The results of clinical trials in stroke rehabilitation research

K. J. Ottenbacher and S. Jannell
Department of Ocupational Therapy, School of Health Related Professions, State University of New York, Buffalo 14214.

RESEARCH PROBLEM AND METHODS--There are currently 1.5 million stroke survivors in the United States. More than half of these individuals have significant residual physical disability and functional impairment. Survivors of stroke constitute the largest group of patients receiving rehabilitation services in this country. We examined existing clinical trials investigating the effectiveness of stroke rehabilitation programs to improve functional outcomes and discharge destination. One hundred twenty-four research reports were initially identified. From this sample, 36 trials meeting selected criteria were evaluated by the methods of meta-analysis. RESULTS--A total of 3717 patients participated in the 36 clinical trials included in the meta-analysis. The results revealed a mean d-index of 0.40 +/- 0.33. This effect size index was converted to a U3 value of 65.5, indicating that the average patient receiving a program of focused stroke rehabilitation performed better than approximately 65.5% of those patients in comparison groups (95% confidence interval, 63.6% to 67.3%). The results also revealed a significant interaction between type of research design and method of recording the outcome of a clinical trial. Blind recording of the outcome measure appears to be an essential design characteristic in clinical trials that do not randomize patients to conditions. CONCLUSIONS--Programs of focused stroke rehabilitation may improve functional performance for some patients who have experienced a stroke. The improvement in performance appears related to early initiation of treatment, but not to the duration of intervention. Improvements are also associated with the patient's age and the type of design. Research design should be considered an important moderator variable in planning and interpreting future clinical trials of treatment effectiveness in stroke rehabilitation.

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