The Effect of Insoles in Plantar Fasciitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: insole.
- Who it may be relevant to
- Registry conditions: Plantar Fasciitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Insoles on Muscle Activation and Gait Parameters in Plantar Fasciitis
Overview
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.
Interventions
- Device insole
evaluation of individuals using different insoles
Primary outcome measures
- Electromyography [Time frame: Change from Baseline of treatment at 3 months]
Secondary outcome measures (4)
- Pedobarographic Analysis [Time frame: Change from Baseline of treatment at 3 months]
- Foot Function Index (FFI) [Time frame: Change from Baseline of treatment at 3 months]
- Satisfaction Evaluation [Time frame: Change from Baseline of treatment at 3 months]
- Sensory Evaluation [Time frame: Change from Baseline of treatment at 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06563492 · HYAZICI