Biomechanical Effects of Three Types of Foot Orthoses in Individuals With Posterior Tibialis Tendon Dysfunction

April 30, 2024 updated by: Philippe Corbeil, Laval University

Background :

Posterior tibialis tendon dysfunction (PTTD) is characterized by a loss of function of the muscle caused by the degeneration of the tendon leading to a flattening of the arch. FOs can be used as a treatment option, but their biomechanical effects are not yet fully understood. The aim of this study was to investigate the effects of three different types of foot orthoses (FOs) on gait biomechanics in individuals suffering from PTTD.

Methods :

Fourteen individuals were recruited with painful stage 1 or 2 PTTD based on the Johnson and Strom's classification. Quantitative gait analysis of the affected limb was performed in four conditions: shoed condition (Shoe), prefabricated FOs condition (PFO), neutral custom FOs condition (CFO) and five degrees varus (medial wedge) with a 4 mm medial heel skive custom FOs condition (CVFO). A curve analysis, using 1D statistical parametric mapping (SMP), was used to assess differences in lower limb joint motion, joint moments and muscle activity over the stance phase of gait across conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

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

  • Canada
      • Quebec, Canada, G1V 0A6
        • Pavillon de l'Éducation Physique et des Sports - Université Laval

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptoms located to the medial ankle or foot Pain on palpation to the posterior tibialis muscle tendon Positive single or double heel-rise test Foot flattening and ''too many toes" sign

Exclusion Criteria:

  • Rigidity of those deformities Pain on palpation of the peroneal muscles Wearing any type of foot and/or ankle orthoses one month prior to the study onset History of corticosteroid injection in the tendon one month prior to the study onset Having a neurological disease or past history of surgery to the affected ankle

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No orthoses
Walk at a self-selected pace without orthoses.
Active Comparator: Prefabricated foot orthoses (PFO)
Walk at a self-selected pace with prefabricated foot orthoses (PFO).
Device: Foot Orthoses
Three types of foot orthoses (FO), Prefabricated FO, Custom FO, Custom with a 5° varus FO
Other Names:
  • Foot Orthosis
Active Comparator: Custom-fitted orthoses (CFO)
Walk at a self-selected pace with custom-fitted orthoses (CFO)
Device: Foot Orthoses
Three types of foot orthoses (FO), Prefabricated FO, Custom FO, Custom with a 5° varus FO
Other Names:
  • Foot Orthosis
Active Comparator: Custom-fitted orthoses with a 5deg varus (CFVO)
Walk at a self-selected pace with custom-fitted orthoses with a 5deg varus (CFVO)
Device: Foot Orthoses
Three types of foot orthoses (FO), Prefabricated FO, Custom FO, Custom with a 5° varus FO
Other Names:
  • Foot Orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower limbs' joint motion, joint moments and muscle activity
Time Frame: During the lab session
A comparison of the lower limbs' joint motion, joint moments and muscle activity over the stance phase of gait between conditions
During the lab session
Comfort of the orthoses
Time Frame: During the lab session
A comparison of the mean perceived comfort in each experimental condition.
During the lab session

Collaborators and Investigators

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

Sponsor

Laval University

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 (Actual)

June 1, 2018

Primary Completion (Actual)

August 28, 2018

Study Completion (Actual)

September 12, 2019

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-20-2018-4003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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