NCT05879094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 29, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

2 days

First QC Date

May 18, 2023

Last Update Submit

June 2, 2023

Conditions

Keywords

metatarsalgiafootorthopedics

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Morton extension

EXPERIMENTAL

Experimental group con Morton Extension application

Other: Morton extension

Interventions

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.

Morton extension

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eva María Martínez-Jimenez

Madrid, 28040, Spain

Location

Related Publications (1)

  • Sanchez-Serena A, Losa-Iglesias ME, Becerro-de-Bengoa-Vallejo R, Morales-Ponce A, Soriano-Medrano A, Perez-Boal E, Grande-Del-Arco J, Casado-Hernandez I, Martinez-Jimenez EM. Orthopaedic Simulation of a Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients without Deformity: A Pre-Post-Test Study. Diagnostics (Basel). 2023 Sep 28;13(19):3087. doi: 10.3390/diagnostics13193087.

MeSH Terms

Conditions

Metatarsalgia

Condition Hierarchy (Ancestors)

Foot DiseasesMusculoskeletal DiseasesJoint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eva María Martínez-Jimenez, PhD

    Mayuben Private Clinic

    PRINCIPAL INVESTIGATOR

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
Head of Podiatry, Principal Investigator, and Physiotherapist

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 30, 2023

Study Start

May 29, 2023

Primary Completion

May 31, 2023

Study Completion

June 2, 2023

Last Updated

June 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations