Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

December 2, 2014 updated by: Kornelia Kulig, University of Southern California

Phase 1 Study on Effectiveness of Exercise on Function, Quality of Life and Disability in Patients With Posterior Tibial Tendon Dysfunction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Department of Biokinesiology and Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: type of exericse
type of exercise
Procedure: Orthoses and Exercise
orthrose and exercise - daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
pre- post- 6-month post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Kornelia Kulig, PhD, PT, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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