The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Postural Balance
研究概览
简要总结
Postural control and plantar pressure are affected by many parameters in diabetic individuals. It is considered important to examine the relationship between changes in plantar pressure distribution and postural balance, physiological expenditure index and gait parameters in diabetic individuals. Within the scope of this project, based on the above mentioned reasons, we plan to produce a personalised off loading insoles designed for diabetic foot.
详细描述
Excessive localized loading on the plantar surface leads to repeated microtrauma and the development of diabetic foot ulcers. The plantar region, subjected to constant weight-bearing pressure, develops chronic wounds due to dangerous vascularity. Excessive plantar pressure is considered the primary risk factor for plantar ulcers in diabetic individuals; custom insoles are considered the gold standard in treatment for off-loading plantar pressure.
The off-loading technique, which reduces plantar pressure, is an effective ulcer prevention strategy for neuropathic feet with impaired sensation and increased plantar load and tissue stress.
A review of the literature shows that previous studies have clearly demonstrated that off-loading insoles are effective in reducing abnormal plantar pressure in a specific area and that they also have some effect on the pressure distribution in surrounding areas. However, the potential impact of this positive effect on postural balance, postural control, and individuals' physiological expenditure and energy consumption has not been sufficiently studied.
Therefore, it is considered important to investigate the relationship between changes in plantar pressure distribution, postural balance, physiological expenditure index, and walking parameters in diabetic individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 35 and 70,
- •Wagner Classification stages 0 or 1,
- •He has type I or type II diabetes,
- •No history of amputation surgery,
- •Individuals using shoes suitable for insoles will be included in the study.
排除标准
- •- Using an assistive device (long-walking device, walker, canadiene, etc.),
- •He has a history of amputation,
- •He has a Charcot foot deformity,
- •The one with the open wound,
- •Physical disability that may restrict joint movement,
- •Individuals using shoes that are not suitable for insoles will not be included in the study.
研究组 & 干预措施
All participants
Using diabetic insole and will participate in all assessment methods.
干预措施: Insole (Other)
All participants
Using diabetic insole and will participate in all assessment methods.
干预措施: Demographic Information and Anamnesis Form (Other)
All participants
Using diabetic insole and will participate in all assessment methods.
干预措施: Pedobarographic analysis (Other)
All participants
Using diabetic insole and will participate in all assessment methods.
干预措施: Postural balance (Other)
All participants
Using diabetic insole and will participate in all assessment methods.
干预措施: The Foot Functional Index (FFI) (Other)
All participants
Using diabetic insole and will participate in all assessment methods.
干预措施: Sensory Evaluation (Other)
All participants
Using diabetic insole and will participate in all assessment methods.
干预措施: Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0) (Other)
All participants
Using diabetic insole and will participate in all assessment methods.
干预措施: Pulse Oximeter Heart Rate and Oxygen Saturation (Other)
All participants
Using diabetic insole and will participate in all assessment methods.
干预措施: 6 Minute Walk Test (6MWT) (Other)
结局指标
主要结局
Postural Balance
时间窗: the evaluation of balance and postural control will be carried out before and in the 3rd month of insoles use and the effects on individuals will be compared.
Postural balance assessment in the study will be performed with 'Becure Balance System (Becure Global GmbH)'. It is planned to perform balance assessment of individuals on the device with eyes open-closed, single foot-double foot. After the participant is positioned on the balance board, balance evaluations will be made in different situations such as eyes open-closed, single foot-double foot. Changes in the centre of gravity on the x and y axes with the eyes open and closed, and changes in postural oscillation will be examined with the results of the distance of movement expressing the changes in the centre of gravity. The postural balance assessment conducted in the study provides all the parameters mentioned above in centimeters. These values represent postural sway.
次要结局
- The Physiological Cost Index (PCI)(Evaluation will be made before and in the 3rd month of insoles use.)
研究者
Yağmur UYSAL
Lecturer
Medipol University