Institutional Review Board, Hospital for Special Surgery
November 05, 2008
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.
Jocelyn Hafer, MA
Twenty healthy runners and twenty runners diagnosed with iliotibial band syndrome (ITBS) will be included in this study. This investigation requires only one visit which is expected to last 90 minutes. Runners will first complete a training questionnaire. Next, a physical therapist will measure hip muscle strength as well as flexibility and alignment of the legs and feet. Runners will then be asked to walk and run through the laboratory while electrodes on their muscles measure muscle activity and cameras collect information regarding how their legs are moving. Runners will then perform a run on a treadmill until they reach fatigue. They will then repeat the walk/run procedure through the laboratory and strength/flexibility measurements will be repeated. This will complete the visit.
Inclusion criteria for both the runners with ITBS and the uninjured runners are:
i. Female, ages 18 to 50 years, diagnosed with ITBS, or a normal healthy runner
ii. Free of any other musculoskeletal or neuromuscular disorders
iii. Running = 15 miles per week for at least one year
iv. Rearfoot striker
v. Able to run a 9 minute mile
vi. Able to read and understand English
vii. Diagnosis of ITBS must be made by a medical professional and must be consistently present within the span of a 1-hour run
Exclusion Criteria: Potential subjects will not be included for participation if they do not fit the inclusion criteria.
Jocelyn Hafer, MA