Effects of Plantar Cutaneous Sensory Stimulation on Foot Tactile Sensitivity, Postural Control, and Spatiotemporal Gait Parameters in Patients With Diabetic Neuropathy
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
- Foot tactile sensitivity
研究概览
简要总结
To determine the effects of plantar cutaneous sensory stimulation on foot tactile sensitivity, postural control, and spatiotemporal gait parameters in patients with diabetic neuropathy.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranged between 45-67 years.
- •Both male and female genders are included.
- •DM for the past 7 years.
- •Scored > 2/13 on the Michigan Neuropathy Screening Instrument (MNSI) questionnaire including at least two DPN symptoms.
- •Scored >1/10 on MNSI physical assessment including impaired vibration perception
排除标准
- •Loss of protective foot sensation (defined as a lack of response to the monofilament of the sensory evaluation instrument).
- •Comorbidities include visual impairment, cerebrovascular accident, orthopedic trauma, labyrinthitis, peripheral vascular disease, and heart failure.
- •Foot ulcers, orthopedic or surgical problems in a lower limb, other neurological impairment.
- •Use of assistive devices for ambulation.
- •Inability to walk independently with or without an assistive device.
- •Receiving any structured supervised physiotherapy intervention
研究组 & 干预措施
Traditional physical therapy
This group received conventional physical therapy protocol along with foot care guidelines.
干预措施: Traditional physical therapy (Other)
Plantar cutaneous sensory stimulation.
This group received plantar cutaneous sensory stimulation along with conventional physical therapy protocol and foot care guidelines.
干预措施: Plantar cutaneous sensory stimulation (Other)
结局指标
主要结局
Foot tactile sensitivity
时间窗: 6th week
Semmes Weinstein monofilaments, Foot tactile sensitivity loss, commonly assessed by monofilaments, is a fall risk factor among older adults. The broadly used threshold of the monofilament for fall risk assessment in older adults is 5.07
Postural control
时间窗: 6th week
Brief BESTest is a clinical balance assessment tool. It is an abbreviated version of Balance Evaluation Systems Test (BESTest) designed to assess 6 different aspects contributing to postural control in standing and walking. It consist of 27 tasks, with 36 items in total. Each items is scored based on ordinal scale scoring from 0- 3 where 3 representing best performances and 0 representing worst performances. Scores for the total test is provided as a percentage of total points i.e. 108. In addition, 6 sub-systems scores can be generated separately in percentage of total score each representing a specific balance system
Spatiotemporal gait parameters
时间窗: 6th week
By using a stopwatch and measuring tape
次要结局
未报告次要终点