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临床试验/NCT04587102
NCT04587102已完成不适用

Whole Body Vibration Training for Diabetic Patients With Burn Injury: RCT

Cairo University5 个研究点 分布在 2 个国家目标入组 38 人开始时间: 2019年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
5
主要终点
Dynamic balance assessment

研究概览

简要总结

Burn injury as well as diabetes mellitus (DM) induce physical functional and psychological impairments. Lower limb burn involving Foot are still a challenging heath condition because of its important sensory role. Balance is disturbed either in patients with lower limb burn injury or diabetic patients. This study aime to compare between the effects whole body vibrational training and Yoga exercises on postural balance, and Activities-specific Balance Confidence in in type II diabetic Patients with foot burn

详细描述

Thirty eight diabetic patients (17 male, 21female) with foot burn injury, with their age ranged from 40 to 55 years. They will randomly assigned into two equal groups. Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks (n=19), while group (B) the control group for 8 weeks (n=19) in addition both groups will receive their routine medical care and physical therapy rehabilitation including balancing exercises. Dynamic balance will be evaluated through Biodex balance system (BBS);and balance confidence will be measured by the Activities-specific Balance Confidence Scale (ABC) before the starting and after the end of treatment for all patients in both groups

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
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • chronic lower limb burns injury for more than 6 months
  • Total body surface area (TBSA) burnt ≤ 30%.;

排除标准

  • cognitive or mentality dysfunctions,
  • psychiatric conditions,
  • fractures,
  • pregnancy,
  • severe vascular complications,
  • inability to walk

结局指标

主要结局

Dynamic balance assessment

时间窗: Change from Baseline at balance scores at 8 weeks

Biodex Balance System was used to measure the dynamic balance of each patient in both groups (A and B) before and after 8 weeks of treatment. The system has a movable balance platform that permits about 20◦ tilt in 360◦ range, and is interfaced with computer software for objective balance assessment. It measures the ability of the patient to control the platform's tilting angle, which is quantified as a variation from the center, as well as the deflection degree over time at different stability levels

次要结局

  • The Activities-specific Balance(Change from Baseline at Activities-specific Balance scores at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ZIZI MOHAMMED IBRAHIM ALI

Assistant Professor of physical therapy, Department of Physical Therapy for Burn and Plastic Surgery, Faculty of Physical Therapy, Cairo University, Egypt.

Cairo University

研究点 (5)

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