Orthotics and Running

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Running Comfort, Running Speed, Occurence of Running Related Injuries

Intervention / Treatment
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* Device: Aetrex L700 Speed orthotic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Running with an Orthotic<br>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<br>* 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<br>|
| No Intervention: Running without an Orthotic<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of comfort as assessed by a Visual Analogue Scale (VAS) | 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 | Participants will record run duration in Hours:Minutes | Up to 8 weeks | 
| Running Distance via a self report questionnaire | Participants will record run distance in Kilometres/Miles. | Up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Running related Injuries | 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. |