A total of 93 patients with intractable spasticity due to either spinal cord injury (59 cases), multiple sclerosis (31 cases), or other spinal pathology (three cases) were entered into a randomized double-blind placebo-controlled screening protocol of intrathecal baclofen test injections. Of the 88 patients who responded to an intrathecal bolus of 50, 75, or 100 micrograms of baclofen, 75 underwent implantation of a programmable pump system for chronic therapy. Patients were followed for 5 to 41 months after surgery (mean 19 months). No deaths or new permanent neurological deficits occurred as a result of surgery or chronic intrathecal baclofen administration. Rigidity was reduced from a mean preoperative Ashworth scale score of 3.9 to a mean postoperative score of 1.7. Muscle spasms were reduced from a mean preoperative score of 3.1 (on a four-point scale) to a mean postoperative score of 1.0. Although the dose of intrathecal baclofen required to control spasticity increased with time, drug tolerance was not a limiting factor in this study. Only one patient withdrew from the study because of a late surgical complication (pump pocket infection). Another patient received an intrathecal baclofen overdose because of a human error in programming the pump. The results of this study indicate that intrathecal baclofen infusion can be safe and effective for the long-term treatment of intractable spasticity in patients with spinal cord injury or multiple sclerosis.

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The structural design, control system, and integrated biofeedback for a wearable exoskeletal robot for upper extremity stroke rehabilitation are presented. Assisted with clinical evaluation, designers, engineers, and scientists have built a device for robotic assisted upper extremity repetitive therapy (RUPERT). Intense, repetitive physical rehabilitation has been shown to be beneficial overcoming upper extremity deficits, but the therapy is labor intensive and expensive and difficult to evaluate quantitatively and objectively. The RUPERT is developed to provide a low cost, safe and easy-to-use, robotic-device to assist the patient and therapist to achieve more systematic therapy at home or in the clinic. The RUPERT has four actuated degrees-of-freedom driven by compliant and safe pneumatic muscles (PMs) on the shoulder, elbow, and wrist. They are programmed to actuate the device to extend the arm and move the arm in 3-D space. It is very important to note that gravity is not compensated and the daily tasks are practiced in a natural setting. Because the device is wearable and lightweight to increase portability, it can be worn standing or sitting providing therapy tasks that better mimic activities of daily living. The sensors feed back position and force information for quantitative evaluation of task performance. The device can also provide real-time, objective assessment of functional improvement. We have tested the device on stroke survivors performing two critical activities of daily living (ADL): reaching out and self feeding. The future improvement of the device involves increased degrees-of-freedom and interactive control to adapt to a user's physical conditions.

Design: This paper describes a treatment paradigm to facilitate functional gait in a quadriplegic, ASIA C spinal cord injured (SCI), wheelchair-dependent subject who presented with some large ®ber sensation, sub-functional motor strength in all lower limb muscles, and moderate spasticity. The study utilizes partial weight bearing therapy (PWBT) followed by epidural spinal cord stimulation (ESCS) with the assumption that both treatments would be necessary to elicit a well organized, near eortless functional gait with a walker. Function is de®ned in terms of accomplishing task-speci®c activities in the home and community. Objectives: To demonstrate the feasibility and bene®ts of combined PWBT and ESCS therapies aimed at promoting functional gait in a wheelchair-dependent ASIA C SCI subject. Setting: The Clinical Neurobiology and Bioengineering Research Laboratories at Good Samaritan Regional Medical Center, Phoenix, Arizona, USA, and the Department of Bioengineering, Arizona State University, Tempe, Arizona, USA. Methods: The study began with the application of PWBT. The subject walked on the treadmill until a plateau in gait rhythm generation was reached. Subsequently, ESCS, applied to the lumbar enlargement, was utilized to facilitate PWBT and, later, over-ground walking for a standard distance of 15 m. Gait performance was analyzed by measuring average speed, stepping symmetry, sense of eort, physical work capacity, and whole body metabolic activity. Results: PWBT led to improved stereotypic stepping patterns associated with markedly reduced spasticity, but was insucient for over-ground walking in terms of safety, energy cost, and fatigue. ESCS with PWBT generated immediate improvement in the subject's gait rhythm when appropriate stimulation parameters were used. When compared to the non-stimulated condition, over-ground walking with ESCS across a 15 m distance was featured by a reduction in time and energy cost of walking, sense of eort, and a feeling of`lightness' in the legs. After a few months of training, performance in speed, endurance, and metabolic responses gradually converged with/without ESCS at this short distance, suggesting a learned response to these conditions. However, at longer distances (eg, 50 ± 250 m), performance with ESCS was considerably superior. The subject was able to perform multiple functional tasks within the home and community with ESCS. Conclusion: We propose that ESCS augments the use-dependent plasticity created by PWBT and may be a valuable adjunct to post-SCI treadmill training in ASIA C subjects. We also conclude that ESCS elicits greater activation of an oxidative motor unit pool, thereby reducing the subject's sense of eort and energetic cost of walking.