Flexible FlatfootNCT06879756
Relationship Between Flexible Flat Foot and Lumbar Proprioception
An observational study of Flexible Flatfoot and Lumbar Spine Injury, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study was to determine the relationship between flexible flatfoot and lumbar proprioception. Read more about this study
- Who is it for?
- Ages 17 to 35 years
- Conditions the study is for
- Flexible Flatfoot, Lumbar Spine Injury, Proprioceptive Disorders
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Oct 2024to 22 Jan 2025
- Phase
- Observational
- 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 17 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- ankle fracture
- lumbar fracture
- spondylosis
- lumbar disc bulge
- spondylolisthesis
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, Cairo university
Cairo
About this study
The purpose of this study was to determine the relationship between flexible flatfoot and lumbar proprioception.
Read the 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.
- Medical subject headings
- Flatfoot, Spinal Injuries, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| flexible flat feet | 28 patients suffering from flexible flatfoot were included in this group | |
| normal subjects | 27 normal subjects were included in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the foot posture using navicular drop test
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).
Measured: at baseline
Secondary outcomes (1)
assessment of change of lumbar proprioception using Biodex system isokinetic dynamometer
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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start9 Oct 2024
- Primary completion15 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible FlatfootStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Anwar Mohamed Elmeligy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879756
- Sponsor's protocol ID
- Hoda-005289
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 17 Mar 2025
- 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 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Flexible Flat Foot and Lumbar Proprioception
- ClinicalTrials.gov ID
- NCT06879756
- Acronym / sponsor ID
- Hoda-005289
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 17 Mar 2025 (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 purpose of this study was to determine the relationship between flexible flatfoot and lumbar proprioception.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flexible flat feet | – | –28 patients suffering from flexible flatfoot were included in this group |
| normal subjects | – | –27 normal subjects were included in this group |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Repeated lower extremity injuries, such as fractures or deformities.
- History of surgery to the lower extremity.
- history of back surgery
- rheumatologic disorders
- spine infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assessment of the foot posture using navicular drop test
Time frame: at baseline
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).
1 secondary outcome
assessment of change of lumbar proprioception using Biodex system isokinetic dynamometer
Time frame: at baseline
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 17 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Flexible Flatfoot
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Active, not recruitingObservational study
Clinical and Functional Outcomes After Subtalar Arthroereisis in Pediatric Flexible Flatfoot
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Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot
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Recruiting
Effects of Hip-Based Versus Knee-Based Exercises on Medial Longitudinal Arch, Dynamic Balance, and Muscle Strength in Flexible Flatfoot
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Not yet recruiting
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
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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?
An observational study of Flexible Flatfoot and Lumbar Spine Injury, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 11 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 17 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 Egypt. 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?
assessment of the foot posture using navicular drop test (time frame: at baseline). 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 17 Mar 2025.