Effects of Foot Muscle Strengthening in Daily Activity, Biomechanics and Functionality of Foot and Ankle in Diabetic Polyneuropathy Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Self Selected Gait Speed
研究概览
简要总结
The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.
详细描述
A randomized controlled trial will be performed with 77 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no exercises) or an intervention group which will receive 12-week physical therapy exercises, twice a week, under the supervision of a physiotherapist, and twice a week being remotely supervised by a software at home. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.
The subjects will be evaluated in 5 different moments (Baseline, 6 weeks, 12 weeks, 24 weeks and 1 year follow-up)
The hypothesis of this study is that the intervention group will increase daily activity levels, increase self-selected and rapid walking speed, reduce the incidence of plantar ulcers, increase foot health and functionality, improve symptoms, increase tactile and vibration sensitivity, increased passive range of motion, improved quality of life, increased isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group after 12 weeks of intervention and follow-up year.
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)
入排标准
- 年龄范围
- 18 Years 至 75 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 polyneuropathy confirmed with the fuzzy software
- •Ability to walk independently in the laboratory
- •Accessibility to electronic devices
- •Loss of at least 4 degrees of ankle range of motion
- •Loss of at least 1 degree of force in the clinical scale of the plantar interosseous or lumbrical muscles
排除标准
- •Ulceration not healed for at least 6 months
- •Hallux amputation or total amputation of the foot
- •Receiving any physiotherapy intervention or offloading devices
- •Neurological or orthopedic impairments
- •Major vascular complications
- •Severe retinopathy
结局指标
主要结局
Self Selected Gait Speed
时间窗: 12 weeks
self selected gait speed shod walking velocity in a walkway
Fast Gait Speed
时间窗: 12 weeks
Fast gait speed shod walking velocity in a walkway
Daily Physical Activity
时间窗: 12 weeks
Calculate the number of steps per week
次要结局
- Foot and Ankle Kinematics During Gait(baseline, 12 weeks)
- Plantar Ulcers(12 months)
- Tactile Sensitivity(12 weeks)
- Range of Motion(12 weeks)
- Risk Classification of Plantar Ulceration(12 weeks)
- Foot Health and Functionality(12 weeks)
- Foot Strength(12 weeks)
- Ankle and Knee Joint Moments and Power During Gait(baseline, 12 weeks)
- Vibration Sensitivity(12 weeks)
- Neuropathy Symptoms(12 weeks)
- EQ-5D Score(12 weeks)
研究者
Isabel de Camargo Neves Sacco
Associate Professor
University of Sao Paulo General Hospital