StrokePhase 1/2NCT00847704
Clinic-Based AMES Treatment of Stroke
A Phase 1/2 study testing Assisted movement and enhanced sensation in people with Stroke and Cerebrovascular Accident, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait. 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?
- Assisted movement and enhanced sensation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Nov 2009
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 12 months post-stroke
- Cognitively and behaviorally capable of complying with the regimen
- Functioning proprioception
- Less than 50% of normal strength in the affected ankle, but able to stand with or without assistive devices
Who cannot join
- Fractures of treated limb resulting in loss of range of motion
- Spinal cord injury
- Deep vein thrombosis
- Peripheral nerve injury or neuropathy in the limb affected with motor disability
- Osteoarthritis limiting range of motion
- Skin condition not tolerant of device
Show all 10Show fewer
- Progressive neurodegenerative disorder
- Uncontrolled seizure disorder
- Botox treatment within the last 5 months
- Baclofen pump
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects
This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.
Read the detailed description
The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.
- Conditions
- Stroke, Cerebrovascular Accident
- Being tested
- Assisted movement and enhanced sensation
- Keywords
- Stroke, Rehabilitation, Robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted movement and enhanced sensationDevice
Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Test treatment group | Experimental | Device: Assisted movement and enhanced sensation Receives: Device: Assisted movement and enhanced sensation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of the Lower Extremity
Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.
Measured: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Secondary outcomes (5)
Timed 10-Meter Walk
Gait Assessment - Time
Measured: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Stroke Impact Scale
The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows:
Transformed Scale=[(Actual raw score-lowest possible raw score)/Possible raw score range]x100.
Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning.
Measured: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Spasticity (Modified Ashworth) Scale
Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.
Measured: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Strength Test
Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).
Measured: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
Active Motion Test
Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.
Measured: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Funding not available.
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- AMES Technology
- Responsible party
- Principal investigator, Paul J. Cordo, Oregon Health and Science University
- Investigators
- Paul J. Cordo, PhD, Principal investigator, AMES Technology Inc./Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847704
- Sponsor's protocol ID
- IRB 4005
- Status last verified
- Nov 2016
- First submitted
- 18 Feb 2009
- Last updated
- 23 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- 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 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects
- ClinicalTrials.gov ID
- NCT00847704
- Acronym / sponsor ID
- IRB 4005
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- Stroke, Rehabilitation, Robotics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding not available.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- AMES Technology
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 23 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.
Detailed description
The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test treatment group | Experimental | Device: Assisted movement and enhanced sensationDevice: Assisted movement and enhanced sensation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 12 months post-stroke
- Cognitively and behaviorally capable of complying with the regimen
- Functioning proprioception
- Less than 50% of normal strength in the affected ankle, but able to stand with or without assistive devices
Key exclusion criteria (10 listed)
- Fractures of treated limb resulting in loss of range of motion
- Spinal cord injury
- Deep vein thrombosis
- Peripheral nerve injury or neuropathy in the limb affected with motor disability
- Osteoarthritis limiting range of motion
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 |
|---|---|---|
| Assisted movement and enhanced sensationEach subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session. | Device | Test treatment group |
Primary outcome
Fugl-Meyer Assessment of the Lower Extremity
Time frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.
5 secondary outcomes
Timed 10-Meter Walk
Time frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Stroke Impact Scale
Time frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Spasticity (Modified Ashworth) Scale
Time frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Strength Test
Time frame: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
Active Motion Test
Time frame: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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 principal investigator
AMES Technology Inc./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 1/2 study testing Assisted movement and enhanced sensation 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 23 Jan 2017. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2017). 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?
Fugl-Meyer Assessment of the Lower Extremity (time frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up). 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 NCT00847704, 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 23 Jan 2017.