Overview

This trial is active, not recruiting.

Condition cerebrovascular stroke
Treatments ames device, ames device (sham)
Phase phase 2/phase 3
Sponsor AMES Technology
Collaborator NW Medical Rehabilitation
Start date September 2007
End date June 2014
Trial size 132 participants
Trial identifier NCT00609115, CT001

Summary

The AMES device is designed to produce functional cortical changes by:(1) assisting the subject as he/she attempts to move the limb (assisted movement) and (2) enhancing movement sensation by vibrating the muscles during movement (enhanced sensation). The primary hypothesis is that the combination of assisted movement and enhanced sensation from muscle vibration can increase the amount of motor recovery in individuals disabled by a stroke.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
The Test Group will have 18 half hour AMES (Assisted Movement with Enhanced Sensation) treatments per qualified subject limb with the AMES device. Sessions to be scheduled preferably 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
ames device
Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
(Sham Comparator)
Eighteen treatment sessions for each qualifying subject limb using the AMES device programed to provide placebo therapy. Each treatment session consisting of 30 minutes of placebo therapy. Sessions to be scheduled preferably 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
ames device (sham)
Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session to provide thirty minutes of the placebo form of AMES therapy.
(Active Comparator)
Crossover treatment of subjects who received placebo treatment during Phase 1 of the study to provide 18 regular (i.e., non-placebo) AMES (Assisted Movement with Enhanced Sensation) treatment sessions. Sessions to be scheduled preferably 2 to 3 times per week with each session one-half hour in length.
ames device
Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed as soon as possible after the completion of Arm C-1 Sham Comparator.

Primary Outcomes

Measure
Fugl-Meyer Assessment
time frame: Pre-treament, post-treatment, post crossover treatment

Secondary Outcomes

Measure
Stroke Impact Scale
time frame: Pre-treatment, post-treatment, post crossover treatment
Gait test
time frame: Pre-treatment, post-treatment, post crossover treatment
Rancho Los Amigos Functional Test
time frame: Pre-treatment, post-treatment, post-crossover treatment
Spasticity (Modified Ashworth) Scale
time frame: Pre-treatment, post-treatment, post crossover treatment
Passive Motion Test
time frame: Prior to each treatment session
Joint Position Test
time frame: Prior to each treatment session
Strength Test
time frame: Prior to each treatment session

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Hemispheric stroke (ischemic or hemorrhagic), cortical or sub-cortical, documented by either a CT or MRI scan and associated with residual weakness in the arm and/or leg. - First time ever stroke or previous stroke with complete resolution of motor deficit, occurring ≤4 months prior to subject enrollment. - Age 18-80 years old. - Moderate to severe lower-extremity paresis (defined as a leg motor Fugl-Meyer score of ≥6 and ≤22 out of a possible 34. - Moderate to severe upper-extremity paresis (defined as an arm motor Fugl-Meyer score of ≥6 and ≤43 out of a possible 66. - Visible voluntary movement of the ankle in at least one direction: dorsiflexion or plantarflexion for the ankle and flexion or extension for the hand. - At least partially functioning proprioception from the paretic arm or leg—capable of correctly identifying, ≥70% of the time, the direction of passive joint rotation (i.e., flexion-extension) with eyes closed. - Physically and cognitively capable of consenting to and complying with the protocol. - Score of <19 out of 63 on the 21-question version of the Beck Depression Inventory. - Subject or legally authorized representative must be capable of providing informed consent.- Exclusion Criteria: - Complete flaccidity of the hand, wrist, and ankle. - Pathological neurological/physical conditions, other than stroke, impairing the function of the impaired arm or leg or resulting in pain in either the arm or leg. - Spinal cord injury, arthritis, or fractures of affected limbs that have resulted in loss of range of motion. - Peripheral nerve injury or neuropathy resulting in significant motor or sensory loss in the limb being considered for testing. - 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. - Major active psychiatric disorder. - Severe apraxia; inability to understand verbal (English) directions; or inability to communicate adequately with study personnel. - Size of arm or leg incompatible with the AMES device. - Severe contractures or decreased range of motion that would prohibit comfortable positioning or tolerance of the device - Skin condition not able to tolerate use of the AMES device. - Any progressive neurodegenerative disorder affecting the 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 or clinical trial. - NIH Stroke Scale, following scores: Item 1a > 0; Item 1c > 0; Item 2 > 0; Item 3 > 0; Item 9 > 2; Item 10 > 1; Item 11 > 1 (based on exam by Study Physician). - Intent to receive Botox injections, initiation of antispasmodic medication, or use any other robotic (e.g., MANUS, Locomat) or stimulation device (e.g., Bioness) while participating in the AMES trial.

Additional Information

Official title Sub-Acute Stroke Rehabilitation With Assisted Movement With Enhanced Sensation
Description Approximately 700,000 U.S. citizens have a stroke each year with about half ending up with significant motor disabilities. There are an estimated 5 million stroke survivors in the U.S., making strokes the leading cause of long-term disability in the U.S.. Existing rehabilitation therapies have not been effective in returning all stroke survivors to full motor recovery. The AMES device was designed to be able to provide therapy for the ankle joint and the hand (fingers/wrist). Subjects may qualify for one or two limbs. In this 18 treatment sessions, double-blinded, control study, AMES therapy will be provided in addition to the usual physician-ordered rehabilitation during the sub-acute period following a stroke. Those control subject who complete the Phase 1 placebo sessions will have the opportunity to cross-over to participate in a AMES treatment group for a Phase 2.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by AMES Technology.