Comparing Effects of Custom Foot Orthotic Intervention to Foot-Core Training Protocol on Lower Extremity Kinematics in Runners With Pes Planus

NCT07723573 | Not Yet Recruiting

• 1 other identifier: DAL_Corkum & MacLean
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Standing static, arch height

  The static standing arch height will be calculated using motion capture.

  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.

  From enrollment to the end of each intervention at 8 weeks

Study Arms (1)

Pes planus

EXPERIMENTAL

Individuals who have been classified as having a pes planus foot type using the Foot Posture Index.

Device: Custom foot orthoses; Behavioral: Intrinsic foot muscle strengthening exercises

Interventions

Custom foot orthoses DEVICE

Custom foot orthoses constructed from a neutral suspension cast

Pes planus

Intrinsic foot muscle strengthening exercises BEHAVIORAL

An 8 week, intrinsic foot muscle strengthening program focusing on the intrinsic foot muscles that stabilize the medial longitudinal arch of the foot.

Pes planus

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy recreational runners
• aged 18-30 years old
• pes planus foot type as characterized by the Foot Posture Index

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

School of Health and Human Performance

Halifax, Nova Scotia, B3H4R2, Canada

Location

Related Publications (4)

• 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.

  PMID: 16603287 BACKGROUND

• Maclean 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.

  PMID: 19299830 BACKGROUND

• MacLean 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.

  PMID: 18614885 BACKGROUND

• MacLean 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.

  PMID: 21245498 BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Christopher L MacLean, Ph.D.

CONTACT

6043519030; christopher.maclean@dal.ca

Jayde Corkum, B.Sc.

CONTACT

jaydecorkum@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)