Orthotics and Running

October 20, 2022 updated by: Talita Cumi Ltd.

A Randomised Control Trial to Compare Comfort, Rate of Injury and Speed While Running Using Prefabricated Orthotic Inserted Into Running Shoes vs Running With no Additional Orthotic Inside the Running Shoe

To investigate whether a prefabricated Orthotic inserted into running shoes will increase comfort, decrease injury and improve speed during recreational running as compared to running shoes without the prefabricated Orthotic.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Running is the most accessible sport in the world. Data from the UK House of Commons has indicated that running has become the favourite exercise among adults 16 or older. However, as the sport grows, so too does the number of running-related injuries (RRIs).

An Orthotic is a device that is placed inside the shoe and functions as a cushion to absorb the shock transmitted on contact with the ground; in addition, they also affect muscle activation that can benefit the user. However, in contemporaneous medical literature, there are mixed views and opinions on whether the use of Orthotics reduces running-related injuries.

This is a randomised control trial that will be conducted over an 8-week period, during which participants will be asked to complete runs and provide data in the form of completed surveys. The primary objective of this study is to investigate whether a prefabricated Orthotic inserted into running shoes will increase comfort, decrease injury and improve speed during recreational running as compared to running shoes without the prefabricated Orthotic.

The study population will include 106 participants who will be randomised into the study and control group. Participants in the study group will be provided with an Orthotic and will run with this in the participants normal running shoes. Participants in the control group will not be provided with the Orthotic and will run in the participants regular running shoes.

All participants (in both groups) will be asked to provide data following each run and also once a week regarding any injury sustained in the preceding 7 days. The minimum required data set will comprise of the personal details and consent on initial enrolment, ongoing consent and data from at least 10 runs (there are 5 individual pieces of information from each run - the date of the run, the distance, the time taken, whether an Orthotic was used or not and the comfort during the run), and injury data every week during the 8 week study period.

Study Type

Interventional

Enrollment (Actual)

106

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

  • United Kingdom
    • Merseyside
      • Southport, Merseyside, United Kingdom, PR8 3NS
        • Talita Cumi LTD.

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 Criteria:

  • Aged 18 years and over.
  • Used to running at least 5kms in the last 1 year.

Exclusion Criteria:

  • Are currently using a prescription orthotic.
  • Have any ongoing pain or deformity in the foot.
  • Have been advised by a doctor to not exercise due to a serious health condition.
  • Have undergone any surgery in the last 6 months.
  • Have undergone any surgery on the foot during lifetime.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Running with an Orthotic
Group A will receive an L700 Speed Orthotic (https://www.aetrex.com/running-orthotic/?lang=en_US) according to participants shoe size and will run with this Orthotic in the participants normal running shoes. The investigators will send an instruction sheet along with the Orthotic in the post, explaining how to use it. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. The group will be asked to run as normal over the 8-week trial period
Device: Aetrex L700 Speed orthotic
An orthotic insole to be inserted into running shoes. Features Aetrex Arch Support to help biomechanically align the body & help prevent common foot pain such as Plantar Fasciitis, Arch Pain, and Metatarsalgia. Helps prevent injury, alleviate discomfort and helps reduce fatigue while running
No Intervention: Running without an Orthotic
Group B will not be provided with the Orthotic and will run in the participants normal running shoes during the course of the study. The group will be asked to run as normal over the 8-week trial period. At the end of the study and following collection of data participants in Group B will also be provided with an L700 Speed Orthotic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in levels of comfort as assessed by a Visual Analogue Scale (VAS)
Time Frame: Up to 8 weeks
Participants will record Comfort on a self-report Visual analogue scale (VAS) of 0 to 10 scale where 0 is "No comfort" and 10 is "Maximum comfort"
Up to 8 weeks
Running Duration via a self report questionnaire
Time Frame: Up to 8 weeks
Participants will record run duration in Hours:Minutes
Up to 8 weeks
Running Distance via a self report questionnaire
Time Frame: Up to 8 weeks
Participants will record run distance in Kilometres/Miles.
Up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Running related Injuries
Time Frame: Once a week during the 8-week trial period.
Participants will report any running related injuries via a self-report questionnaire. A human model will be used to identify the area of pain. Further choices and information will be provided to the participant on common injuries to allow the identification of the injury. This is a binary measure to observe whether an injury was sustained or not.
Once a week during the 8-week trial period.

Collaborators and Investigators

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

Sponsor

Talita Cumi Ltd.

Collaborators

Aetrex Worldwide Inc

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)

July 23, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • FFPETFETS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication.

IPD Sharing Time Frame

The data will become available at the completion of the study on 31/12/2022. It will be available for other researchers indefinitely.

IPD Sharing Access Criteria

The non-identifiable data will be openly available as a supplementary document to the publication.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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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