Clinical trial NCT04901442: Orthotics and Running
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Running Comfort
Running Speed
Occurence of Running Related Injuries
Lead sponsor: Talita Cumi Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Aetrex Worldwide Inc
First posted: 2021-05-25
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in levels of comfort as assessed by a Visual Analogue Scale (VAS)
timeFrame: Up to 8 weeks
measure: Running Duration via a self report questionnaire
timeFrame: Up to 8 weeks
measure: Running Distance via a self report questionnaire
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Running related Injuries
timeFrame: Once a week during the 8-week trial period.
Other outcomes:
Locations:
city: Southport
country: United Kingdom
facility: Talita Cumi LTD.
state: Merseyside
Study officials:
affiliation: Talita Cumi Ltd.
name: George Ampat, MBBS, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mundermann A, Stefanyshyn DJ, Nigg BM. Relationship between footwear comfort of shoe inserts and anthropometric and sensory factors. Med Sci Sports Exerc. 2001 Nov;33(11):1939-45. doi: 10.1097/00005768-200111000-00021.
citation: Bonanno DR, Murley GS, Munteanu SE, Landorf KB, Menz HB. Effectiveness of foot orthoses for the prevention of lower limb overuse injuries in naval recruits: a randomised controlled trial. Br J Sports Med. 2018 Mar;52(5):298-302. doi: 10.1136/bjsports-2017-098273. Epub 2017 Oct 22.
citation: Franklyn-Miller A, Wilson C, Bilzon J, McCrory P. Foot orthoses in the prevention of injury in initial military training: a randomized controlled trial. Am J Sports Med. 2011 Jan;39(1):30-7. doi: 10.1177/0363546510382852. Epub 2010 Nov 1.
citation: van der Worp MP, ten Haaf DS, van Cingel R, de Wijer A, Nijhuis-van der Sanden MW, Staal JB. Injuries in runners; a systematic review on risk factors and sex differences. PLoS One. 2015 Feb 23;10(2):e0114937. doi: 10.1371/journal.pone.0114937. eCollection 2015.
citation: Yeung SS, Yeung EW, Gillespie LD. Interventions for preventing lower limb soft-tissue running injuries. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001256. doi: 10.1002/14651858.CD001256.pub2.
citation: Bonanno DR, Landorf KB, Munteanu SE, Murley GS, Menz HB. Effectiveness of foot orthoses and shock-absorbing insoles for the prevention of injury: a systematic review and meta-analysis. Br J Sports Med. 2017 Jan;51(2):86-96. doi: 10.1136/bjsports-2016-096671. Epub 2016 Dec 5.
citation: 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.