Healthy SubjectsNCT05879094
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.
A study testing Morton extension in people with Healthy Subjects, run by Mayuben Private Clinic at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Morton extension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 29 May 2023to 2 Jun 2023
- 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 MTP 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.
About this study
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.
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 effects on each metatarsal head on its static footprint, specifically the mean pressures and before and after the application of the morton extension.
- Conditions
- Healthy Subjects
- Being tested
- Morton extension
- Keywords
- metatarsalgia, foot, orthopedics
- Medical subject headings
- Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morton extensionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Morton extension | Experimental | Experimental group con Morton Extension application Receives: Other: Morton 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
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.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start29 May 2023
- Primary completion31 May 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayuben Private Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EVA MARIA MARTÍNEZ JIMENEZ, Mayuben Private Clinic
- Investigators
- Eva María Martínez-Jimenez, PhD, Principal investigator, Mayuben Private Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879094
- Sponsor's protocol ID
- 20/235-E
- Status last verified
- Jun 2023
- First submitted
- 18 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37835830
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05879094
- Acronym / sponsor ID
- 20/235-E
- Conditions
- Healthy Subjects
- Keywords
- metatarsalgia, foot, orthopedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayuben Private ClinicUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 30 May 2023 (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 effects on each metatarsal head on its static footprint.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morton extension | Experimental | Other: Morton extensionExperimental group con Morton Extension application |
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 |
|---|---|---|
| Morton 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 of the subjects' bare feet using a paper bandage. The material, shape, size, and thickness of the Morton Extension were the same. | Other | Morton extension |
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.
Before 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.
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.
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 5 Jun 2023.
- Derived from this study: PubMed 37835830Sanchez-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.
- 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.
Eva María Martínez-Jimenez, PhD principal investigator
Mayuben Private Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morton extension in people with Healthy Subjects, 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 5 Jun 2023. 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 4 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 NCT05879094, which also lists 1 linked publication.
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 5 Jun 2023.