Running ComfortNCT04901442
Orthotics and Running
A study testing Aetrex L700 Speed orthotic in people with Running Comfort and Running Speed, run by Talita Cumi Ltd. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Running Comfort, Running Speed, Occurence of Running Related Injuries
- What is being tested?
- Aetrex L700 Speed orthotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jul 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years and over.
- Used to running at least 5kms in the last 1 year.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Aetrex L700 Speed orthotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aetrex L700 Speed orthoticDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Running with an Orthotic | Active comparator | 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 Receives: Device: Aetrex L700 Speed orthotic |
| Running without an Orthotic | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: Up to 8 weeks
Running Duration via a self report questionnaire
Participants will record run duration in Hours:Minutes
Measured: Up to 8 weeks
Running Distance via a self report questionnaire
Participants will record run distance in Kilometres/Miles.
Measured: Up to 8 weeks
Secondary outcomes (1)
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.
Measured: Once a week during the 8-week trial period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start23 Jul 2021
- Primary completion31 Aug 2022
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Running ComfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talita Cumi Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aetrex Worldwide Inc
- Responsible party
- Sponsor
- Investigators
- George Ampat, MBBS, MS, FRCS, Principal investigator, Talita Cumi Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901442
- Sponsor's protocol ID
- FFPETFETS001
- Status last verified
- Oct 2022
- First submitted
- 14 May 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 21324862Yamato 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.
PubMed 25808527Lindorfer 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.
PubMed 30044208van 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.
PubMed 17473005Kemler 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.
PubMed 30071170Mundermann 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.
PubMed 11689747Bonanno 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.
PubMed 29056595Franklyn-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.
PubMed 21041512van 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.
PubMed 25706955Yeung SS, Yeung EW, Gillespie LD. Interventions for preventing lower limb soft-tissue running injuries. Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD001256. doi: 10.1002/14651858.CD001256.pub2.
PubMed 21735382Bonanno 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.
PubMed 27919918Ampat, 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04901442
- Acronym / sponsor ID
- FFPETFETS001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Talita Cumi Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Aetrex Worldwide Inc
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Running with an Orthotic | Active comparator | Device: Aetrex L700 Speed orthoticGroup 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years and over.
- Used to running at least 5kms in the last 1 year.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aetrex L700 Speed orthoticAn 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 | Device | Running with an Orthotic |
Primary outcome
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.
1 secondary outcome
Running related Injuries
Time frame: Once a week during the 8-week trial period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Background: PubMed 21324862Collier 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.
- Background: PubMed 25808527Yamato 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.
- Background: PubMed 30044208Lindorfer 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.
- Results publication: PubMed 17473005van 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.
- Results publication: PubMed 30071170Kemler 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.
- Results publication: PubMed 11689747Mundermann 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.
- Results publication: PubMed 29056595Bonanno 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.
- Results publication: PubMed 21041512Franklyn-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.
- Results publication: PubMed 25706955van 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.
- Results publication: PubMed 21735382Yeung SS, Yeung EW, Gillespie LD. Interventions for preventing lower limb soft-tissue running injuries. Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD001256. doi: 10.1002/14651858.CD001256.pub2.
- Results publication: PubMed 27919918Bonanno 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.
- Results publicationAmpat, 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.
- Link to government statistics on sports participation in EnglandLink provided by the sponsor.
- Link to Aetrex website, who produce and provide the orthotic insolesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Ampat, MBBS, MS, FRCS principal investigator
Talita Cumi Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aetrex L700 Speed orthotic in people with Running Comfort and Running Speed, run by Talita Cumi Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in levels of comfort as assessed by a Visual Analogue Scale (VAS) (time frame: Up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901442, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.