NCT04720651

Brief Summary

The purpose of the current work is to determine the prevalence of calf muscle tightness in asymptomatic flat foot subjects.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 19, 2021

Last Update Submit

January 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 14560897BACKGROUND
  • Tome 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.

    PMID: 17017268BACKGROUND
  • Van 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.

    PMID: 14560896BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sara Hassan, Bachelor

CONTACT

Enas Fawzy, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assisstant

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

February 1, 2021

Primary Completion

April 15, 2021

Study Completion

May 1, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01