StrokePhase 1/2AMESNCT01378637
AMES Treatment of the Impaired Leg in Chronic Stroke Patients
A Phase 1/2 study testing AMES- Leg treatment in people with Stroke and Cerebrovascular Accident, run by AMES Technology at 2 sites in United States.
Trial summary
The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy device (AMES). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Cerebrovascular Accident, Hemiparesis
- What is being tested?
- AMES- Leg treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Jul 2017
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spastic hemiparesis
- At least 12 months post-stroke
- Can comfortably fit foot in treatment device
- Functioning proprioception
- Fugl-Meyer LE score >6 and <23
- Minimal hemi-neglect
- Observable volitional movement of the ankle in either plantar- or dorsi-flexion
- Cognitively and behaviorally capable of complying with the regimen
Who cannot join
- Fractures of treated limb resulting in loss of range of motion
- Spinal cord injury
- Deep venous thrombosis
- Peripheral nerve injury or neuropathy in the affected limb with motor disability
- Osteoarthritis limiting range of motion
- Uncontrolled high blood pressure/angina
Show all 12Show fewer
- Exercise intolerant
- Skin condition not tolerant of device
- Progressive neurodegenerative disorder
- Uncontrolled seizure disorder
- Botox treatment within last 5 months
- Baclofen pump
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University/Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
Oregon Health and Science University
Portland, Oregon, 97006
About this study
The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy device (AMES).
Read the detailed description
Our research objective is to develop procedures to rehabilitate those stroke patients who, through conventional therapies, are not brought to a level of maximal recovery. The aims of the proposed project are to obtain a set of data from a total of 20 chronic stroke subjects, all with severe lower extremity disability, between the ages of 18-85, using a robotic therapeutic device placed in a rehabilitation clinic. This data will allow us to quantify the extent to which a combination of robotic-assisted exercise and tendon vibration from the AMES beta device induces secondary recovery from the effects of stroke on the lower extremity.
- Conditions
- Stroke, Cerebrovascular Accident, Hemiparesis
- Being tested
- AMES- Leg treatment
- Keywords
- Leg, Robotic device, AMES, Stroke, Cerebrovascular Accident, Rehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMES- Leg treatmentDevice
30 minutes of treatment of the leg consisting of the AMES device passively moving the ankle between plantarflexion and dorsiflexion with vibration of the tendons being stretched, while the participant tries to assist in the movement as much as possible.
| Study group | Role | What they receive |
|---|---|---|
| AMES Leg treatment | Experimental | An investigational device flexes and extends the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the foot. The subject's task is to assist the motion of the device by pulling or pushing with the foot. Feedback of ankle torque or the electrical signal produced by the muscles (EMG) while the subject is assisting the motion is provided during the 30 treatment sessions. Receives: Device: AMES- Leg treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Motor Assessment of the Lower Affected Extremity
Measured: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Secondary outcomes (6)
Gait Assessment
The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test.
Measured: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Modified Ashworth Scale
Measurement of spasticity in the ankle joint.
Measured: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Dynamic Balance/Weight Distribution
Measure the subject's right-left weight distribution and dynamic balance control.
Measured: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Ankle Strength
Measurement of three attempts of dorsiflexion and three attempts of plantarflexion.
Measured: Prior to each treatment session,
Passive Motion Test
Measures the peak resistance in the affected ankle.
Measured: Prior to each treatment session
Active Range of Motion Test
A joint tracking task guided by visual feedback on a computer screen.
Measured: Prior to each treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2016
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AMES Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University, Northwestern University, Shirley Ryan AbilityLab, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Barry Oken, MD, Principal investigator, Oregon Health and Science UniversityElliot Roth, MD, Principal investigator, Northwestern University/Rehabilitation Institute of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378637
- Sponsor's protocol ID
- 7034
- Other IDs
- R44NS060192-03
- Acronym
- AMES
- Status last verified
- Dec 2016
- First submitted
- 18 Feb 2011
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMES Treatment of the Impaired Leg in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT01378637
- Acronym / sponsor ID
- AMES / 7034
- Conditions
- Stroke, Cerebrovascular Accident, Hemiparesis
- Keywords
- Leg, Robotic device, AMES, Stroke, Cerebrovascular Accident, Rehabilitation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AMES TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University, Northwestern University, Shirley Ryan AbilityLab, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 22 Jun 2011 (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.
The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy device (AMES).
Detailed description
Our research objective is to develop procedures to rehabilitate those stroke patients who, through conventional therapies, are not brought to a level of maximal recovery. The aims of the proposed project are to obtain a set of data from a total of 20 chronic stroke subjects, all with severe lower extremity disability, between the ages of 18-85, using a robotic therapeutic device placed in a rehabilitation clinic. This data will allow us to quantify the extent to which a combination of robotic-assisted exercise and tendon vibration from the AMES beta device induces secondary recovery from the effects of stroke on the lower extremity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMES Leg treatment | Experimental | Device: AMES- Leg treatmentAn investigational device flexes and extends the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the foot. The subject's task is to assist the motion of the device by pulling or pushing with the foot. Feedback of ankle torque or the electrical signal produced by the muscles (EMG) while the subject is assisting the motion is provided during the 30 treatment sessions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Spastic hemiparesis
- At least 12 months post-stroke
- Can comfortably fit foot in treatment device
- Functioning proprioception
- Fugl-Meyer LE score >6 and <23
Key exclusion criteria (12 listed)
- Fractures of treated limb resulting in loss of range of motion
- Spinal cord injury
- Deep venous thrombosis
- Peripheral nerve injury or neuropathy in the affected limb 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 |
|---|---|---|
| AMES- Leg treatment30 minutes of treatment of the leg consisting of the AMES device passively moving the ankle between plantarflexion and dorsiflexion with vibration of the tendons being stretched, while the participant tries to assist in the movement as much as possible. | Device | AMES Leg treatment |
Primary outcome
Fugl-Meyer Motor Assessment of the Lower Affected Extremity
Time frame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
6 secondary outcomes
Gait Assessment
Time frame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Modified Ashworth Scale
Time frame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Dynamic Balance/Weight Distribution
Time frame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Ankle Strength
Time frame: Prior to each treatment session,
Passive Motion Test
Time frame: Prior to each treatment session
Active Range of Motion Test
Time frame: Prior to each treatment session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute 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
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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
Elliot Roth, MD principal investigator
Northwestern University/Rehabilitation Institute of Chicago
2 sites 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 AMES- Leg treatment in people with Stroke and Cerebrovascular Accident, run by AMES Technology at 2 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 12 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: status not confirmed, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Results are not available in the source record.
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 Motor Assessment of the Lower Affected Extremity (time frame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2016.