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临床试验/NCT06326593
NCT06326593已完成不适用

Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn

MTI University3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年2月22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
80
试验地点
3
主要终点
Forced vital capacity (FVC)

研究概览

简要总结

Inhalation injury is a composite of multiple insults including: supra glottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.

Wii fit aerobic training gives similar results with traditional rehabilitation practices, it causes less energy costs. This suggests that it can be a suitable rehabilitation tool for adult and elderly people with low energy levels. A review showed that video games are safe and feasible in the children with lung complications. Children' balance, aerobic and cognitive functions, quality of life improved and depressive mood decreased. WII aerobic games also make children to communicate better with other family members.

详细描述

This study will investigate the effects of Wii aerobic training in Inhalation-injury Children post-thermal burn. To assign patients to different treatment groups, a table of random numbers generated by a computer was used. Patients were allocated randomly into one of three groups using this method. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, Om El masryeen hospital and Embaba general hosbital after referral from dermatologist. Children will perform these exercises in a room supervisor physiotherapist.

All parents of children will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

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)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA), Burn size was measured using modified Lund and Browder charts.
  • 12 Years to 17 Years (Child )
  • Inhalation injury.
  • All children suffering from retained secretions which did not respond to medical treatment.
  • All children should be clinically and medically stable.
  • All children should have the same medical treatment.

排除标准

  • Children with any dysfunction that limit physical activity such as neurological disorders, chronic obstructive pulmonary disease, malignancy, cardiovascular diseases, orthopedic problems, such as fracture on the pelvic or limbs, a visual impairment, brain injury or hearing impairments and contractures.
  • Children use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit.
  • Children with other hormonal diseases

结局指标

主要结局

Forced vital capacity (FVC)

时间窗: base line and 12 weeks.

Forced vital capacity (FVC) will be measured by using spirometer (SP - 10 electronic hand held spirometer ) with the subject upright sitting or lying in the supine posture

forced expiratory volume in 1 second (FEV1)

时间窗: base line 12 weeks

forced expiratory volume in 1 second (FEV1) will be measured by using spirometer(SP - 10 electronic hand held spirometer) with the subject upright sitting or lying in the supine posture

peak expiratory flow (PEF)

时间窗: base line 12 weeks

peak expiratory flow (PEF) will be measured by using spirometer(SP - 10 electronic hand held spirometer ) with the subject upright sitting or lying in the supine posture

次要结局

  • Upper and lower chest expansion (2nd intercostal space, xiphoid)])(base line 12 weeks)
  • Functional capacity 6-Minute Walk Test (6-MWT)(base line 12 weeks)
  • Timed Up and Go test (TUG)(base line 12 weeks)

研究者

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

Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d

lectrurer of physical therapy for general surgery and dermatology

MTI University

研究点 (3)

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