Institutional Review Board, Hospital for Special Surgery
March 17, 2010
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Howard J. Hillstrom, MD, PhD
Sherry I. Backus, PT, DPT, MA
Andrew Kraszewski, MS
Mark Lenhoff, BS
Allison Brown, PhD, PT
100 runners, 50 male and 50 female, will be enrolled in this registry. Subjects will take part in a comprehensive analysis of their running mechanics, strength, structure, muscle function, and foot pressure patterns. All data will be collected during 1 visit that will last approximately 3-4 hours. This study will not require any additional time commitment from normal, uninjured participants recruited from other running-related studies.
All subjects must be:
• Between the ages of 18 and 65 years old
• Running at least 15 miles per week
Subjects will be excluded from participation in this study if they have any of the following characteristics:
• Have a history of systemic, metabolic, neurological, or musculoskeletal disease that would affect lower extremity function
• Have a history of running-related injury in the last six months
• Wear orthotic devices of any type while running
Jocelyn Hafer, MA