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Clinical Trials/NCT06563492
NCT06563492
Not yet recruiting
Not Applicable

The Effect of Insoles on Muscle Activation and Gait Parameters in Plantar Fasciitis

Medipol University0 sites30 target enrollmentSeptember 16, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Plantar Fasciitis
Sponsor
Medipol University
Enrollment
30
Primary Endpoint
Electromyography
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2024
End Date
July 21, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Hande YAZICI

Lecturer

Medipol University

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

Outcomes

Primary Outcomes

Electromyography

Time Frame: Change from Baseline of treatment at 3 months

Muscle activation data will be recorded with BIOSIGNALSPLUX Researcher Kit brand EMG device. EMG is a frequently used method that evaluates muscle activation as a lens. In EMG measurements, signals are classified non-invasively using surface electrodes (20) The electrodes are planned according to the Gluteus Maximus, Gluteus Medius, Rectus Femoris, Biceps Femoris, Gastrocnemius Medialis and Lateralis, Soleus, Tibialis Anterior muscles.

Secondary Outcomes

  • Foot Function Index (FFI)(Change from Baseline of treatment at 3 months)
  • Satisfaction Evaluation(Change from Baseline of treatment at 3 months)
  • Sensory Evaluation(Change from Baseline of treatment at 3 months)
  • Pedobarographic Analysis(Change from Baseline of treatment at 3 months)

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