Investigation of the Effect of Intrinsic Foot Muscle Training on Plantar Pressure Distribution in Individuals With Type 2 Diabetes Mellitus
概览
- 阶段
- 不适用
- 干预措施
- Aerobic Exercise
- 疾病 / 适应症
- 未指定
- 发起方
- Saglik Bilimleri Universitesi
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Plantar Pressure Distribution
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
Fatma Dilara Akar
Research Assistant
Saglik Bilimleri Universitesi
入排标准
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Group 1- Aerobic Exercise
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.
干预措施: Aerobic Exercise
Group 2- Intrinsic Muscle Training
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.
干预措施: Intrinsic Muscle Training
Group 3- Control Group
Group 3 will receive only general foot care instructions and education on appropriate footwear selection.
干预措施: Control
结局指标
主要结局
Plantar Pressure Distribution
时间窗: 3 months
Plantar pressure distribution analysis will be performed statically and dynamically with the Baropodometric Platforms Freemed™, 120 cm (Sensor Medica, Italia) pedobarography platform and software. In order to obtain the static plantar pressure distribution parameters of the people included in the study, on the surface with a pressure gauge sensor; As soon as the pressure falling on one foot reaches the value to be determined, it will be analyzed during standing static stance.
次要结局
- Foot Posture(3 months)