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Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction
This study has been completed.
Sponsor:
University of Southern California
Information provided by (Responsible Party):
Kornelia Kulig, University of Southern California
ClinicalTrials.gov Identifier:
NCT00279630
First received: January 17, 2006
Last updated: December 2, 2014
Last verified: December 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Tendinopathy | Procedure: Orthoses and Exercise | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 1 Study on Effectiveness of Exercise on Function, Quality of Life and Disability in Patients With Posterior Tibial Tendon Dysfunction |
Resource links provided by NLM:
Further study details as provided by Kornelia Kulig, University of Southern California:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 45 |
| Study Start Date: | June 2002 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: type of exericse
type of exercise
|
Procedure: Orthoses and Exercise
orthrose and exercise - daily
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pain (> 3 months duration)
- Pain localized to the medial ankle and foot
- Swelling at the medial ankle
- Able to perform a single controlled heel lowering
Exclusion Criteria:
- Bilateral posterior tibial tendon dysfunction
- Fixed foot deformities
- Previous foot surgery
- Presence of any other concurrent foot pathology besides posterior tibial tendon dysfunction
- Ability to walk only with assistive device
- Neurological disorders
- Cognitive dysfunction
- Uncontrolled cardiovascular disease
- Evidence of cord compression
- Uncontrolled hypertension
- Infection
- Severe respiratory disease
- Pregnancy
- Current or recent history of low back pain
- Known rheumatic joint disease
- Peripheral vascular disease with sensory loss of the foot.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00279630
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279630
Locations
| United States, California | |
| Department of Biokinesiology and Physical Therapy | |
| Los Angeles, California, United States, 90089 | |
Sponsors and Collaborators
University of Southern California
Investigators
| Principal Investigator: | Kornelia Kulig, PhD, PT | University of Southern California |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kornelia Kulig, Professor, University of Southern California |
| ClinicalTrials.gov Identifier: | NCT00279630 History of Changes |
| Other Study ID Numbers: |
022051 |
| Study First Received: | January 17, 2006 |
| Last Updated: | December 2, 2014 |
Keywords provided by Kornelia Kulig, University of Southern California:
|
Tibialis Posterior Tendinopathy |
Additional relevant MeSH terms:
|
Tendinopathy Posterior Tibial Tendon Dysfunction Muscular Diseases Musculoskeletal Diseases |
Tendon Injuries Wounds and Injuries Foot Diseases |
ClinicalTrials.gov processed this record on June 22, 2017