Keywords
- AMES device, Cerebrovascular Accident, Chronic Stroke, Rehabilitation, Upper Extremity, Biofeedback
- Medical subject headings
- Stroke, Paralysis, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMES Therapy (assisted movement and enhanced sensation)Device
Also called Robotic
Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device. One group of subjects will receive AMES therapy only with joint torque biofeedback (without EMG feedback), and the other group will receive AMES therapy with EMG biofeedback. While all test subjects should attempt to open the hand when the grasp mechanism is opening and close the hand when the mechanism is closing, the biofeedback information provided to aid a subject will differ for the 2 subject groups.
| Study group | Role | What they receive |
|---|---|---|
| AMES therapy with EMG biofeedback | Experimental | The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. This study will examine whether AMES therapy combined with EMG biofeedback can restore hand opening to plegic stroke subjects. Receives: Device: AMES Therapy (assisted movement and enhanced sensation) |
| AMES therapy with Torque biofeedback | Experimental | The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of torque (force) the subject is able to generate in the hand during the movement. This study will examine whether AMES therapy combined with Torque biofeedback can restore hand opening to plegic stroke subjects. Receives: Device: AMES Therapy (assisted movement and enhanced sensation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Blocks Test
Measurement of the change in functional movement of the hand associated with 30 AMES training sessions.
Measured: Within a week of completing all training sessions.
Secondary outcomes (5)
Fugl-Meyer (UL) Assessment
Scale: Fugl-Meyer Assessment-Motor Function-Upper Limb Measurement of impairment in the upper limb based on tone, range-of-motion, and synergies. Total score in this study includes only the Upper Limb portion of the Motor Function subscale of the assessment, the Upper Limb subset having a scoring range of 0-66, with 0 representing no function and no visible reflexes (i.e., profound plegia) and 66 representing normal motor function.
Measured: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL)
Four of 8 possible subscales were used: Physical Problems, Mobility, Hand, and Daily Living, consisting of 26 total questions [scored from 1 (least impact) to 5 (most impact)]. The total (summed) raw score for all 4 sub-scales has a minimum of 26 and maximum of 130. The total raw score is then transformed:
[(Actual Raw Score-Lowest Possible Raw Score)/Possible Raw Score Range] X 100. The minimum transformed score is 0 and the maximum is 100.
Measured: Within a week of completing all training sessions.
Stroke Impact Scale (Stroke Recovery)
A separate section of the Stroke Impact Scale measures self-perception of stroke recovery. Stroke recovery is based on a scale of 0-100, with 0 representing no recovery and 100 representing full recovery.
Measured: Within a week of completing all training sessions.
Strength Test Flexion
Maximum squeezing (i.e., flexion) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.
Measured: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Strength Test Extension
Maximum opening (i.e., extension) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.
Measured: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study start21 Sep 2007
- Primary completion28 Feb 2011
- Study completion28 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AMES Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul J. Cordo, PhD, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116544
- Sponsor's protocol ID
- CT NS060192
- Acronym
- AMES
- Status last verified
- Oct 2019
- First submitted
- 3 May 2010
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cordo P, Wolf S, Lou JS, Bogey R, Stevenson M, Hayes J, Roth E. Treatment of severe hand impairment following stroke by combining assisted movement, muscle vibration, and biofeedback. J Neurol Phys Ther. 2013 Dec;37(4):194-203. doi: 10.1097/NPT.0000000000000023.
PubMed 24232364
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Stroke With AMES + EMG Biofeedback
- ClinicalTrials.gov ID
- NCT01116544
- Acronym / sponsor ID
- AMES / CT NS060192
- Conditions
- Stroke, Plegia, Paresis, Cerebrovascular Accident
- Keywords
- AMES device, Cerebrovascular Accident, Chronic Stroke, Rehabilitation, Upper Extremity, Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AMES TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University, Emory University, Northwestern University
- Study start
- 21 Sep 2007 (actual)
- Primary completion
- 28 Feb 2011 (actual)
- Study completion
- 28 Feb 2011 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 18 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if individuals who had a stroke more than one year before entering the study and who remain unable to open their affected hand are better able to sense and move their affected arm after 10-15 weeks of treatment with a new robotic therapy device (the AMES device) and EMG biofeedback.
