Sex Differences in Morton's Extension Application on Plantar Pressure Distribution in Different Foot Regions in Female and Male Patients Without Deformities: A Pre-Post Test Study

Comparison of the Effect of a Morton's Extension on Plantar Pressure Distribution in Different Foot Regions in Female and Male Patients Without Deformities: A Pre-Post Test Study

The aim of this study is to simulate the orthopedic treatment called Morton's extension on non-deformed patients to check the different effects producted by sex in footprint.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Womens with Morton´s Extension

Detailed Description

The objective of this study is to perform an assimilation of the orthopedic treatment called morton extension on non-deformed patients to verify the difference effects due by sex on each metatarsal head and rearfoot on its static footprint, and plantar pressures variables in dynamic footprint.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Manresa, Barcelona, Spain, 28702
      • Anna Sanchez-Serena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• no history of trauma to the foot;
• the presence of at least 10° of dorsiflexion at the ankle with the knee fully dorsiflexed;
• unrestricted motion of the functional subtalar joint of 30°;
• unrestricted motion along the longitudinal axis of the midtarsal joint of 15°;
• unrestricted nonweight-bearing motion of the first ray of at least 8 mm;
• greater than 50° of dorsiflexion of the hallux to the first metatarsal bisection during nonweight-bearing;
• age greater than 18 years and younger than 60 years;
• at the time of data collection, no lower limb dysfunction or chronic injury; and
• no evidence of a non-fixed deformity at first metatarsophalangeal and first metatarsal cuneiform joints.

Exclusion Criteria:

• plantar corns and calluses,
• hallux valgus and lesser toe deformities,
• diabetes,
• any abnormality in the lower extremity that may affect gait.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women; A Morton extension with a height of 5 mm was insert from the proximal area of the first metatarsal head to the base of the proximal phalanx of the Hallux.	Other: Womens with Morton´s Extension; Morton extension application; Other Names: Orthopaedics
Experimental: Men; A Morton extension with a height of 5 mm was insert from the proximal area of the first metatarsal head to the base of the proximal phalanx of the Hallux.	Other: Womens with Morton´s Extension; Morton extension application; Other Names: Orthopaedics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
After Morton Extension Maximum pressure	Static footprint will measure maximum plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.	Through study completion, an average of 1 week
Before Morton Extension Medium pressure	Static footprint will measure medium plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.	Through study completion, an average of 1 week.
Extension Maximum pressure	Static footprint will measure maximum plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.	Through study completion, an average of 1 week.
After Morton Extension Medium pressure	Static footprint will measure medium plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.	Through study completion, an average of 1 week.
Before Morton Extension Medium pressure	Dynamic footprint will measure medium plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.	Through study completion, an average of 1 week
Before Morton Extension Maximum pressure	Dynamic footprint will measure maximum plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.	Through study completion, an average of 1 week
After Morton Extension Medium pressure	Dynamic footprint will measure medium plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.	Through study completion, an average of 1 week
After Morton Extension Maximum pressure	Dynamic footprint will measure maximum plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.	Through study completion, an average of 1 week

Collaborators and Investigators

• Sponsor: Mayuben Private Clinic
• Collaborators: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 5, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: women; Foot; metatarsalgia; orthopedics
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 20/235(B)-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No