NCT06715904

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2025

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

November 29, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

1 day

First QC Date

November 29, 2024

Last Update Submit

March 5, 2025

Conditions

Healthy

Keywords

metatarsalgiaFootorthopedicswomen

Outcome Measures

Primary Outcomes (8)

  • 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.

  • 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

    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

Study Arms (2)

Women

EXPERIMENTAL

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

Men

EXPERIMENTAL

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

Interventions

Womens with Morton´s ExtensionOTHER

Morton extension application

Also known as: Orthopaedics
MenWomen

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailscomparative study by sex of Morton´s extension effects
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 metatarsophalangeal 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)

Anna Sanchez-Serena

Manresa, Barcelona, 28702, Spain

Location

MeSH Terms

Conditions

Metatarsalgia

Interventions

Orthopedic Procedures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Sex research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Podiatry, Principal Investigator, and Physiotherapist.

Study Record Dates

First Submitted

November 29, 2024

First Posted

December 4, 2024

Study Start

February 28, 2025

Primary Completion

March 1, 2025

Study Completion

March 5, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)