Detailed description
Over the last 20 years, the discovery of cortical plasticity in the adult human brain has led to the development of new therapies to rehabilitate stroke survivors whose recovery of motor function has stalled with conventional therapeutic methodology. However, the efficacy of these new therapies appears to be limited to relatively high-functioning chronic stroke patients. A therapeutic approach that may be efficacious in restoring functional movement to low-functioning chronic stroke patients is "AMES," which stands for Assisted Movement with Enhanced Sensation. Despite the efficacy of AMES in restoring movement to low-functioning hemiparetic stroke patients, those with plegia at a joint tend not to recover movement in the plegic direction with AMES treatment or with other rehabilitation therapies. The objective of this study is to determine if AMES treatment in combination with biofeedback can be helpful in restoring functional movement to plegic stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMES therapy with EMG biofeedback | Experimental | Device: AMES Therapy (assisted movement and enhanced sensation)The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. This study will examine whether AMES therapy combined with EMG biofeedback can restore hand opening to plegic stroke subjects. |
| AMES therapy with Torque biofeedback | Experimental | Device: AMES Therapy (assisted movement and enhanced sensation)The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of torque (force) the subject is able to generate in the hand during the movement. This study will examine whether AMES therapy combined with Torque biofeedback can restore hand opening to plegic stroke subjects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hemispheric stroke (ischemic or hemorrhagic), cortical or sub-cortical, documented by either a CT or MRI scan and associated with residual upper extremity weakness.
- Chronic stroke, occurring ≥12 months prior to subject enrollment.
- Age 18-80 years old.
- Inability to move any of the fingers of the affected hand more than 5.0 cm into extension.
- Finger-and-wrist impedance ≤3 on the Modified Ashworth Scale.
Key exclusion criteria (19 listed)
- Complete flaccidity of the affected arm.
- Significant upper extremity proprioceptive deficit (<70% correct detection of the direction of passive finger movement with eyes closed).
- Pathological neurological/physical conditions, other than stroke, impairing the function of the impaired arm or resulting in pain in the arm.
- Spinal cord injury, arthritis, or fractures of affected arm that have resulted in loss of range of motion.
- Peripheral nerve injury or neuropathy resulting in significant motor or sensory loss in the tested arm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMES Therapy (assisted movement and enhanced sensation)Also: RoboticEach subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device. One group of subjects will receive AMES therapy only with joint torque biofeedback (without EMG feedback), and the other group will receive AMES therapy with EMG biofeedback. While all test subjects should attempt to open the hand when the grasp mechanism is opening and close the hand when the mechanism is closing, the biofeedback information provided to aid a subject will differ for the 2 subject groups. | Device | AMES therapy with EMG biofeedback, AMES therapy with Torque biofeedback |
Primary outcome
Box and Blocks Test
Time frame: Within a week of completing all training sessions.
Measurement of the change in functional movement of the hand associated with 30 AMES training sessions.
5 secondary outcomes
Fugl-Meyer (UL) Assessment
Time frame: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL)
Time frame: Within a week of completing all training sessions.
Stroke Impact Scale (Stroke Recovery)
Time frame: Within a week of completing all training sessions.
Strength Test Flexion
Time frame: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Strength Test Extension
Time frame: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24232364Cordo P, Wolf S, Lou JS, Bogey R, Stevenson M, Hayes J, Roth E. Treatment of severe hand impairment following stroke by combining assisted movement, muscle vibration, and biofeedback. J Neurol Phys Ther. 2013 Dec;37(4):194-203. doi: 10.1097/NPT.0000000000000023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J. Cordo, PhD study director
Oregon Health and Science University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMES Therapy (assisted movement and enhanced sensation) in people with Stroke and Plegia, run by AMES Technology at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Blocks Test (time frame: Within a week of completing all training sessions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01116544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.