Investigation of the Effect of Intrinsic Foot Muscle Training on Plantar Pressure Distribution in Individuals With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Plantar Pressure Distribution
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 (Other)
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 (Other)
Group 3- Control Group
Group 3 will receive only general foot care instructions and education on appropriate footwear selection.
干预措施: Control (Other)
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)
研究者
Fatma Dilara Akar
Research Assistant
Saglik Bilimleri Universitesi