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.

Healthy Subjects Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05879094
• Other study ID #: 20/235-E
• Status: Completed
• Phase: N/A
• Start date: May 29, 2023
• Est. completion date: June 2, 2023

Study information

• Verified date: June 2023
• Source: Mayuben Private Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Healthy Subjects

Intervention

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.

Locations

Country	Name	City	State
Spain	Eva María Martínez-Jimenez	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Mayuben Private Clinic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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