NCT05579054

Brief Summary

Individuals with foot-ankle problems (plantar fasciitis, metarsalgia, pes planus, pes planovalgus/varus) will be included in the study. Permission was obtained from the research group that developed the scale to use the Original Foot Posture Index-6 (FPI-6). Cross-cultural adaptation of the FPI-6 will be made in line with the guidelines published by Ruberto and Beaton. First of all, the FPI-6 will be translated into Turkish by two translators whose native language is Turkish and who can speak English at an advanced level. Translations will be compared and discussed, and a Turkish version will be obtained with the equivalents that best represent each item in the texts. Secondly, this retranslated text will be independently translated back into English by two native English translators. In the third stage, two texts written in English will be synthesized by the authors, thus reaching a consensus on a single translation. Finally, the inconsistent parts of the text will be checked by a multidisciplinary team consisting of two native English-speaking translators, members of the English language and literature department, authors who developed the scale, and physiotherapists. Two independent physiotherapists will evaluate the participants' foot posture indexes by FPI-6 for inter-rater reliability. In addition, patients' quality of life, foot functions, hindfoot profiles will be evaluated. For the calculation of validity between measurements, rater-1 will apply the FPI-6 again to the same participants after 15 days for intra-rater reliability. Patients' functional independence, activities of daily living, and quality of life will also be evaluated for criterion validity. American Orthopedic Foot and Ankle Society-AOFAS, SF-36 and Foot Function Index questionnaires will be applied for the validity of FPI-6.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

October 11, 2022

Last Update Submit

December 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Foot Posture Index (FPI-6)

    PI-6 is a valid and reliable assessment tool for pediatrics in which 6 items are scored separately for the right and left feet while the patient was in an upright position in a relaxed posture with their body-weight evenly distributed on the both feet. Each item is scored as -2, -1, 0, 1, 2 and the assessment categorized as follows: 0 to +5 normal; +6 to +9 pronated; 10+ higly pronated; -1 to -4 supianted; and -5 to -12 higly supinated.

    10 minutes

Secondary Outcomes (3)

  • Foot Function Index

    10 minutes

  • American Orthopedic Foot and Ankle Society-AOFAS

    10 minutes

  • SF-36

    15 minutes

Interventions

FPI-6 is a valid and reliable assessment tool for pediatrics in which 6 items are scored separately for the right and left feet while the patient was in an upright position in a relaxed posture with their body-weight evenly distributed on the both feet. Each item is scored as -2, -1, 0, 1, 2 and the assessment categorized as follows: 0 to +5 normal; +6 to +9 pronated; 10+ higly pronated; -1 to -4 supianted; and -5 to -12 higly supinated.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study group will consist of individuals between the ages of 18-65 with foot problems.

You may qualify if:

  • being between the ages of 18-65,
  • having foot-ankle problems (plantar fasciitis, metatarsalgia, pes planus, pes planovalgus/varus, hallux valgus, pes cavus, pain)

You may not qualify if:

  • Having undergone any lower extremity surgery in the last two years,
  • patients with congenital foot deformity and neurological problems,
  • Individuals with lower or upper extremity pathology or a cognitive problem that may prevent or limit the application of the test protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Güllü Aydın Yağcıoğlu

Isparta, 32100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Foot DeformitiesFlatfootHallux ValgusMetatarsalgiaClubfoot

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesTalipesFoot Deformities, AcquiredFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFoot DiseasesJoint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asisstant

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 13, 2022

Study Start

September 20, 2022

Primary Completion

November 20, 2022

Study Completion

November 29, 2022

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations