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Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

This study is currently recruiting participants.
Verified June 2012 by University of Southern California
Sponsor:
Information provided by (Responsible Party):
Kornelia Kulig, University of Southern California
ClinicalTrials.gov Identifier:
NCT00279630
First received: January 17, 2006
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: June 2002
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279630

Contacts
Contact: Kornelia Kulig 323.442.2911 kulig@usc.edu

Locations
United States, California
Department of Biokinesiology and Physical Therapy Recruiting
Los Angeles, California, United States, 90089
Contact: Kornelia Kulig            
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Kornelia Kulig, PhD, PT University of Southern California
  More Information

No publications provided by University of Southern California

Additional 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: June 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Tibialis Posterior Tendinopathy

Additional relevant MeSH terms:
Posterior Tibial Tendon Dysfunction
Tendinopathy
Foot Diseases
Musculoskeletal Diseases
 Muscular Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013