Healthy SubjectsNCT06526715
Balance Effects of Morton´s Extension in Flat Foot
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 flat foot patients to check balance effects in standing position. Read more about this study
- Who is it for?
- Ages 18 to 40 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
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jul 2024to 6 Aug 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women and men aged 18 to 30 with flexible flat feet.
Who cannot join
- Participants who have had any previous limb surgery, and/or previous lower limb trauma within the last year
- Uncorrected hearing or visual impairment.
- Lumbar pathology with radicular involvement.
- Pregnancy.
- Healthy participants performing strenuous exercise.
- Diagnosed active or inactive rheumatic or inflammatory disease.
Show all 12Show fewer
- Participants consuming alcohol within 24 hours prior to recording or stimulants 6 hours prior to testing (e.g. caffeine).
- Participants who have a history of injury with residual lower extremity symptoms within the past year.
- Participants with evidence of a leg length discrepancy (difference in distance from the anterior superior iliac spine to the superior iliac spine at the surface of the most prominent aspect of the medial malleolus) of more than 1 cm 19
- Having at least 15 degrees of ankle dorsiflexion.
- Participants with evidence of balance deficit, as determined through oral questioning about falls and by use of the Balance Evaluation Systems Test (BESTest).
- Participants with neurological pathology with lower limb deformities, sensory-motor disturbances, neuromuscular pathology, or neurovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balance Effects of Morton´s Extension in Flat Foot. A Pre-post-test Study.
The aim of this study is to simulate the orthopedic treatment called Morton's extension on flat foot patients to check balance effects in standing position.
Read the detailed description
The objective of this study is to perform an assimilation of the orthopedic treatment called morton extension on flat foot patients to verify the balance with stabilometry study.
- Conditions
- Healthy Subjects
- Being tested
- Morton extension
- Keywords
- balance, Foot, Orthopedics
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.s extension treatment | Experimental | Appliation of Morton´s extension treatment simulation Receives: Other: Morton extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length in millimetres of the centre of pressures. Untreated
Length of the centre of pressures described in millimetres.
Measured: Through study completion, an average of 4 days
Area of the ellipse. Untreated
Area of the ellipse in square millimeters.
Measured: Through study completion, an average of 4 days
Inclination of the ellipse in degrees.Untreated
Inclination of the ellipse generated by the centre of pressures in 30 seconds in degrees.
Measured: Through study completion, an average of 4 days
Length-area ratio. Untreated
Fraction of the length of the ellipse between the surface of the ellipse in millimetres.
Measured: Through study completion, an average of 4 days
Delta x. Untreated
Displacement on the x-axis within the ellipse calculated from the movements of the barycentre. In millimetres.
Measured: Through study completion, an average of 4 days
Delta y. Untreated
Displacement on the y-axis within the ellipse calculated based on the movements of the barycentre. In millimetres.
Measured: Through study completion, an average of 4 days
Displacement on the major axis or y-axis. Untreated
Displacement in millimetres of the y-axis.
Measured: Through study completion, an average of 4 days
Displacement on the minor axis or x-axis. Untreated
Displacement in millimetres of the y-axis.
Measured: Through study completion, an average of 4 days
Maximum oscillation. Untreated
Measurement of the length in millimetres of the maximum oscillations.
Measured: Through study completion, an average of 4 days
Minimum oscillation in millimetres. Untreated
Measurement of the length in millimetres of the minimum oscillations
Measured: Through study completion, an average of 4 days
Length in millimetres of the centre of pressures with treatment
Length of the centre of pressures described in millimetres.
Measured: Through study completion, an average of 4 days
Area of the ellipse with treatment
Area of the ellipse in square millimeters.
Measured: Through study completion, an average of 4 days
Inclination of the ellipse in degrees with treatment
Inclination of the ellipse generated by the centre of pressures in 30 seconds in degrees.
Measured: Through study completion, an average of 4 days
Length-area ratio with treatment
Fraction of the length of the ellipse between the surface of the ellipse in millimetres.
Measured: Through study completion, an average of 4 days
Delta x with treatment
Displacement on the x-axis within the ellipse calculated from the movements of the barycentre. In millimetres.
Measured: Through study completion, an average of 4 days
Delta y with treatment
Displacement on the y-axis within the ellipse calculated based on the movements of the barycentre. In millimetres.
Measured: Through study completion, an average of 4 days
Displacement on the major axis or y-axis with treatment
Displacement in millimetres of the y-axis.
Measured: Through study completion, an average of 4 days
Displacement on the minor axis or x-axis with treatment
Displacement in millimetres of the y-axis.
Measured: Through study completion, an average of 4 days
Maximum oscillation with treatment
Measurement of the length in millimetres of the maximum oscillations.
Measured: Through study completion, an average of 4 days
Minimum oscillation in millimetres with treatment
Measurement of the length in millimetres of the minimum oscillations
Measured: Through study completion, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start30 Jul 2024
- Primary completion5 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayuben Private Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de León
- Responsible party
- Principal investigator, EVA MARIA MARTÍNEZ JIMENEZ, Universidad Complutense de Madrid
- Investigators
- Eva María Martínez Jiménez, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526715
- Sponsor's protocol ID
- 24/458-E
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Effects of Morton´s Extension in Flat Foot. A Pre-post-test Study.
- ClinicalTrials.gov ID
- NCT06526715
- Acronym / sponsor ID
- 24/458-E
- Conditions
- Healthy Subjects
- Keywords
- balance, Foot, Orthopedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mayuben Private ClinicUniversity, hospital or other
- Collaborators
- Universidad de León
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 30 Jul 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 flat foot patients to check balance effects in standing position.
Detailed description
The objective of this study is to perform an assimilation of the orthopedic treatment called morton extension on flat foot patients to verify the balance with stabilometry study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morton.s extension treatment | Experimental | Other: Morton extensionAppliation of Morton´s extension treatment simulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women and men aged 18 to 30 with flexible flat feet.
Key exclusion criteria (12 listed)
- Participants who have had any previous limb surgery, and/or previous lower limb trauma within the last year
- Uncorrected hearing or visual impairment.
- Lumbar pathology with radicular involvement.
- Pregnancy.
- Healthy participants performing strenuous exercise.
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.s extension treatment |
Primary outcome
Length in millimetres of the centre of pressures. Untreated
Time frame: Through study completion, an average of 4 days
Length of the centre of pressures described in millimetres.
Area of the ellipse. Untreated
Time frame: Through study completion, an average of 4 days
Area of the ellipse in square millimeters.
Inclination of the ellipse in degrees.Untreated
Time frame: Through study completion, an average of 4 days
Inclination of the ellipse generated by the centre of pressures in 30 seconds in degrees.
Length-area ratio. Untreated
Time frame: Through study completion, an average of 4 days
Fraction of the length of the ellipse between the surface of the ellipse in millimetres.
Delta x. Untreated
Time frame: Through study completion, an average of 4 days
Displacement on the x-axis within the ellipse calculated from the movements of the barycentre. In millimetres.
Delta y. Untreated
Time frame: Through study completion, an average of 4 days
Displacement on the y-axis within the ellipse calculated based on the movements of the barycentre. In millimetres.
Displacement on the major axis or y-axis. Untreated
Time frame: Through study completion, an average of 4 days
Displacement in millimetres of the y-axis.
Displacement on the minor axis or x-axis. Untreated
Time frame: Through study completion, an average of 4 days
Displacement in millimetres of the y-axis.
Maximum oscillation. Untreated
Time frame: Through study completion, an average of 4 days
Measurement of the length in millimetres of the maximum oscillations.
Minimum oscillation in millimetres. Untreated
Time frame: Through study completion, an average of 4 days
Measurement of the length in millimetres of the minimum oscillations
Length in millimetres of the centre of pressures with treatment
Time frame: Through study completion, an average of 4 days
Length of the centre of pressures described in millimetres.
Area of the ellipse with treatment
Time frame: Through study completion, an average of 4 days
Area of the ellipse in square millimeters.
Inclination of the ellipse in degrees with treatment
Time frame: Through study completion, an average of 4 days
Inclination of the ellipse generated by the centre of pressures in 30 seconds in degrees.
Length-area ratio with treatment
Time frame: Through study completion, an average of 4 days
Fraction of the length of the ellipse between the surface of the ellipse in millimetres.
Delta x with treatment
Time frame: Through study completion, an average of 4 days
Displacement on the x-axis within the ellipse calculated from the movements of the barycentre. In millimetres.
Delta y with treatment
Time frame: Through study completion, an average of 4 days
Displacement on the y-axis within the ellipse calculated based on the movements of the barycentre. In millimetres.
Displacement on the major axis or y-axis with treatment
Time frame: Through study completion, an average of 4 days
Displacement in millimetres of the y-axis.
Displacement on the minor axis or x-axis with treatment
Time frame: Through study completion, an average of 4 days
Displacement in millimetres of the y-axis.
Maximum oscillation with treatment
Time frame: Through study completion, an average of 4 days
Measurement of the length in millimetres of the maximum oscillations.
Minimum oscillation in millimetres with treatment
Time frame: Through study completion, an average of 4 days
Measurement of the length in millimetres of the minimum oscillations
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 7 Aug 2024.
- 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 Jiménez, PhD principal investigator
Universidad Complutense de Madrid
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 1 inclusion and 12 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 7 Aug 2024. 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?
Length in millimetres of the centre of pressures. Untreated (time frame: Through study completion, an average of 4 days). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.