Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
106 participants
INTERVENTIONAL
2021-07-23
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
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
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.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Used to running at least 5kms in the last 1 year.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Aetrex Worldwide Inc
INDUSTRY
Talita Cumi Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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George Ampat, MBBS, MS, FRCS
Role: PRINCIPAL_INVESTIGATOR
Talita Cumi Ltd.
Locations
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Talita Cumi LTD.
Southport, Merseyside, United Kingdom
Countries
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References
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Collier R. Orthotics work in mysterious ways. CMAJ. 2011 Mar 8;183(4):416-7. doi: 10.1503/cmaj.109-3802. Epub 2011 Feb 14. No abstract available.
Yamato TP, Saragiotto BT, Lopes AD. A consensus definition of running-related injury in recreational runners: a modified Delphi approach. J Orthop Sports Phys Ther. 2015 May;45(5):375-80. doi: 10.2519/jospt.2015.5741. Epub 2015 Mar 26.
Lindorfer J, Kroll J, Schwameder H. Comfort assessment of running footwear: Does assessment type affect inter-session reliability? Eur J Sport Sci. 2019 Mar;19(2):177-185. doi: 10.1080/17461391.2018.1502358. Epub 2018 Jul 25.
van Gent RN, Siem D, van Middelkoop M, van Os AG, Bierma-Zeinstra SM, Koes BW. Incidence and determinants of lower extremity running injuries in long distance runners: a systematic review. Br J Sports Med. 2007 Aug;41(8):469-80; discussion 480. doi: 10.1136/bjsm.2006.033548. Epub 2007 May 1.
Kemler E, Blokland D, Backx F, Huisstede B. Differences in injury risk and characteristics of injuries between novice and experienced runners over a 4-year period. Phys Sportsmed. 2018 Nov;46(4):485-491. doi: 10.1080/00913847.2018.1507410. Epub 2018 Aug 21.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Link to Aetrex website, who produce and provide the orthotic insoles
Other Identifiers
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FFPETFETS001
Identifier Type: -
Identifier Source: org_study_id
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