The Effect of Insoles in Plantar Fasciitis
NCT Number: NCT06563492
Acronym: Insoles
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Plantar Fasciitis
Interventions: DEVICE: insole
Sponsor: Medipol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-09-16
Completion Date: 2026-07-21

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.

Primary Outcome Measures: Electromyography, 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., Change from Baseline of treatment at 3 months
Secondary Outcome Measures: Pedobarographic Analysis, Foot plantar pressure distribution analysis will be performed using the Tekscan software of the EsCoSCAN® pedobarographic evaluation device. In the static analysis; fore-hindfoot loading (kg), total loading (kg), fore-hindfoot weight ratio (%), fore-hindfoot plantar contact surface (cm2), total plantar contact surface (cm2), maximum pressure (kg/cm2), average pressure (kg/cm2), foot center (CoF), foot angle (°) values are obtained. Fore-hindfoot relationship is also evaluated. In dynamic analysis; Fore-hindfoot loading (kg), total loading (kg), foot plantar contact surface (cm2), average pressure (kg/cm2), maximum pressure (kg/cm2), acceleration (cm/s), step length (cm), cadence (step/min) and step width data of the individual are recorded. Fore-hindfoot relationship is also evaluated under dynamic conditions., Change from Baseline of treatment at 3 months|Foot Function Index (FFI), The Foot Function Index (FFI) will be used to assess foot function in individuals with plantar fasciitis. The foot function index is a widely used form that can be completed by the individual and developed to measure the effects of foot pathologies on pain, disability and activity limitation. Yalıman et al. translated and adapted the Foot Function Index to Turkish for patients with plantar fasciitis. It consists of 23 items with 3 subgroups. The pain subscale, which includes 9 items, measures the level of foot pain in various situations, while the disability subscale, which includes 9 items, determines the degree of difficulty in performing various functional activities due to foot problems. The activity limitation subscale, which includes 5 items, evaluates activity limitations due to foot problems., Change from Baseline of treatment at 3 months|Satisfaction Evaluation, Orthosis Prosthesis Users Survey (OPKA-M) was developed in 2003. It is used to make quality assessment in the field of orthosis and prosthesis, to maintain awareness of development in activities, to evaluate changes in functional status and quality of life of patients, to evaluate satisfaction with prosthesis orthosis and services. OPKA-M survey is a satisfaction survey developed for upper and lower extremity prosthesis and orthosis users. It consists of 21 questions in total. It is a survey that evaluates satisfaction with the orthosis used and the service received., Change from Baseline of treatment at 3 months|Sensory Evaluation, Loss of pressure sensation will be assessed with "Semmes Weinstein" monofilaments. If there is loss of sensation in the assessment made with this filament that applies 10 g pressure to the foot, the patient's foot is at risk and the protective sensation has been lost. The 5.07 nylon monofilament used in the test is manufactured to bend when 10 g force is applied. This pressure is applied to specific points located on the plantar and dorsal sides of the foot., Change from Baseline of treatment at 3 months