BACKGROUND: Approximately 800,000 Americans will have a stroke this year, and half will have a chronic hemiparesis. Substantial animal literature has demonstrated tremendous recovery from acute injury using mechanisms of neuroplasticity. However, most of these findings have not been tested or confirmed in rehabilitation settings. There is rodent evidence for timing effects in rehabilitation; motor training delivered at certain times may be more effective. If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery.

The Critical Periods After Stroke Study (CPASS) is a Phase II randomized controlled trial (RCT) designed to explore whether such a sensitive period exists. In this study, we are randomizing 64 persons to receive an additional bolus of 20 hr of upper-extremity (UE) therapy immediately upon rehab admission, at 2–3 mo after stroke onset, or at 6 mo after onset or to an observation-only control group.

PURPOSE: The purpose of this presentation is to present the development of the client-centered motor training protocol designed for the CPASS trial. This treatment protocol guided by principles of motor learning and intrinsic motivation was created by a multidisciplinary team to meet the standards of rigor and reproducibility needed for a multicenter RCT while preserving the freedom and flexibility needed to maintain an occupation-based client centered approach to UE therapy.

METHOD: Sixty-five functional activities requiring UE performance assessed by the Activity Card Sort (ACS) are presented during the treatment planning phase to identify prestroke social, instrumental, and high- and low-demand leisure UE activities. Participants are asked to identify and rank 10 of the most important activities that they want to focus on during their treatment; they are also able to add activities not included in the ACS. The shaping treatment developed for use in VECTORS, the National Institute of Neurological Disorders and Stroke–funded Phase II trial was modified and used to structure 20 hr of therapy in addition to occupational therapy provided as part of standard clinical care.

The selection of tasks is very important because the participant must be committed to achieving the goal despite the difficulty of task performance. Therapists grade the tasks to provide enough challenge to encourage progress while guarding against frustration and failure, which act as negative reinforcers and decrease the probability of full participation in the treatment program. The therapist offers positive reinforcement in the forms of verbal and video feedback. Task difficulty is increased when the participant completes two sets of 10 correct repetitions of task performance on 2 consecutive days of treatment. All participants receive 20 hr of therapy in addition to their usual and customary care.

RESULTS: Sixteen of the proposed 65 patients have been enrolled to date. Treatment activities for patients enrolled at each treatment interval will be presented to illustrate the development and implementation of individualized treatment protocols for each of the three treatment groups. Task analysis, activity grading, and documentation will be presented for each plan.

DISCUSSION: It is a challenge to develop and implement a rigorous and reproducible treatment protocol based on principles of client-centered care. We believe that use of meaningful activities and individualized treatment plans support translation of animal studies of neuroplasticity after stroke into human treatment trials. We hope to demonstrate that occupation-based shaping paradigms will yield better treatment outcomes than simple repetition of graded motor tasks.