Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Ten… (NCT01749657) | Clinical Trial Compass
UnknownNot Applicable
Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Tendon Dysfunction
United States60 participantsStarted 2012-09
Plain-language summary
The lack of high quality evidence to guide conservative care for patients with posterior tibial tendon dysfunction (PTTD) has led to controversy over clinical care. Numerous orthotic devices are available to avoid a costly and debilitating surgery but no consensus on which to use has been made. The current study aims to link biomechanical testing of selected devices to clinical outcomes in subjects with PTTD after wearing a device for 12 weeks.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion Criteria Stage II PTTD
* Swelling
* Pain with Palpation along the tendon
* Rearfoot eversion
* Pain single leg heel raise
* Flexible flat foot deformity
* Able to walk 15 m
* \> 40 years of age
Exclusion Criteria:
* Unable to walk 15 m
* Symmes-Weinstein monofilament test 5.06 mm
* Inflammatory arthropathies (e.g. rheumatoid arthritis, psoriasis)
* Co-morbid foot conditions (e.g. hallux rigidis, plantar fasciitis)
* Inability to assume a STN posture
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Foot Function Index - Revised
Timeframe: 12 weeks
Trial details
NCT IDNCT01749657
SponsorState University of New York - Upstate Medical University