The Current State of Technology Transfer in Rehabilitation

This definition of technology transfer has application for rehabilitation science: the biomedical and engineering applications of rehabilitation research can follow some, but not all, of the traditional technology transfer mechanisms. Rehabilitation research does pose a new challenge that requires additional mechanisms for transfer, because much of the research results in therapeutic interventions that are applied in exercise techniques and educational strategies by professionals, not through the use of drugs or equipment.

In traditional pharmaceutical clinical research, after a drug is synthesized in the laboratory and tested with animal models or after the device is developed and bench tested, it is subjected to clinical (phase I to IV) trials—research studies designed to address specific questions about the safety and effectiveness of new methods or tools in prevention or treatment—supervised by the U.S. Food and Drug Administration (FDA). Phase I trials focus on safety and usually involve small samples (20 to 100) of healthy volunteers. Phase II trials test the efficacy of the drug, usually in studies with dozens or hundreds of patients and often in randomized controlled trials. Phase III trials test the safety, efficacy, and possible adverse reactions, usually in multicenter, randomized, and blinded trials. Phase IV studies usually compare the new therapy with the available alternative interventions and determine its long-term effectiveness and side effects and the cost-effectiveness of the intervention(s) (Pocock, 1987). Most clinical research is funded by private industry (biotechnology or pharmaceutical companies) or the federal government (e.g., the National Institutes of Health [NIH], the National Science Foundation, the Centers for Disease Control and Prevention, or the National Institute on Disability and Rehabilitation Research [NIDRR]).

The successful transfer of rehabilitation interventions such as therapeutic exercise and physical modalities from research to practice poses a different set of problems than the transfer of drugs. Drugs are discrete entities and are thus easily regulated by the federal government, but rehabilitation interventions are more generic and are less amenable to FDA regulation. Indeed, most such interventions would be "grandfathered" because despite subtle differences in approach, practice regimen, and other details, most rehabilitation interventions would still be "exercise" and thus not subject to regulation. Nonetheless, initiatives such as the stroke care guidelines of the Agency for Health Care Policy and Research provide valuable federal guidance to local practitioners (Gresham et al., 1995) by offering structure to the best and evidence-based practices that should result in comparable care for individuals following a stroke. Reha-

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