Abstract
Background. Conventional methods of rehabilitation in patients with chronic, severe motor impairments after stroke usually do not lessen paresis. Objective. A novel therapeutic approach (assisted movement with enhanced sensation [AMES]) was employed in a medical device phase I clinical trial to reduce paresis and spasticity and, thereby, to improve motor function. Methods. Twenty subjects more than 1 year poststroke with severe motor disability of the upper or lower extremity were studied. A robotic device cycled the ankle or the wrist and fingers at 5°/s through ±17.5° in flexion and extension while the subject assisted this motion. Feedback of the subject's active torque was displayed on a monitor. Simultaneously, 2 vibrators applied a 60 pps stimulus to the tendons of the lengthening muscles, alternating from flexors to extensors as the joint rotation reversed from extension to flexion, respectively. Subjects treated themselves at home for 30 min/day for 6 months. Every other day prior to treatment, the therapy device performed automated tests of strength and joint positioning. Functional testing was performed prior to enrollment, immediately after completing the protocol, and 6 months later. Functional tests included gait and weight distribution (lower extremity subjects only) and the Stroke Impact Scale. Results. Most subjects improved on most tests, and gains were sustained for 6 months in most subjects. No safety problems arose. Conclusion. The AMES strategy appears safe and possibly effective in patients with severe chronic impairments. The mechanism underlying these gains is likely to be multifactorial.