Clinical trial NCT00609115: Sub-Acute Stroke Rehabilitation With AMES
Official title: Sub-Acute Stroke Rehabilitation With Assisted Movement With Enhanced Sensation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Stroke
Keywords: Sub-acute care
Robotics
Lead sponsor: AMES Technology
Sponsor class: INDUSTRY
Collaborators: name: Northwest Medical Rehabilitation, Spokane, WA
name: Emory University
name: University of California, San Francisco
name: Shirley Ryan AbilityLab
name: Eisenhower Medical Center
name: Legacy Health System
First posted: 2008-02-06
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single crossover for only the control group participants from the controlled part of the study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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 hand (fingers/wrist). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Limb Portion
timeFrame: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Secondary outcomes:
measure: Stroke Impact Scale
timeFrame: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
measure: Rancho Los Amigos Functional Test
timeFrame: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
measure: Spasticity (Modified Ashworth) Scale
timeFrame: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
measure: Active Motion Test Grasp
timeFrame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
measure: Active Motion Wrist
timeFrame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
measure: Strength Grasp Flexion
timeFrame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
measure: Strength Grasp Extension
timeFrame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
measure: Strength Wrist Flexion
timeFrame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
measure: Strength Wrist Extension
timeFrame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF School of Medicine- Physical Therapy and Rehabilitation
state: California
city: Atlanta
country: United States
facility: Emory University Dept of Rehabilitation Medicine/School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Spokane
country: United States
facility: NW Medical Rehabilitation
state: Washington
Study officials:
affiliation: AMES Technology Inc./ Oregon Health and Science University
name: Paul J. Cordo, PhD
role: STUDY_DIRECTOR
References:
citation: Cordo P, Wolf S, Rymer WZ, Byl N, Stanek K, Hayes JR. Assisted Movement With Proprioceptive Stimulation Augments Recovery From Moderate-To-Severe Upper Limb Impairment During Subacute Stroke Period: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2022 Mar;36(3):239-250. doi: 10.1177/15459683211063159. Epub 2022 Jan 24.