Clinical trial NCT00847704: Clinic-Based AMES Treatment of Stroke
Official title: Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Stroke
Cerebrovascular Accident
Keywords: Stroke
Rehabilitation
Robotics
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: AMES Technology
First posted: 2009-02-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Progressive neurodegenerative disorder
* Uncontrolled seizure disorder
* Botox treatment within the last 5 months
* Baclofen pump

Primary outcomes:
measure: Fugl-Meyer Assessment of the Lower Extremity
timeFrame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Secondary outcomes:
measure: Timed 10-Meter Walk
timeFrame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
measure: Stroke Impact Scale
timeFrame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
measure: Spasticity (Modified Ashworth) Scale
timeFrame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
measure: Strength Test
timeFrame: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
measure: Active Motion Test
timeFrame: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: AMES Technology Inc./Oregon Health and Science University
name: Paul J. Cordo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.