Clinical Assessment of a Massed Practice Therapy Device

DESCRIPTION (provided by applicant): This proposal addresses the need expressed in Program Announcement PA-02-071 to utilize innovative technologies to improve the physical and mental function of individuals with disabilities. Many stroke survivors have significant limitations of upper extremity function which have an impact on many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. However, costs often limit the number of patients that receive this type of therapy. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Phase I of this program demonstrated through laboratory testing and pilot clinical trials the feasibility of this innovative air muscle driven interactive device to provide effective and cost effective therapy. The primary aim of the proposed study is to determine in a randomized, controlled, single blind parallel clinical trial whether the use of this innovative biofeedback technology of Active Repetitive Motion (ARM) therapy in a home environment will increase function and improve the cognitive, emotional, and physical health of people with stroke and in this potentially cost effective manner. One hundred sub-acute (3 to 9 mos post stroke) patients will be randomized to a group that is trained on ARM device therapy and utilize it at home for 3 months or to a group with no ARM therapy. Both groups will receive usual and customary care. Clinical motor function and quality of life measures will compare the groups before intervention, immediatley after, and 3 months later. A subset will be evaluated 1 year later. We hypothesize that the ARM therapy group will improve more than the other group. Time spent using the device and the amount of usual and customary care received by each patient will be recorded, statistically analyzed and comparisons made. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project also has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.