Investigation of the Effect of Intrinsic Foot Muscle Training on Plantar Pressure Distribution in Individuals With Type 2 Diabetes Mellitus

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 Type 2 Diabetes Mellitus. 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 Type 2 Diabetes Mellitus.

H1: Foot intrinsic muscle training has an effect on plantar pressure in individuals with Type 2 Diabetes Mellitus.

In this study, individuals with Type 2 Diabetes Mellitus 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 3) and two experimental groups (Group 1 and Group 2). The sample size was determined using the G-power program. According to the results obtained, it was calculated that a total of 42 individuals should be included in the study, with 14 participants in each group, considering a statistical power level of 80% 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 3 - 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 1 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.

Inclusion criteria

• Agree to participate in the study voluntarily
• Be between the ages of 18-65
• Being diagnosed with type 2 diabetes
• IWGDF Risk Level 0-1 (no LOPS or PAD)

Exclusion criteria

• Refusing to participate in the study or wanting to leave the study
• Presence of severe deformity and/or orthopedic problem in the foot
• Presence of foot ulcer
• History of lower extremity surgery
• History of lower extremity amputation
• Having serious comorbidities (renal failure, severe retinopathy, cardiac problems, neurological problems)