Stroke is the leading cause of disability among adults in the United States. Each year in the U.S., approximately 550,000 people suffer strokes and nearly 400,000 survive with some level of disability. The cumulative total of living, stroke-affected Americans is nearly 3 million. Thirty billion dollars annually is the estimated burden from stroke-related disability. Despite the enormity of these statistics, there have been few scientific studies of the effectiveness of post-stroke rehabilitation interventions. As a result, the recently published Clinical practice guidelines for post-stroke rehabilitation have been forced to rely primarily on expert opinion and not on well controlled scientific studies. This project is a first step toward remedying this; it will provide pilot data for a large scale randomized clinical trial of rehabilitation interventions during the subacute phase. The goal of this small grants proposal is to obtain preliminary data to: 1) Assess the feasibility of conducting a large scale, randomized, clinical trial (RCT) evaluating the effectiveness of three physical rehabilitative interventions (""""""""usual care"""""""", """"""""strengthening"""""""" and """"""""functional use"""""""") on restoration of arm use after unilateral stroke, 2) Fine tune the experimental design and intervention procedures for a large scale RCT to evaluate the effectiveness of these three interventions and 3) Obtain preliminary data on short-term and long-term effectiveness. Specifically, the proposal is designed to: 1) Assess recruitment, retention, and compliance; develop the operational components including a manual of procedures and standardized data collection forms; and build a database system and a communications system, 2) Examine eligibility/ineligibility criteria; assess the benefits/detriments of a two vs. three arm RCT design; and assess intervention time, outcome measures, and sensitivity of assessment instruments and 3) Determine requisite sample size power calculations; obtain preliminary data pertaining to the prognostic implications of initial impairments (neurological and neuromuscular) with regard to each of the interventions; and obtain preliminary data regarding whether the recovery and response is influenced by lesion characteristics.
| Winstein, Carolee J; Rose, Dorian K; Tan, Sylvia M et al. (2004) A randomized controlled comparison of upper-extremity rehabilitation strategies in acute stroke: A pilot study of immediate and long-term outcomes. Arch Phys Med Rehabil 85:620-8 |
