- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06879756
Relationship Between Flexible Flat Foot and Lumbar Proprioception
March 11, 2025 updated by: Hoda Anwar Mohamed Elmeligy, Cairo University
The purpose of this study was to determine the relationship between flexible flatfoot and lumbar proprioception.
Study Overview
Status
Completed
Detailed Description
The human foot plays a crucial role in maintaining balance during various activities, and poor foot alignment, such as excessive subtalar joint pronation, can lead to leg, knee, and back pain.
Proprioception is essential for active joint stability, as it indirectly modulates and provides motor response, helping the neuromuscular system maintain balance.
Lumbar proprioception deficits can decrease the ability to assume a neutral spinal posture and coordinate muscle contraction, affecting spinal segmental function, dynamic joint stability, and good motor control.
This study investigates the association between flatfoot and lumbar proprioception.
Study Type
Observational
Enrollment (Actual)
57
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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Cairo, Egypt
- out-patient clinic, faculty of physical therapy, Cairo university
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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
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
• Subjects with flexible flat foot posture according to the Navicular Drop Test by Brody method: a normal foot (between five and nine mm of navicular drop), apronated foot (more than 10 mm of navicular drop).
Description
Inclusion Criteria:
- 60 subjects of both sexes (females and males) were selected and assigned into two groups
- Patient's age range was between 17 to 30 years old.
- Subjects with flexible flat foot posture according to the Navicular Drop Test by Brody method: a normal foot (between five and nine mm of navicular drop), pronated foot (more than 10 mm of navicular drop).
- Patients will be willing and able to participate in assessment without cognitive impairments that would limit their participation
Exclusion Criteria:
The potential participation was excluded when they had one of the following criteria:
- Repeated lower extremity injuries, such as fractures or deformities.
- History of surgery to the lower extremity.
- history of back surgery
- rheumatologic disorders
- spine infections
- ankle fracture
- lumbar fracture
- spondylosis
- lumbar disc bulge
- spondylolisthesis
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
Cohorts and Interventions
Group / Cohort |
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flexible flat feet
28 patients suffering from flexible flatfoot were included in this group
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normal subjects
27 normal subjects were included in this group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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assessment of the foot posture using navicular drop test
Time Frame: at baseline
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The study evaluates foot posture in a weight-bearing position by placing the thumb and index fingers on the medial and lateral aspects of the talar dome.
The subject is then asked to invert and evert the hind-foot and ankle until equal depressions are felt.
The distance between the navicular tubercle and the floor is measured.
The navicular-drop score is recorded, and the subject is classified into a pronated foot (more than 10 mm of navicular drop) and a normal foot (between five and nine mm of navicular drop).
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at baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of change of lumbar proprioception using Biodex system isokinetic dynamometer
Time Frame: at baseline
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The Biodex System 3 Pro isokinetic device is used to measure lumbar proprioception.
The device offers isokinetic, eccentric, isometric, and passive modes for all body joints and is equipped with various attachments and isolation straps.
The system is equipped with a computer unit and a special testing unit for lumbar area testing.
Subjects are instructed to sit on the lumbar attachment unit with their hips and knees flexed at 90 degrees, strapped around their thigh, pelvis, and trunk, and fold their arms above their chest.
The selected test is active repositioning error/speed 30o/S, with a target position of 30° lumbar flexion.
The device is locked in 0° position during trials, and the isokinetic device software calculates the mean of the three real testing results.
The isokinetic machine prints the results, providing each trial's error value and the average error of the three trials.
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at baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 9, 2024
Primary Completion (Actual)
January 15, 2025
Study Completion (Actual)
January 22, 2025
Study Registration Dates
First Submitted
March 10, 2025
First Submitted That Met QC Criteria
March 11, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 11, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Talipes
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Wounds and Injuries
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Sensation Disorders
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Back Injuries
- Somatosensory Disorders
- Flatfoot
- Spinal Injuries
Other Study ID Numbers
- Hoda-005289
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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