Pes PlanusCFONCT07723573
Comparing Effects of Custom Foot Orthotic Intervention to Foot-Core Training Protocol on Lower Extremity Kinematics in Runners With Pes Planus
A study testing Custom foot orthoses and Intrinsic foot muscle strengthening exercises in people with Pes Planus and Running Related Injuries, run by Dalhousie University at 1 site in Canada.
Trial summary
Running is a full body movement that requires the feet to support the body and absorb forces greater than the individual's body weight in a repeated fashion. If the musculoskeletal structures of the feet cannot withstand and disperse the force applied, injury and dysfunction will occur. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pes Planus, Running Related Injuries
- What is being tested?
- Custom foot orthoses and Intrinsic foot muscle strengthening exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy recreational runners
- aged 18-30 years old
- pes planus foot type as characterized by the Foot Posture Index
Who cannot join
- Individuals having any cardiovascular or neurological illnesses
- Individuals having any chronic musculoskeletal diseases such as rheumatoid arthritis or osteoarthritis
- Individuals who have suffered a running-related injury in the 6 months leading up to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jayde Corkum, B.Sc. contact
Canada1 site
School of Health and Human Performance
Halifax, Nova Scotia, B3H4R2
Christopher L MacLean, Ph.D., 6043519030, christopher.maclean@dal.ca
About this study
Running is a full body movement that requires the feet to support the body and absorb forces greater than the individual's body weight in a repeated fashion. If the musculoskeletal structures of the feet cannot withstand and disperse the force applied, injury and dysfunction will occur. Without the inherent support of the foot musculature, ligaments are strained, and bones of the foot and ankle must absorb all forces, directly. When the medial longitudinal arch cannot be supported, the entire structure collapses, causing the foot to pronate. These postural signs indicate pes planus, or flat feet. Custom foot orthoses (CFOs) are commonly used to manage pes planus and research within the last 25 years has not provided clear insight on how CFOs influence running mechanics of joints and segments proximal to the foot (knee and hip). Additionally, CFO intervention has not been compared to exercise programming that focuses on strengthening the muscles that provide the foot with intrinsic strength. This study will provide insight on how these two interventions may influence foot biomechanics in the pes planus foot. We are hopeful that our findings can help to inform rehabilitation professionals in how different interventions can alter biomechanical outcomes related to pes planus. Previous literature also commonly focuses on an aging or sedentary individuals, while this study will focus on young active participants with a pes planus foot type.
Healthy recreational runners between the ages of 18-35 years old with pes planus will be recruited to participate. Participants will be randomly appointed to one of two groups: 1) the CFO group will wear CFOs for 8 weeks; and 2) the exercise group will be assigned an exercise protocol to complete each day for eight weeks. Participation will consist of completion of a prolonged run protocol in two testing sessions, pre- and post-intervention, and compliance to their assigned intervention. Three-dimensional kinematic data will be collected using a 10-camera motion capture system (Qualisys). For each data collection session, passive reflective markers will be placed on the participant both lower extremities, and participants will be instrumented with a heart rate (HR) monitor. The prolonged run protocol will consist of a five-minute warm-up phase, where participants will choose a comfortable running speed, with a desired HR at approximately 120 beats per minute (bpm). After the warm-up, participants will be permitted to stretch if desired, as they would before a typical run. Once ready, the participant will select a comfortable running pace that best represents their typical training pace. Running speed will be intermittently increased. A member of the research team will monitor the participant throughout the trial to check their HR, ask them to rate their perceived exertion on Borg's RPE scale (which will be displayed in front of them), and ask them to rate any pain they may be feeling on a scale from 1-10. The prolonged run protocol will end when any of the following occurs: 1) participant HR reaches 85% of their HR max, 2) participant rates the activity a score of 17 (very hard) on Borg's RPE Scale, or 3) the participant gives a 7/10 pain rating. Once the protocol has ended, participants will enter a cool-down phase where they will jog or walk until HR lowers. Participants will be able to stretch again following the protocol if desired.
