Orthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: 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 effects on each metatarsal head on its static footprint.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Morton 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 effects on each metatarsal head on its static footprint, specifically the mean pressures and before and after the application of the morton extension.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Eva María Martínez-Jiménez

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 MTP 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morton extension; Experimental group con Morton Extension application	Other: Morton extension; 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 of the subjects' bare feet using a paper bandage. The material, shape, size, and thickness of the Morton Extension were the same.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Before 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
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
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

Collaborators and Investigators

• Sponsor: Mayuben Private Clinic
• Investigators: Principal Investigator: Eva María Martínez-Jimenez, PhD, Mayuben Private Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: foot; metatarsalgia; orthopedics
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 20/235-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