Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear in Diabetic Patients and in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Reduction of Peak Pressure
研究概览
简要总结
Comparison and evaluation of pressure distribution, gait pattern, changes in the movement of the center of pressure, shock absorbing capabilities and comfort of wear using KyBoot shoes versus normal foot wear in diabetic and healthy subjects.
详细描述
Every 30 seconds a limb is lost somewhere in the world as a consequence of diabetes. These amputations are preceded by a foot ulcer in 84% of cases. Therefore, prevention of ulceration is of utmost importance.
Approximately one-half of all diabetic foot ulcers occur on the plantar foot surface and are mainly caused by elevated levels of mechanical pressure acting on the foot during ambulation in the presence of lost protective foot sensation from peripheral neuropathy.
Therefore, to reduce risk of ulceration, relief of mechanical pressure (also called offloading) is indicated.
Currently therapeutic footwear is provided by the Health maintenance organizations (HMO's) to diabetic patients that are at risk of developing foot ulcers.
Ideal footwear for a diabetic patient decreases weight-bearing pressure and shear forces applied to the skin of the foot by distributing the acting forces more evenly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •( for the group of diabetic patients)
- •Signing of informed consent
- •Diabetes mellitus Type 2
- •No major foot deformations necessitating fitting of personalized foot wear
- •Absence of diabetic foot ulcers and existence of sensory neuropathy confirmed by a physician
- •Intact cognitive function
- •Normal Gait
排除标准
- •An orthopedic or rheumatic disease that negatively influences range of motion, strength, gait or balance
- •Neurological diseases that influence proprioception , strength, balance, cognitive function / understanding, sight: Cerebro-vascular accident, Dementia, Spinal Cord injury, Head injury, Parkinson etc.
- •Injury or disease that can influence normal gait
- •Need for assistive devices : Crutches, cane, walker
- •Dialysis Treatment
结局指标
主要结局
Reduction of Peak Pressure
时间窗: 1 day
The pressure distribution will be measured by in-sole pressure sensors.
次要结局
- Comfort of wear(1 Day)
研究者
Dr. Itzhak Siev-Ner
Head of Orthopedic Rehabilitation department
Sheba Medical Center