HealthyNCT06715904

Sex Differences in Morton's Extension Application on Plantar Pressure Distribution in Different Foot Regions in Female and Male Patients Without Deformities: A Pre-Post Test Study

A study testing Womens with Morton´s Extension in people with Healthy, run by Mayuben Private Clinic at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Womens with Morton´s Extension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteSpain
Study dates: 28 Feb 2025to 5 Mar 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;

Show all 9Show fewer

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Anna Sanchez-Serena
Manresa, Barcelona, 28702

Other trials in Spain

About this study

Official title: Comparison of the Effect of a Morton's Extension on Plantar Pressure Distribution in Different Foot Regions in Female and Male Patients Without Deformities: 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 different effects producted by sex in footprint.

Read the 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 difference effects due by sex on each metatarsal head and rearfoot on its static footprint, and plantar pressures variables in dynamic footprint.

Conditions: Healthy
Being tested: Womens with Morton´s Extension
Keywords: metatarsalgia, Foot, orthopedics, women
Medical subject headings: Metatarsalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Womens with Morton´s ExtensionOther
Also called Orthopaedics
Morton extension application

Study groups in NCT06715904
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Womens with Morton´s Extension

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 20255 Mar 2025

First posted4 Dec 2024
Study start28 Feb 2025
Primary completion1 Mar 2025
Study completion5 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Sex research
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06715904
Sponsor's protocol ID: 20/235(B)-E
Status last verified: Mar 2025
First submitted: 29 Nov 2024
Last updated: 6 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effect of a Morton's Extension on Plantar Pressure Distribution in Different Foot Regions in Female and Male Patients Without Deformities: A Pre-Post Test Study
ClinicalTrials.gov ID: NCT06715904
Acronym / sponsor ID: 20/235(B)-E
Conditions: Healthy
Keywords: metatarsalgia, Foot, orthopedics, women
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Mayuben Private ClinicUniversity, hospital or other
Collaborators: Universidad Complutense de Madrid
Study start: 28 Feb 2025 (actual)
Primary completion: 1 Mar 2025 (actual)
Study completion: 5 Mar 2025 (actual)
First posted: 4 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Sex research

Arm	Type	Receives
Women	Experimental	Other: Womens with Morton´s ExtensionA 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.
Men	Experimental	Other: Womens with Morton´s ExtensionA 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Womens with Morton´s ExtensionAlso: OrthopaedicsMorton extension application	Other	Men, Women

Primary outcome

Before Morton Extension Medium pressure
Time frame: 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.
Extension Maximum pressure
Time frame: 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.
After Morton Extension Medium pressure
Time frame: 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.
After Morton Extension Maximum pressure
Time frame: 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.
Before Morton Extension Medium pressure
Time frame: Through study completion, an average of 1 week
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.
Before Morton Extension Maximum pressure
Time frame: Through study completion, an average of 1 week
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.
After Morton Extension Medium pressure
Time frame: Through study completion, an average of 1 week
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.
After Morton Extension Maximum pressure
Time frame: Through study completion, an average of 1 week
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Womens with Morton´s Extension in people with Healthy, run by Mayuben Private Clinic at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Before Morton Extension Medium pressure (time frame: Through study completion, an average of 1 week.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06715904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.