Investigation of the Effect of Foot Intrinsic Muscle Training in Individuals With Diabetic Foot Syndrome
Condition: Diabetic Foot
MeSH terms: Diabetic Foot
Study type: Interventional

Summary: 
      The goal of this experimental randomized controlled study is to evaluate the effectiveness of
      the exercise program to be applied to prevent foot wounds, which is one of the leading foot
      problems that develop as a result of diabetes, based on foot posture and plantar pressure
      distribution.

      Participants who meet the inclusion criteria and are between the ages of 18-65 will be
      randomly assigned to one of the two experimental groups or the control group.Participants
      will be assessed through surveys to evaluate their physical activity level, foot health and
      functionality, and sensory status of the feet. Measurements related to foot position and
      posture will be taken. The use of a pedobarography device will allow for the examination of
      plantar pressure distribution. Following these assessments, participants will receive general
      foot care instructions and information on appropriate footwear, along with the designated
      exercise program.

      During routine check-ups and treatment procedures related to diabetes, blood glucose levels
      and HbA1c values taken from participants will be analyzed by the physician before and after
      the program to make comparisons. The study is planned to last for 12 weeks, and evaluations
      will be conducted before and after the program.
    

Detailed description: 
      According to the literature, evaluations for preventing and treating diabetic foot ulcers
      commonly include plantar pressure measurements, and it is emphasized that methods involving
      plantar pressure technologies should be added to traditional evaluations to be more
      successful in preventing diabetic foot ulcers, even in high-risk individuals.

      Based on the findings from previous research, it is believed that the reduced foot intrinsic
      muscle strength, which has not been extensively examined in its relationship with other
      factors, needs to be systematically investigated for its effects on foot related measurements
      and plantar pressure. Furthermore, there seems to be insufficient information regarding
      exercise interventions focusing on foot intrinsic muscle training for preventing ulcer
      development in diabetic foot. Therefore, the aim of the study is to examine the effects of
      foot intrinsic muscle training on foot posture and plantar pressure distribution in
      individuals with diabetic foot syndrome. By elucidating these factors, it is hoped that the
      exercise protocol focusing on foot intrinsic muscle training, implemented to prevent ulcer
      formation, will contribute to the literature and reduce the burdens associated with the
      disease.

      Hypotheses of the study:

      H0: Foot intrinsic muscle training has no effect on plantar pressure in individuals with
      diabetic foot syndrome.

      H1: Foot intrinsic muscle training has an effect on plantar pressure in individuals with
      diabetic foot syndrome.

      H2: Foot intrinsic muscle training has no effect on foot posture in individuals with diabetic
      foot syndrome.

      H3: Foot intrinsic muscle training has an effect on foot posture in individuals with diabetic
      foot syndrome.

      In this study, individuals with diabetic foot syndrome between the ages of 18-65 will be
      included. The study is designed as a randomized controlled trial, and the participants will
      be divided into three groups: one control group (Group 1) and two experimental groups (Group
      2 and Group 3). The sample size was determined using the G-power program. According to the
      results obtained, it was calculated that a total of 30 individuals should be included in the
      study, with 10 participants in each group, considering a statistical power level of 82% and a
      significance level of 5%.

      As part of the research, investigators will gain insights into participants' foot health
      through questionnaire questions, complete observational analyses of foot and foot-related
      measurements, evaluate participants' plantar pressure distribution using pedobarographic
      analysis, and implement exercise protocols focusing on foot intrinsic muscle training.

      The study was designed with evaluation and treatment protocols. Demographic information and
      physical activity levels of the participants to be included in the study will be recorded.
      The measurements related to the foot will include evaluation of foot posture, goniometric
      measurements, assessment of tactile sensation, plantar pressure distribution analysis, and
      questionnaire evaluations. In addition to all these assessments, participants' blood values
      will be examined by the doctor before and after treatment.

      The treatment protocols consist of general foot care instructions and information about
      appropriate footwear selection, along with exercise protocols. Group 1 - Control Group
      participants will receive only general foot care instructions and education on appropriate
      footwear selection. Group 2 participants will receive general foot care instructions and
      education on appropriate footwear selection, along with an exercise protocol focusing on foot
      intrinsic muscle training. Group 3 participants will receive general foot care instructions
      and education on appropriate footwear selection, foot intrinsic muscle training, and in
      addition, an aerobic exercise protocol. The treatment protocols will be implemented for 12
      weeks, and pre- and post-treatment evaluations will be repeated to compare the results.
    

Intervention name(s): Control; Intrinsic Muscle Training; Aerobic Exercise
Intervention type(s): Other; Other; Other
Intervention description(s): No intervention will be applied to the control group, and information will be given on general foot care instructions and the use of appropriate shoes.; In addition to general foot care instructions and briefings on the use of appropriate shoes, intrinsic muscle training including alternating toe movement, toes picking up sheets, opening and closing the toes, pinching the toe separators, toe transitions and short foot exercises will be implemented.
Additionaly, warm-up exercises, ankle exercises and functional exercises will be included in the program.; In addition to general foot care instructions and information on the use of appropriate shoes, warm-up exercises, ankle exercises, functional exercises and intrinsic muscle training, the participants will be given a walking program for aerobic exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diabetic foot; exercise; plantar pressure; intrinsic mucle training