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Orthotics and Running

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ClinicalTrials.gov Identifier: NCT04901442
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : July 29, 2021
Sponsor:
Collaborator:
Aetrex Worldwide Inc
Information provided by (Responsible Party):
Talita Cumi Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Running Comfort Running Speed Occurence of Running Related Injuries Device: Aetrex L700 Speed orthotic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : July 23, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022

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.



Primary Outcome Measures :
  1. 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"

  2. Running Duration via a self report questionnaire [ Time Frame: Up to 8 weeks ]
    Participants will record run duration in Hours:Minutes

  3. Running Distance via a self report questionnaire [ Time Frame: Up to 8 weeks ]
    Participants will record run distance in Kilometres/Miles.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT04901442


Contacts
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Contact: George Ampat, MBBS, MS, FRCS 07871590593 geampat@gmail.com
Contact: Jonathan Sims, BSc 01704 808703 research@ampat.co.uk

Locations
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United Kingdom
Talita Cumi LTD. Recruiting
Southport, Merseyside, United Kingdom, PR8 3NS
Contact: George Ampat, MBBS, MS, FRCS    07871 590593    geampat@gmail.com   
Contact: Jonathan M Sims, BSc    01704808703    research@ampat.co.uk   
Principal Investigator: George Ampat, MBBS, MS, FRCS         
Sub-Investigator: Jonathan Sims, BSc         
Sub-Investigator: Alice Fortune         
Sub-Investigator: Shaik Ashraf         
Sponsors and Collaborators
Talita Cumi Ltd.
Aetrex Worldwide Inc
Investigators
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Principal Investigator: George Ampat, MBBS, MS, FRCS Talita Cumi Ltd.
Additional Information:
Publications of Results:
Ampat, G., R. Baxter, and F. Geoghegan. Pedobarograph based prefabricated orthotics reduces self-reported minor injuries and improves comfort whilst running. MOJ Orthop Rheumatol 12.1 (2020): 1-5.

Other Publications:
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Responsible Party: Talita Cumi Ltd.
ClinicalTrials.gov Identifier: NCT04901442    
Other Study ID Numbers: FFPETFETS001
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
Access Criteria: The non-identifiable data will be openly available as a supplementary document to the publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries