- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06526715
Balance Effects of Morton´s Extension in Flat Foot
August 6, 2024 updated by: EVA MARIA MARTÍNEZ JIMENEZ, Mayuben Private Clinic
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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León, Spain, 24401
- Eva María Martínez-Jiménez
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Women and men aged 18 to 30 with flexible flat feet.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Morton.s extension treatment
Appliation of Morton´s extension treatment simulation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, an average of 4 days
|
|
Area of the ellipse. Untreated
Time Frame: Through study completion, an average of 4 days
|
Area of the ellipse in square millimeters.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
Maximum oscillation. Untreated
Time Frame: Through study completion, an average of 4 days
|
Measurement of the length in millimetres of the maximum oscillations.
|
Through study completion, an average of 4 days
|
|
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
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
Area of the ellipse with treatment
Time Frame: Through study completion, an average of 4 days
|
Area of the ellipse in square millimeters.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
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.
|
Through study completion, an average of 4 days
|
|
Maximum oscillation with treatment
Time Frame: Through study completion, an average of 4 days
|
Measurement of the length in millimetres of the maximum oscillations.
|
Through study completion, an average of 4 days
|
|
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
|
Through study completion, an average of 4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eva María Martínez Jiménez, PhD, Universidad Complutense de Madrid
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2024
Primary Completion (Actual)
August 5, 2024
Study Completion (Actual)
August 6, 2024
Study Registration Dates
First Submitted
July 24, 2024
First Submitted That Met QC Criteria
July 24, 2024
First Posted (Actual)
July 30, 2024
Study Record Updates
Last Update Posted (Actual)
August 7, 2024
Last Update Submitted That Met QC Criteria
August 6, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24/458-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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