- Conditions
- Pes Planus, Running Related Injuries
- Being tested
- Custom foot orthoses, Intrinsic foot muscle strengthening exercises
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom foot orthosesDevice
Custom foot orthoses constructed from a neutral suspension cast
Intrinsic foot muscle strengthening exercisesBehavioural
An 8 week, intrinsic foot muscle strengthening program focusing on the intrinsic foot muscles that stabilize the medial longitudinal arch of the foot.
| Study group | Role | What they receive |
|---|---|---|
| Pes planus | Experimental | Individuals who have been classified as having a pes planus foot type using the Foot Posture Index. Receives: Device: Custom foot orthoses; Behavioral: Intrinsic foot muscle strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standing static, arch height
The static standing arch height will be calculated using motion capture.
Measured: From enrollment to the end of the interventions at 8 weeks
Maximum three dimensional joint angles of the hip, knee and ankle
Joint angle maxima for the hip, knee and ankle during the stance phase of running.
Measured: From enrollment to the end of each intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pes PlanusStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher MacLean, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723573
- Sponsor's protocol ID
- DAL_Corkum & MacLean
- Acronym
- CFO
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MacLean C, Davis IM, Hamill J. Influence of a custom foot orthotic intervention on lower extremity dynamics in healthy runners. Clin Biomech (Bristol). 2006 Jul;21(6):623-30. doi: 10.1016/j.clinbiomech.2006.01.005. Epub 2006 Apr 5.
PubMed 16603287Maclean CL, Davis IS, Hamill J. Influence of running shoe midsole composition and custom foot orthotic intervention on lower extremity dynamics during running. J Appl Biomech. 2009 Feb;25(1):54-63. doi: 10.1123/jab.25.1.54.
PubMed 19299830MacLean CL, Davis IS, Hamill J. Short- and long-term influences of a custom foot orthotic intervention on lower extremity dynamics. Clin J Sport Med. 2008 Jul;18(4):338-43. doi: 10.1097/MJT.0b013e31815fa75a.
PubMed 18614885MacLean CL, van Emmerik R, Hamill J. Influence of custom foot orthotic intervention on lower extremity intralimb coupling during a 30-minute run. J Appl Biomech. 2010 Nov;26(4):390-9. doi: 10.1123/jab.26.4.390.
PubMed 21245498
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effects of Custom Foot Orthotic Intervention to Foot-Core Training Protocol on Lower Extremity Kinematics in Runners With Pes Planus
- ClinicalTrials.gov ID
- NCT07723573
- Acronym / sponsor ID
- CFO / DAL_Corkum & MacLean
- Conditions
- Pes Planus, Running Related Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 23 Jul 2026 (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.
Running is a full body movement that requires the feet to support the body and absorb forces greater than the individual's body weight in a repeated fashion. If the musculoskeletal structures of the feet cannot withstand and disperse the force applied, injury and dysfunction will occur. Without the inherent support of the foot musculature, ligaments are strained, and bones of the foot and ankle must absorb all forces, directly. When the medial longitudinal arch cannot be supported, the entire structure collapses, causing the foot to pronate. These postural signs indicate pes planus, or flat feet. Custom foot orthoses (CFOs) are commonly used to manage pes planus and research within the last 25 years has not provided clear insight on how CFOs influence running mechanics of joints and segments proximal to the foot (knee and hip). Additionally, CFO intervention has not been compared to exercise programming that focuses on strengthening the muscles that provide the foot with intrinsic strength. This study will provide insight on how these two interventions may influence foot biomechanics in the pes planus foot. We are hopeful that our findings can help to inform rehabilitation professionals in how different interventions can alter biomechanical outcomes related to pes planus. Previous literature also commonly focuses on an aging or sedentary individuals, while this study will focus on young active participants with a pes planus foot type.
