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Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

Primary Purpose

Tendinopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Orthoses and Exercise
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Tibialis Posterior Tendinopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Biokinesiology and Physical Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

type of exericse

Arm Description

type of exercise

Outcomes

Primary Outcome Measures

Foot Function Index; SF-36; walking distance in 5 minutes; time walking 50-ft; pain following the functional tests

Secondary Outcome Measures

Full Information

First Posted
January 17, 2006
Last Updated
December 2, 2014
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00279630
Brief Title
Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction
Official Title
Phase 1 Study on Effectiveness of Exercise on Function, Quality of Life and Disability in Patients With Posterior Tibial Tendon Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
Tibialis Posterior Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
type of exericse
Arm Type
Experimental
Arm Description
type of exercise
Intervention Type
Procedure
Intervention Name(s)
Orthoses and Exercise
Intervention Description
orthrose and exercise - daily
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kornelia Kulig, PhD, PT
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biokinesiology and Physical Therapy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16756656
Citation
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. doi: 10.1186/1471-2474-7-49.
Results Reference
derived

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Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

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