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临床试验/NCT03687840
NCT03687840已完成不适用

Evaluation of Spatio-Temporal Gait Parameters and Gait Symmetry In Diabetic Polyneuropathic Individuals With Lower Extremity Burn Injury

Recep Tayyip Erdogan University Training and Research Hospital4 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2017年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
4
主要终点
Step Length

研究概览

简要总结

This study evaluated the spatio-temporal gait parameters and gait symmetry in individuals with lower extremity burn injury due to diabetic polyneuropathy. Study group consisted of 14 subjects with unilateral lower extremity burn injuries due to diabetic polyneuropathy and control group consisted of 14 subjects with only diabetic polyneuropathy.

详细描述

Diabetic polyneuropathy, a frequent complication of diabetes, is used to describe sensory, motor and autonomic nerve damage caused by metabolic and micro vessel alterations due to hyperglycaemia. The signs and symptoms of diabetic polyneuropathy vary according to the type of nerve fiber affected. The involvement of the small nerve fibers results in deterioration of the pain and temperature perception, while the impairing of large nerve fibers result in decrease of touch and proprioception sensations. Due to the sensory loss, accidental foot injuries may develop in patients with diabetic polyneuropathy. While the feet constitute a small percentage (3.5%) of the total body surface area, burn injuries of them in patients with diabetic polyneuropathy can cause significant effects on quality of life because impaired wound healing process in diabetics may cause risk of prolonged bed rest and hospitalization period, and increased early and late complications. Therefore, it has an important effects on daily living activities because it causes inadequacies in gait and balance activities due to the negative effects on mobility and weight bearing functions. In studies that examining changes in gait parameters in other diabetic foot complications such as sensory loss, ulceration, and amputation as secondary to diabetic polyneuropathy have shown that these individuals acquire a protective adaptive gait strategies that allow for more controlled gait in the present of proprioceptive deficits such as slower gait speed, smaller step length and in particular increased opposite foot off time in order to shift body weight from injured limb to unaffected side. There's no studies have yet been conducted to investigating of changes in gait parameters in patients who have diabetic polyneuropathy-related lower extremity burn injury. The aim of this case-control study is to examine whether similar gait strategies have been gained in this group of patients, as indicated in the results of previous studies demonstrating protective adaptive gait strategies that adopt under the presence of other diabetic foot complications due to diabetic polyneuropathy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Study group, include cases with a diagnosis of diabetic polyneuropathy and unilateral lower limb burn injury.
  • Control group consists of adults with a confirmed diagnosis of diabetic polyneuropathy without burn injury.

排除标准

  • presence of active ulcerations
  • presence of other diabetic morbidities (nephropathy, retinopathy, vestibulopathy)
  • orthopedic, musculoskeletal, neurological problems or previous surgical interventions that may affect the mobility and original gait dynamics except for diabetic polyneuropathy,
  • using of assistive devices
  • body mass index> 40 kg/m²

研究组 & 干预措施

Study Group

Other

Spatio-Temporal gait analysis of subjects with unilateral lower extremity burn injuries due to diabetic polyneuropathy.

干预措施: gait analysis (Diagnostic Test)

Control Group

Other

Spatio-Temporal gait analysis of subjects with only diabetic polyneuropathy.

干预措施: gait analysis (Diagnostic Test)

结局指标

主要结局

Step Length

时间窗: 1 week

It is measured along the length of the walkway, from the heel center of the current footprint to the heel center of the previous footprint on the opposite foot.The unit of measure is centimeters.

次要结局

  • Stride Length(1 week)
  • Speed(1 week)
  • Cadence(1 week)
  • Step Width(1 week)
  • Percentage of Double Support(1 week)
  • Percentage of Swing(1 week)
  • Symmetry Index(1 week)
  • Foot Progression Angle(1 week)
  • Percentage of Stance(1 week)

研究者

发起方
Recep Tayyip Erdogan University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melek Merve ERDEM

Research Assistant

Recep Tayyip Erdogan University Training and Research Hospital

研究点 (4)

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