Orthotics and Running
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
1 other identifier
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedStudy Start
First participant enrolled
July 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedOctober 21, 2022
October 1, 2022
1.1 years
May 14, 2021
October 20, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Running related Injuries
Once a week during the 8-week trial period.
Study Arms (2)
Running with an Orthotic
ACTIVE COMPARATORGroup 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
Running without an Orthotic
NO INTERVENTIONGroup 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.
Interventions
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
You may qualify if:
- Aged 18 years and over.
- Used to running at least 5kms in the last 1 year.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Talita Cumi Ltd.lead
- Aetrex Worldwide Inccollaborator
Study Sites (1)
Talita Cumi LTD.
Southport, Merseyside, PR8 3NS, United Kingdom
Related Publications (12)
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.
PMID: 21324862BACKGROUNDYamato 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.
PMID: 25808527BACKGROUNDLindorfer 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.
PMID: 30044208BACKGROUNDvan 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.
PMID: 17473005RESULTKemler 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.
PMID: 30071170RESULTMundermann 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.
PMID: 11689747RESULTBonanno 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.
PMID: 29056595RESULTFranklyn-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.
PMID: 21041512RESULTvan 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.
PMID: 25706955RESULTYeung 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.
PMID: 21735382RESULTBonanno 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.
PMID: 27919918RESULTAmpat, 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.
RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
George Ampat, MBBS, MS, FRCS
Talita Cumi Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2021
First Posted
May 25, 2021
Study Start
July 23, 2021
Primary Completion
August 31, 2022
Study Completion
December 31, 2022
Last Updated
October 21, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.