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.

• Sponsor: Mayuben Private Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT05879094
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Actual Duration (Days): 4
• Patients Per Site Per Month: 190.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Other: Morton extension	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: May 29, 2023
• Actual Primary Completion Date: May 31, 2023
• Actual Study Completion Date: Jun 2, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Before Morton Extension Medium pressure [Through study completion, an average of 1 week]

   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.

2. Before Morton Extension Maximum pressure [Through study completion, an average of 1 week]

   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.

3. After Morton Extension Medium pressure [Through study completion, an average of 1 week]

   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.

4. After Morton Extension Maximum pressure [Through study completion, an average of 1 week]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eva María Martínez-Jimenez	Madrid		Spain	28040

Sponsors and Collaborators

• Mayuben Private Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EVA MARIA MARTÍNEZ JIMENEZ, Head of Podiatry, Principal Investigator, and Physiotherapist, Mayuben Private Clinic
• ClinicalTrials.gov Identifier: NCT05879094
• Other Study ID Numbers: 20/235-E
• First Posted: May 30, 2023
• Last Update Posted: Jun 5, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by EVA MARIA MARTÍNEZ JIMENEZ, Head of Podiatry, Principal Investigator, and Physiotherapist, Mayuben Private Clinic: metatarsalgia; foot; orthopedics
• Additional relevant MeSH terms: Congenital Abnormalities

Study Results

No Results Posted as of Jun 5, 2023