Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 17, 2006 | ||||
| Last Updated Date | June 15, 2012 | ||||
| Start Date ICMJE | June 2002 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Foot Function Index; SF-36; walking distance in 5 minutes; time walking 50-ft; pain following the functional tests [ Time Frame: pre- post- 6-month post ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00279630 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction | ||||
| Official Title ICMJE | Phase 1 Study on Effectiveness of Exercise on Function, Quality of Life and Disability in Patients With Posterior Tibial Tendon Dysfunction | ||||
| Brief Summary | Posterior tibial tendon dysfunction (PTTD) is the most common cause of painful and debilitating acquired flatfoot deformity in adults. The dysfunction is often progressive and may result in attenuation of the PTT and eventually collapse of the plantar arch or even rupture of the tendon. Current therapeutic management of PTTD is multipronged and includes management with foot orthoses, stretching, and strengthening exercises. Evidence drawn from research related to the management of painful chronic Achilles tendinosis suggests that eccentric strengthening of the posterior tibialis may lead to superior results compared to concentric. The purpose of this research is to determine the effectiveness of treatment interventions used in the management of PTTD. |
||||
| Detailed Description | All study participants receive a pair of custom made orthoses and perform daily calf-stretches. In addition to the orthoses two groups will perform tibialis posterior specific exercises; one as concentric and the second as eccentric activation. Intervention will last 12 weeks. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE | Tendinopathy | ||||
| Intervention ICMJE | Procedure: Orthoses and Exercise
orthrose and exercise - daily |
||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Kulig K, Pomrantz AB, Burnfield JM, Reischl SF, Mais-Requejo S, Thordarson DB, Smith RW. Non-operative management of posterior tibialis tendon dysfunction: design of a randomized clinical trial [NCT00279630]. BMC Musculoskelet Disord. 2006 Jun 6;7:49. Review. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 45 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00279630 | ||||
| Other Study ID Numbers ICMJE | 022051 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Kornelia Kulig, University of Southern California | ||||
| Study Sponsor ICMJE | University of Southern California | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Southern California | ||||
| Verification Date | June 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||