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The Effect of Insoles in Plantar Fasciitis

M

Medipol University

Status

Not yet enrolling

Conditions

Plantar Fasciitis

Treatments

Device: insole

Study type

Interventional

Funder types

Other

Identifiers

NCT06563492
HYAZICI

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

30 participants in 2 patient groups

EVA INSOLES
Active Comparator group
Treatment:
Device: insole
3D INSOLES
Active Comparator group
Treatment:
Device: insole

Trial contacts and locations

0

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Central trial contact

Naile Hande YAZICI

Data sourced from clinicaltrials.gov

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