StrokePhase 1AMESNCT01934439
AMES Treatment of the Proximal Arm in Chronic Stroke
A Phase 1 study testing 30 PAAD treatments in people with Stroke and Cerebrovascular Accident, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected by a chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Cerebrovascular Accident
- What is being tested?
- 30 PAAD treatments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or Hemorrhagic stroke affecting the right arm
- One year or longer since stroke
- Severe impairment of right arm with a baseline upper extremity Fugl-Meyer score between 8-24
- Right elbow and shoulder spasticity (Ashworth score ≤3)
- Right shoulder abduction-elbow flexion dyssynergia
Who cannot join
- Exercise intolerance
- Co-morbidities limiting arm movement (e.g. shoulder subluxation)
- Chronic pain
- Cognitive dysfunction preventing compliance with instructions
- Participation in other ongoing research studies
- Plans to initiate or discontinue any physical/occupational therapy during the period of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University West Campus
Beaverton, Oregon, 97006
About this study
Official title: AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients
Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected by a chronic stroke.
Read the detailed description
This study seeks to determine whether 30 treatments with AMES, to the proximal affected arm of subjects with chronic stroke, will improve subjects' proximal arm active range-of-motion. We hypothesize that the combination of assisted movement, torque biofeedback, and muscle vibration will reduce impairment (i.e., increase strength and range-of-motion; decrease inappropriate patterns of muscle contraction) and, thereby, lead to more accurate reaching with the proximal arm.
- Conditions
- Stroke, Cerebrovascular Accident
- Being tested
- 30 PAAD treatments
- Keywords
- Stroke, Rehabilitation, Dyssynergia, Robotics, AMES, Cerebrovascular Accident
- Medical subject headings
- Stroke, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 PAAD treatmentsDevice
Subjects will don a shirt with pockets at the elbow and shoulder in each of which a muscle vibrator is located. The subject will then place the affected arm in the PAAD. The PAAD will range the affected arm, at the shoulder in the adduction-abduction direction, and at the elbow in the flexion-extension direction. The subject will assist volitionally this motion, and visual feedback of the level of their assistive torque will be provided along with a target torque level. The muscle vibrators will alternate from one side of each of the 2 joints to the other as the motion reverses, vibration always being applied to the lengthening muscles. This treatment will last 30 min in each session.
| Study group | Role | What they receive |
|---|---|---|
| PAAD (Proximal Arm AMES Device)Treatments | Experimental | The PAAD flexes and extends the elbow, and it abducts and adducts the shoulder, where "abduction" is away from the side of the body, and "adduction" is towards it. Elbow extension occurs simultaneously with shoulder abduction, and elbow flexion occurs simultaneously with shoulder adduction. At the same time as the movements, vibrators are utilized to activate muscle spindle Ia receptors in the muscles of the arm to exaggerate the perception of movement. Receives: Device: 30 PAAD treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment - Upper Extremity
Measured: Baseline and change from baseline at 0 and 3 months post completion
Secondary outcomes (2)
Ashworth Spasticity Scale
Measured: Baseline and change from baseline at 0 and 3 months post completion
Modified Wolf Motor Test
Measured: Baseline and change from baseline at 0 and 3 months post completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Loss of funding; could not complete building the testing device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul J. Cordo, Oregon Health and Science University
- Investigators
- Barry Oken, MD, Principal investigator, Oregon Health and Science UniversityPaul J Cordo, Ph.D, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934439
- Sponsor's protocol ID
- IRB00009262
- Other IDs
- OCF9009196
- Acronym
- AMES
- Status last verified
- Mar 2019
- First submitted
- 26 Aug 2013
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.
PubMed 18645190
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients
- ClinicalTrials.gov ID
- NCT01934439
- Acronym / sponsor ID
- AMES / IRB00009262
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- Stroke, Rehabilitation, Dyssynergia, Robotics, AMES, Cerebrovascular Accident
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Loss of funding; could not complete building the testing device.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected by a chronic stroke.
Detailed description
This study seeks to determine whether 30 treatments with AMES, to the proximal affected arm of subjects with chronic stroke, will improve subjects' proximal arm active range-of-motion. We hypothesize that the combination of assisted movement, torque biofeedback, and muscle vibration will reduce impairment (i.e., increase strength and range-of-motion; decrease inappropriate patterns of muscle contraction) and, thereby, lead to more accurate reaching with the proximal arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAAD (Proximal Arm AMES Device)Treatments | Experimental | Device: 30 PAAD treatmentsThe PAAD flexes and extends the elbow, and it abducts and adducts the shoulder, where "abduction" is away from the side of the body, and "adduction" is towards it. Elbow extension occurs simultaneously with shoulder abduction, and elbow flexion occurs simultaneously with shoulder adduction. At the same time as the movements, vibrators are utilized to activate muscle spindle Ia receptors in the muscles of the arm to exaggerate the perception of movement. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ischemic or Hemorrhagic stroke affecting the right arm
- One year or longer since stroke
- Severe impairment of right arm with a baseline upper extremity Fugl-Meyer score between 8-24
- Right elbow and shoulder spasticity (Ashworth score ≤3)
- Right shoulder abduction-elbow flexion dyssynergia
Key exclusion criteria (6 listed)
- Exercise intolerance
- Co-morbidities limiting arm movement (e.g. shoulder subluxation)
- Chronic pain
- Cognitive dysfunction preventing compliance with instructions
- Participation in other ongoing research studies
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 |
|---|---|---|
| 30 PAAD treatmentsSubjects will don a shirt with pockets at the elbow and shoulder in each of which a muscle vibrator is located. The subject will then place the affected arm in the PAAD. The PAAD will range the affected arm, at the shoulder in the adduction-abduction direction, and at the elbow in the flexion-extension direction. The subject will assist volitionally this motion, and visual feedback of the level of their assistive torque will be provided along with a target torque level. The muscle vibrators will alternate from one side of each of the 2 joints to the other as the motion reverses, vibration always being applied to the lengthening muscles. This treatment will last 30 min in each session. | Device | PAAD (Proximal Arm AMES Device)Treatments |
Primary outcome
Fugl-Meyer Assessment - Upper Extremity
Time frame: Baseline and change from baseline at 0 and 3 months post completion
2 secondary outcomes
Ashworth Spasticity Scale
Time frame: Baseline and change from baseline at 0 and 3 months post completion
Modified Wolf Motor Test
Time frame: Baseline and change from baseline at 0 and 3 months post completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Background: PubMed 18645190Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.
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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.
Barry Oken, MD principal investigator
Oregon Health and Science University
Paul J Cordo, Ph.D study director
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 30 PAAD treatments in people with Stroke and Cerebrovascular Accident, run by Oregon Health and Science University at 1 site 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Fugl-Meyer Assessment - Upper Extremity (time frame: Baseline and change from baseline at 0 and 3 months post completion). 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 NCT01934439, 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 29 Mar 2019.