Effectiveness of Proprioceptive Training on Plantar Pressure, Postural Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Balance
研究概览
简要总结
Introduction: Diabetes mellitus (DM) can be considered as one of the most important chronic diseases in the public health system, presenting a high cost for health services. Along with the increase in diagnosed cases of DM, there is a simultaneous increase in DM-related manifestations, such as peripheral diabetic neuropathy, diabetic foot ulcers and amputations. Decreased plantar sensitivity caused by microvascular complications, reduced sensation of vibration and loss of pressure sensitivity may be associated with recurrent falls due to reduced proprioceptive feedback. Although much is known about the beneficial results of physical exercise on glucose metabolism and insulin action, there are still few studies that evaluate the effects of different types of physical exercise, especially proprioceptive training, on plantar pressure, balance and posture of individuals.
Objective: The present study aims to evaluate the efficacy of proprioceptive training on plantar pressure, postural balance and posture in adults with Type 2 Diabetes Mellitus.
Methods: This study is a randomized, double blind, controlled clinical trial (evaluator and statistician) with individuals of both sexes, with type 2 diabetes mellitus diagnosed for at least 3 years, over 45 years of age, that can walk without assistance or supervision of others. Two groups will be formed, the Control Group (CG) and the Trained Group (TG), and the ideal "n" will be calculated in a pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Double (Investigator, Outcomes Assessor) The one who assess the patients in the beginning and in the final moment (investigator) not know in what group the patient is. As the investigator that will do the statistic (outcome assessor).
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals with type 2 diabetes mellitus, diagnosed for at least 3 years
- •both genders
- •aged 45 years or over
- •able to wander without assistance or supervision from others
- •absence of macroangiopathy
- •no history of neurological, muscular or rheumatic diseases for the etiology of diabetes
- •agree to participate in the study, signing the Free and Informed Consent Term (TCLE) pursuant to Resolution 466/12 of the National Health Council
排除标准
- •presence of uncontrolled hypertension (systolic ≥ 200 mmHg and / or diastolic ≤100 mmHg);
- •presence of a rheumatic condition that makes it impossible to perform the movements performed in the evaluation and in the therapeutic intervention;
- •lack of more than 15% to the proprioceptive training program;
- •individuals who perform some physical activity
- •dependence on alcohol and illicit drugs
研究组 & 干预措施
Proprioceptive Training
The group participates in proprioceptive training that promotes sensory integration.
干预措施: Proprioceptive Training (Other)
Control Group
The group continues in their daily lives with phone monitoring.
干预措施: Control Group (Other)
结局指标
主要结局
Balance
时间窗: 5 minutes
Modular baropodometric platform MPS (M.P.S. Loran, KINETEC), where distance of C.O.P are provide in (mm) and average speed in (mm / sec), provided by BIOMECH STUDIO software.
Posture
时间窗: 1 hour
Optoelectronic system (SMART DX100, produced by BTS Bioengineering, Milan, Italy)
Gait
时间窗: 10 minutes
The Time Up And Go Test (TUG) was performed using the Wiva® Science sensor KINETEC® type inertial sensor
Plantar Pressure
时间窗: 5 minutes
Modular baropodometric platform MPS (M.P.S. Loran, KINETEC), where plantar pressure variables are provided in (Kgf / cm²) and plantar surface area (cm²) provided by BIOMECH STUDIO software.
次要结局
- Plantar Sensitivity(10 minutes)
研究者
Kelly Antunes e Silva Oliveira
Bachelor
Universidade Federal de Pernambuco