Orthotics and Running
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| ClinicalTrials.gov Identifier: NCT04901442 |
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Recruitment Status :
Recruiting
First Posted : May 25, 2021
Last Update Posted : July 29, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Running Comfort Running Speed Occurence of Running Related Injuries | Device: Aetrex L700 Speed orthotic | Not Applicable |
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 (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 |
|---|---|
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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
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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 |
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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.
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- 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"
- Running Duration via a self report questionnaire [ Time Frame: Up to 8 weeks ]Participants will record run duration in Hours:Minutes
- Running Distance via a self report questionnaire [ Time Frame: Up to 8 weeks ]Participants will record run distance in Kilometres/Miles.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
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
| Contact: George Ampat, MBBS, MS, FRCS | 07871590593 | geampat@gmail.com | |
| Contact: Jonathan Sims, BSc | 01704 808703 | research@ampat.co.uk |
| 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 | |
| Principal Investigator: | George Ampat, MBBS, MS, FRCS | Talita Cumi Ltd. |
Publications of Results:
Other Publications:
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Wounds and Injuries |