Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-II) Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks
研究概览
简要总结
The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.
详细描述
A randomized controlled trial will be performed with 48 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform exercises at home, three times a week, through the booklet for 8-weeks.
The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 8weeks, for all outcomes; and 16 weeks, for follow-up reasons for all outcomes.
The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) tactile and vibration sensititivity (10-g monofilament and tuning fork), (4) foot-ankle kinematics and ankle kinetics during gait (infrared cameras and inverse dynamics, respectively), (5) foot isometric strength (by a pressure plate measurement), (6) functional balance reach test, (7) foot health and functionality by the Foot Health Status Questionnaire, (8) plantar pressure distribution during gait.
The hypothesis of this study is that the intervention will increase the perception of the tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, increase the functional balance score, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, promote a more physiological foot rollover with a redistribution of plantar pressure during gait, as well as increase foot-ankle mobility after 08-weeks of intervention. There will be also beneficial biomechanical changes during gait, such as: (1) increase in the ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in the ankle flexor moment and ankle eccentric power in the load phase.
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
Investigator (allocation, statistics, data processing) and assessor will be blid to the subjects allocation. To evaluate whether or not there was a failure in blinding of the outcome assessor, investigators and other assessors, they will be asked to guess which group the patients belonged to at the end of 8-weeks of treatment. Then the assessors will classify the certainty of their opinions according to a scale (1 = not sure, 5 = completely sure). To ensure that the assessor is not induced to correctly guess the participants' allocation, the patient will be instructed to not disclose any behavior details during the previous 8-weeks.
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
- 否
入选标准
- •Diabetes mellitus type 1 or 2;
- •Moderate or severe neuropathy confirmed with the fuzzy software;
- •Ability to walk independently in the laboratory
排除标准
- •Hallux amputation or total amputation of the foot;
- •History of surgical procedure in the knee, ankle or hip;
- •History of arthroplasty and / or lower limb orthosis or indication of lower limb arthroplasty throughout the intervention period;
- •Neurological and / or rheumatologic diseases diagnosed;
- •Inability to provide consistent information;
- •Perform physiotherapy intervention throughout the intervention period;
- •Receiving any physiotherapy intervention or offloading devices;
- •Major vascular complications;
- •Severe retinopathy;
- •Ulceration not healed for at least 6 months and / or active ulcer;
- •Score between 12-21 (Probable Depression) from the Hospital Anxiety and Depression Scale (HADS).
结局指标
主要结局
Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks
时间窗: 8-weeks
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy).
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 8-weeks
时间窗: 8-weeks
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture (LaBIMPH) available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up)
时间窗: 16-weeks (Follow-up)
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy).
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 16-weeks (Follow-up)
时间窗: 16-weeks (Follow-up)
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture (LaBIMPH) available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
次要结局
- Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks(8-weeks)
- Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks(8-weeks)
- Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks(8-weeks)
- Change From Baseline Tactile Sensitivity at 8-weeks(8-weeks)
- Change From Baseline Vibration Sensitivity at 8-weeks(8-weeks)
- Change From Baseline Foot Health and Functionality at 8-weeks(8-weeks)
- Change From Baseline Foot Isometric Strength at 8-weeks(8-weeks)
- Change From Baseline Functional Balance at 8-weeks(8-weeks)
- Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up)(16-weeks (Follow-up))
- Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up)(16-weeks (Follow-up))
- Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up)(16-weeks (Follow-up))
- Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up)(16-weeks (Follow-up))
- Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up)(16-weeks (follow-up))
- Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up)(16-weeks (Follow-up))
- Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up)(16-weeks (Follow-up))
- Change From Baseline Functional Balance at 16-weeks (Follow-up)(16-weeks (Follow-up))
研究者
Isabel de Camargo Neves Sacco
Associate Professor
University of Sao Paulo General Hospital