The overall goal of this proposal is to establish a New York Stroke Rehabilitation Clinical Trials Network to plan and conduct randomized controlled trials of rehabilitation treatments for stroke patients. This network will be of sufficient size to conduct statistically valid trials with anticipated effect sizes that are moderate to large. The size of this network will also make it possible to contribute substantial numbers of patients to trials of more global intervention strategies or of treatments with smaller anticipated effect sizes conducted on a regional or national scale. The network will include experienced investigators at the Columbia and Cornell University medical schools, the New York Presbyterian Hospital's combined Department of Rehabilitation Medicine at the Hospital's Columbia and Cornell campuses, the Burke Rehabilitation Hospital, the Helen Hayes Rehabilitation Hospital, and the Research Division of the Hebrew Home for the Aged at Riverdale. This network will include investigators with multi-disciplinary training and experience, including the design and conduct of randomized clinical trials; rehabilitation medicine; neurology; geriatric medicine; aging research; measurement issues as they relate to multi-center studies and to outcomes in stroke, rehabilitation, and geriatric clinical research; epidemiology; and statistics. Key milestones in establishing the network will be the planning of a specific trial and submission of an R01 grant proposal.
The specific aims are (1) to plan and establish the infrastructure for the conduct of randomized trials of stroke rehabilitation treatments in a New York area network; (2) to plan a randomized trial of an intervention to prevent aspiration in stroke patients with impaired swallowing; and (3) to plan a randomized trial of multi-disciplinary care and early rehabilitation during initial hospitalization for stroke.
Aim 1 will be accomplished through a structured planning process and resource Inventory that will address issues that include data systems, data security, IRB processing, electronic collaboration, and business plan.
Aims 2 and 3 will be accomplished through pilot testing of the intervention strategy and clinical measures, collection of preliminary data, detailed sample size calculations, and writing and submission of a grant application. When this two year planning and development process for the New York Stroke Rehabilitation Clinical Trials Network is complete, we hope to contribute to a larger national effort to establish evidence derived from controlled trials to guide the cost-effective allocation of resources and improve the quality of care for stroke.
| Iizuka, Masayuki; Reding, Mike (2005) Use of percutaneous endoscopic gastrostomy feeding tubes and functional recovery in stroke rehabilitation: a case-matched controlled study. Arch Phys Med Rehabil 86:1049-52 |
| Churchill, Matthew; Grimm, Sean; Reding, Michael (2004) Risks of diuretic usage following stroke. Neurorehabil Neural Repair 18:161-5 |
