Orthotics and Achilles Load in Runners

May 13, 2020 updated by: Samuel KK Ling, North District Hospital

Controlled Trial to Compare the Achilles Tendon Load During Running in Flatfeet Subjects Using a Customized Arch Support Orthoses vs an Orthotic Heel Lift

Compare Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a controlled laboratorial, within subject, repeated measures study. The aim of this study was to compare two clinically applied treatment options: Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet. It implicated to provide a better understanding of the types of foot orthoses for flatfeet runners and additional biomechanical evidence for the clinical field to guide orthotic prescription as well as selection for Achilles tendinopathy management.

Study Type

Interventional

Enrollment (Actual)

12

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Foot Posture Index (FPI) was used as evaluating pronated foot posture. Subjects with FPI scores of 6-12 were recruited in the current study.
  • All participants should be free of Achilles tendinopathy and triceps surae injury for 6 months.
  • no previous surgery.
  • not previously attempted any foot orthoses intervention before this study.

Exclusion:

  • leg-length discrepancy
  • rigid forefoot varus deformity
  • gastrocnemius equinus
  • structural hallux limitus, or rigidus
  • Any musculoskeletal or neurological disorders

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Runner
Subject will undergo an assessment wearingeither the CASO or the HL. Sequence of CASO of HL will be randomly allocated.
Device: CASO
Customized arch support orthoses (CASO)
Device: HL
Orthotic Heel Lift (HL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak plantarflexion moment
Time Frame: Day 0
8-camera motion capturing system
Day 0
Peak Achilles tendon load
Time Frame: Day 0
Piezoelectric force platform, computed using the Newton-Euler inverse-dynamics
Day 0

Collaborators and Investigators

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

Sponsor

North District Hospital

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

Helpful Links

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)

January 1, 2019

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUHK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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