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Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

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ClinicalTrials.gov Identifier: NCT00279630
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Kornelia Kulig, University of Southern California

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tendinopathy Procedure: Orthoses and Exercise Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2002
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: type of exericse
type of exercise
 Procedure: Orthoses and Exercise
orthrose and exercise - daily


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 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