Healthy recreational runners between the ages of 18-35 years old with pes planus will be recruited to participate. Participants will be randomly appointed to one of two groups: 1) the CFO group will wear CFOs for 8 weeks; and 2) the exercise group will be assigned an exercise protocol to complete each day for eight weeks. Participation will consist of completion of a prolonged run protocol in two testing sessions, pre- and post-intervention, and compliance to their assigned intervention. Three-dimensional kinematic data will be collected using a 10-camera motion capture system (Qualisys). For each data collection session, passive reflective markers will be placed on the participant both lower extremities, and participants will be instrumented with a heart rate (HR) monitor. The prolonged run protocol will consist of a five-minute warm-up phase, where participants will choose a comfortable running speed, with a desired HR at approximately 120 beats per minute (bpm). After the warm-up, participants will be permitted to stretch if desired, as they would before a typical run. Once ready, the participant will select a comfortable running pace that best represents their typical training pace. Running speed will be intermittently increased. A member of the research team will monitor the participant throughout the trial to check their HR, ask them to rate their perceived exertion on Borg's RPE scale (which will be displayed in front of them), and ask them to rate any pain they may be feeling on a scale from 1-10. The prolonged run protocol will end when any of the following occurs: 1) participant HR reaches 85% of their HR max, 2) participant rates the activity a score of 17 (very hard) on Borg's RPE Scale, or 3) the participant gives a 7/10 pain rating. Once the protocol has ended, participants will enter a cool-down phase where they will jog or walk until HR lowers. Participants will be able to stretch again following the protocol if desired.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pes planus | Experimental | Device: Custom foot orthoses, Behavioral: Intrinsic foot muscle strengthening exercisesIndividuals who have been classified as having a pes planus foot type using the Foot Posture Index. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy recreational runners
- aged 18-30 years old
- pes planus foot type as characterized by the Foot Posture Index
Key exclusion criteria (3 listed)
- Individuals having any cardiovascular or neurological illnesses
- Individuals having any chronic musculoskeletal diseases such as rheumatoid arthritis or osteoarthritis
- Individuals who have suffered a running-related injury in the 6 months leading up to the study
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 |
|---|---|---|
| Custom foot orthosesCustom foot orthoses constructed from a neutral suspension cast | Device | Pes planus |
| Intrinsic foot muscle strengthening exercisesAn 8 week, intrinsic foot muscle strengthening program focusing on the intrinsic foot muscles that stabilize the medial longitudinal arch of the foot. | Behavioural | Pes planus |
Primary outcome
Standing static, arch height
Time frame: From enrollment to the end of the interventions at 8 weeks
The static standing arch height will be calculated using motion capture.
Maximum three dimensional joint angles of the hip, knee and ankle
Time frame: From enrollment to the end of each intervention at 8 weeks
Joint angle maxima for the hip, knee and ankle during the stance phase of running.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 16603287MacLean C, Davis IM, Hamill J. Influence of a custom foot orthotic intervention on lower extremity dynamics in healthy runners. Clin Biomech (Bristol). 2006 Jul;21(6):623-30. doi: 10.1016/j.clinbiomech.2006.01.005. Epub 2006 Apr 5.
- Background: PubMed 19299830Maclean CL, Davis IS, Hamill J. Influence of running shoe midsole composition and custom foot orthotic intervention on lower extremity dynamics during running. J Appl Biomech. 2009 Feb;25(1):54-63. doi: 10.1123/jab.25.1.54.
- Background: PubMed 18614885MacLean CL, Davis IS, Hamill J. Short- and long-term influences of a custom foot orthotic intervention on lower extremity dynamics. Clin J Sport Med. 2008 Jul;18(4):338-43. doi: 10.1097/MJT.0b013e31815fa75a.
- Background: PubMed 21245498MacLean CL, van Emmerik R, Hamill J. Influence of custom foot orthotic intervention on lower extremity intralimb coupling during a 30-minute run. J Appl Biomech. 2010 Nov;26(4):390-9. doi: 10.1123/jab.26.4.390.
- Individual participant dataSharing planned: No
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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.
Jayde Corkum, B.Sc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom foot orthoses and Intrinsic foot muscle strengthening exercises in people with Pes Planus and Running Related Injuries, run by Dalhousie University at 1 site in Canada.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Jul 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher L MacLean, Ph.D. (6043519030, christopher.maclean@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standing static, arch height (time frame: From enrollment to the end of the interventions at 8 weeks). The study lists 2 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 NCT07723573, which also lists 4 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 23 Jul 2026.