Somatosensory Restoration and Postural Control Improvement in People With Diabetic Peripheral Neuropathy Applying Sensorimotor Training: a Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Cumulative Somatosensory Impairment Index
研究概览
简要总结
Adults with diabetic peripheral neuropathy tend to fall more frequently than healthy population as a consequence of multiple sensorimotor and cognitive damages. In this protocol study, a randomized controlled trial is proposed using a sensorimotor intervention based on Feldenkrais method to improve somatosensory aspects and, therefore, postural control of participants.
详细描述
Among all the systems suffering damage due to hyperglucemia toxicity in diabetes, somatosensory system, composed by proprioception and skin sensory receptors has a key role since it is in charge of the faster body reaction when a postural control response is needed. Despite of it, few studies have focused on this issue. This randomized controlled trial proposed a safe and easy training adapted to adults and old people with diabetic peripheral neuropathy. Pressure, touch, proprioception and graphesthesia sensibility were measured, as well as functionality in daily basis, quality of life and fear of falling.
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
measurements and statistical analysis were made without knowing who participated in control or experimental group
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having peripheral neuropathy and history of falls or risk factors for it. Current ulcer -
排除标准
- •amputation and cognitive or mental issues
结局指标
主要结局
Cumulative Somatosensory Impairment Index
时间窗: 2 years
It measures proprioception, pressure and vibration sensitivity and graphesthesia to sum up somatosensory function in lower legs. Iti is ranging from 0 to 8 being 8 the worst result
次要结局
- Four Square Step test(2 years)
- Up and Go test(2 years)
- SF-36 Health Survey questionnaire , 1.4 version.(2 years)
- Tinetti- Performance-Oriented Mobility Assessment (POMA-T)(2 years)
- Falls Efficacy Scale(2 years)
- Validated Spanish version of Short-Form Late-Life Function and Disability Instrument(2 years)