Institutional Review Board, Hospital for Special Surgery
August 18, 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.
Howard J. Hillstrom, PhD
Twenty children will be included in this study. Your child’s participation will involve a total of 1-2 study visits. Most visits are expected to last 2-3 hours. Pediatric physical therapists will complete a brief evaluation on your child. It will include looking at your child’s ankles and feet while lying down and when standing. A joint protractor (goniometer) and standard tape measure will be used. A digital camera will also be used to take a picture of your child’s legs while standing.Your child will walk through an obstacle course with three different types of shoes and barefoot. The obstacle course will include standing up, turning, cruising, walking across different surfaces, walking up and down a ramp. Your child will be videotaped while going through the obstacle course. Finally, your child will walk barefoot and in 3 different shoe models over a type of mat that records the child’s walking pattern on a computer. There will be special sensors placed in each of the 3 shoe models that will record the child’s weight distribution. They will also walk across a computerized plate that measures the weight distribution while barefoot.
Male and female toddlers ranging from 9 to 24 months of age that are healthy and typically developing (i.e. without a current neuromusculoskeletal pathology and developmental delay) will be recruited. Parents who are unable to understand and sign the informed consent will be excluded.
Howard Hillstrom, PhD