The Effect of Insoles in Plantar Fasciitis

NCT ID: NCT06563492

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2026-07-21

Brief Summary

It aims to investigate the effect of two personalized insoles made of different materials designed to reduce pain in individuals with plantar fasciitis on muscle activation and gait parameters at 3-month follow-up.

Detailed Description

Plantar Fasciitis (PF) occurs after inflammation and thickening of the fascia, which originates from the medial tuberosity of the calcaneus and runs in the medial plantar part of the foot and has a thick fibrous band structure. It aims to investigate the effect of two personalized insoles made of different materials designed to reduce pain in individuals with plantar fasciitis on muscle activation and gait parameters at 3-month follow-up. The participants of the study will consist of male and female individuals between the ages of 18-65 who are diagnosed with plantar fasciitis by a specialist doctor, who apply to the Prosthetic Orthotics Center (POMER) with a personalized insoles prescription, and who volunteer to participate in the study.Participants will be provided with demographic information, foot function assessment, pedobarographic analysis, gait assessment, muscle activity assessment, and satisfaction assessment. The Foot Function Index (FFI) will be used to assess foot function in individuals with plantar fasciitis. Foot plantar pressure distribution analysis will be performed using the Tekscan software of the EsCoSCAN® pedobarographic assessment device. The plantar pressure analysis and physical evaluation of the individual will be performed and produced by Computer Aided Design and Computer Aided Manufacturing (CAD-CAM) method. Muscle activation data will be recorded with BIOSIGNALSPLUX Researcher Kit brand EMG device. Satisfaction Assessment-Orthotic Prosthesis Users Questionnaire (OPKA-M) will be used. Sensory evaluation will be evaluated with Semmes Weinstein monoflaments. All data will be evaluated by statistical analysis methods.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

EVA INSOLES

Group Type: ACTIVE_COMPARATOR

insole

Intervention Type: DEVICE

evaluation of individuals using different insoles

3D INSOLES

Group Type: ACTIVE_COMPARATOR

insole

Intervention Type: DEVICE

evaluation of individuals using different insoles

Interventions

insole

evaluation of individuals using different insoles

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Being between the ages of 18-65,
• Being diagnosed with plantar fasciitis,
• Being prescribed custom insoles,
• Having complaints for at least 3 months,
• Heel pain complaint is at the plantar medial calcaneal tubercle,
• Pain complaint is most evident in the first steps taken in the morning or in the steps after resting,
• Having a Roles and Maudsley score of 3 or 4 in the initial evaluation

Exclusion Criteria

• Having a body mass index greater than 30 kg/m2,
• Having any cardiopulmonary, dermatological, neurological or orthopedic problems other than plantar fasciitis,
• Having a history of foot or ankle surgery,
• Using an assistive device (walker, canadiens, etc.)
• Not using appropriate shoes,
• Having cognitive, mental and/or psychological problems
• Being pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Hande YAZICI

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Naile Hande YAZICI

Role: CONTACT

nhyazici@medipol.edu.tr

05315110940

Other Identifiers

HYAZICI

Identifier Type: -

Identifier Source: org_study_id