Flat FeetNCT04720651
Calf Muscle Tightness in Flat Foot Subjects
An observational study of Flat Feet, run by Cairo University.
Trial summary
The purpose of the current work is to determine the prevalence of calf muscle tightness in asymptomatic flat foot subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Flat Feet
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 May 2021
- 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 20 to 40 years
- All sexes
- Adult
Study population: Subjects with flexible flat foot aged between 20 and 40 years old . They should have navicular drop more than 10 mm and their body mass index is between 18.5 kg/m2 to 29.9 kg/m2.
Who may be able to join
- Subjects should have flexible flat foot.
- Age between 20 and 40 years.
- Navicular drop of more than 10 mm.
- Body Mass Index from 18.5 kg/m2 to 29.9 kg/m2.
- Subjects will sign the written consent form after the aim and methods of the study are explained clearly.
Who cannot join
- Subjects with history of foot and ankle surgery, trauma, fracture or dislocation.
- Subjects with congenital deformities in the ankle and foot.
- Subjects with systemic or neurologic diseases that could affect lower extremity biomechanics.
Trial locations and contacts
No sites are listed yet.
Enas Fawzy, Professor contact
About this study
Official title: Prevalence of Calf Muscle Tightness in Asymptomatic Flat Foot Subjects
The purpose of the current work is to determine the prevalence of calf muscle tightness in asymptomatic flat foot subjects.
Read the detailed description
Pes planus (Flat foot) deformity is a common chronic foot and ankle condition characterized by flattening of the medial longitudinal arch (MLA), rearfoot valgus and abduction of the midfoot on the hind foot.
A flexible pes planus is caused by tibialis posterior dysfunction, ligament loosening, Achilles tendon shortening, and weakness of the intrinsic foot muscles. These deformations cause plantar flexion and adduction of the talus bone and valgus of the calcaneus bone.
Up to our knowledge:
- No previous studies investigated whether all flat foot is usually associated with gastrocnemius and soleus muscle tightness or it is a random association.
- And whether tightness of gastrocnemius and soleus is highly found in all cases of flat foot.
Consequently this study is conducted.
- Conditions
- Flat Feet
- Medical subject headings
- Flatfoot
What is being measured
The primary outcome is the main question the study is designed to answer.
tightness of the calf muscle
measuring of ankle dorsi flexion range of motion with knee extension and with knee flexion in flat foot subjects with navicular drop more than 1 cm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Flat FeetStudies 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
- Prospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Hassan Kamel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720651
- Sponsor's protocol ID
- Calf muscle in flat foot
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meehan RE, Brage M. Adult acquired flat foot deformity: clinical and radiographic examination. Foot Ankle Clin. 2003 Sep;8(3):431-52. doi: 10.1016/s1083-7515(03)00019-6.
PubMed 14560897Tome J, Nawoczenski DA, Flemister A, Houck J. Comparison of foot kinematics between subjects with posterior tibialis tendon dysfunction and healthy controls. J Orthop Sports Phys Ther. 2006 Sep;36(9):635-44. doi: 10.2519/jospt.2006.2293.
PubMed 17017268Van Boerum DH, Sangeorzan BJ. Biomechanics and pathophysiology of flat foot. Foot Ankle Clin. 2003 Sep;8(3):419-30. doi: 10.1016/s1083-7515(03)00084-6.
PubMed 14560896
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Calf Muscle Tightness in Asymptomatic Flat Foot Subjects
- ClinicalTrials.gov ID
- NCT04720651
- Acronym / sponsor ID
- Calf muscle in flat foot
- Conditions
- Flat Feet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 22 Jan 2021 (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 the current work is to determine the prevalence of calf muscle tightness in asymptomatic flat foot subjects.
Detailed description
Pes planus (Flat foot) deformity is a common chronic foot and ankle condition characterized by flattening of the medial longitudinal arch (MLA), rearfoot valgus and abduction of the midfoot on the hind foot.
A flexible pes planus is caused by tibialis posterior dysfunction, ligament loosening, Achilles tendon shortening, and weakness of the intrinsic foot muscles. These deformations cause plantar flexion and adduction of the talus bone and valgus of the calcaneus bone.
Up to our knowledge:
- No previous studies investigated whether all flat foot is usually associated with gastrocnemius and soleus muscle tightness or it is a random association.
- And whether tightness of gastrocnemius and soleus is highly found in all cases of flat foot.
Consequently this study is conducted.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Subjects with flexible flat foot aged between 20 and 40 years old . They should have navicular drop more than 10 mm and their body mass index is between 18.5 kg/m2 to 29.9 kg/m2.
Key inclusion criteria (5 listed)
- Subjects should have flexible flat foot.
- Age between 20 and 40 years.
- Navicular drop of more than 10 mm.
- Body Mass Index from 18.5 kg/m2 to 29.9 kg/m2.
- Subjects will sign the written consent form after the aim and methods of the study are explained clearly.
Key exclusion criteria (3 listed)
- Subjects with history of foot and ankle surgery, trauma, fracture or dislocation.
- Subjects with congenital deformities in the ankle and foot.
- Subjects with systemic or neurologic diseases that could affect lower extremity biomechanics.
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
tightness of the calf muscle
Time frame: 3 months
measuring of ankle dorsi flexion range of motion with knee extension and with knee flexion in flat foot subjects with navicular drop more than 1 cm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Background: PubMed 14560897Meehan RE, Brage M. Adult acquired flat foot deformity: clinical and radiographic examination. Foot Ankle Clin. 2003 Sep;8(3):431-52. doi: 10.1016/s1083-7515(03)00019-6.
- Background: PubMed 17017268Tome J, Nawoczenski DA, Flemister A, Houck J. Comparison of foot kinematics between subjects with posterior tibialis tendon dysfunction and healthy controls. J Orthop Sports Phys Ther. 2006 Sep;36(9):635-44. doi: 10.2519/jospt.2006.2293.
- Background: PubMed 14560896Van Boerum DH, Sangeorzan BJ. Biomechanics and pathophysiology of flat foot. Foot Ankle Clin. 2003 Sep;8(3):419-30. doi: 10.1016/s1083-7515(03)00084-6.
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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.
Enas Fawzy, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Flat Feet, run by Cairo University.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Hassan, Bachelor (+20-01068999632, Sara.Hassan@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tightness of the calf muscle (time frame: 3 months). 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 NCT04720651, which also lists 3 linked publications.
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 22 Jan 2021.