A Phase 1/2 interventional study of AMES- Leg treatment in Stroke, Cerebrovascular Accident and Hemiparesis, sponsored by AMES Technology. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-12-08.
Sponsored by AMES Technology · Phase 1/2, Interventional, and Treatment
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).
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →AMES Technology is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: AMES- Leg treatment
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.
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
Gait Assessment
The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test.
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
Measurement of spasticity in the ankle joint.
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
Measure the subject's right-left weight distribution and dynamic balance control.
Time frame: 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.
Time frame: Prior to each treatment session,
Passive Motion Test
Measures the peak resistance in the affected ankle.
Time frame: Prior to each treatment session
Active Range of Motion Test
A joint tracking task guided by visual feedback on a computer screen.
Time frame: Prior to each treatment session
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.