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临床试验/NCT04350034
NCT04350034已完成不适用

Xbox Kinect™ to Promote Physical Fitness and Lean Mass in Severely Burned Children: A Randomized Controlled Trial

Qassim University0 个研究点目标入组 40 人开始时间: 2016年6月15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
40
主要终点
VO2 peak

研究概览

简要总结

The outcome measures included quadriceps muscle strength as measured using an isokinetic dynamometer, LBM is measured by DEXA and cardiopulmonary fitness was assessed by measuring VO2 peak during a standardized treadmill exercise test using the modified Bruce protocol. All outcome measures were evaluated immediately after discharge as baseline and after 12 weeks of intervention.

详细描述

Forty healed pediatric burn patients (24 boys and 16 girls), aged 10 - 15 years, were enrolled from the outpatient clinic in the faculty of physical therapy, Cairo university, Egypt. The inclusion criteria were: total body surface area (TBSA) of 40-60%, being ambulatory without an assistant. The exclusion criteria included metabolic disorders, neuropathy, visual or vestibular disorders, amputation, participation in another study, any adverse medication reactions, history of epilepsy, loss of balance, and lower or upper limb deformity. All patients received similar standard medical care and treatment from the time of admission until the time of discharge.

Total burn surface area was assessed by the "modified Lund and Browder charts" method during excisional surgery immediately following hospital admittance. Informed written consent was obtained from each patient's guardian prior to enrollment.

All procedures were approved by the ethical committee of the faculty of physical therapy, Cairo university, Giza, Egypt. After consent was obtained, patients were randomly assigned to standard of care group (SOC) or Xbox training group (Xbox).

The Xbox group participated in a 12-week of routine physiotherapy program supplemented with Xbox training program (N=20). In contrast, the SOC group participated in the routine physiotherapy program (N=20).

A normal activity of daily living (ADL), diet and patient's lifestyle were maintained for all participants as much as possible.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • total body surface area (TBSA) of 40-60%.
  • being ambulatory without an assistant.

排除标准

  • metabolic disorders.neuropathy.
  • visual or vestibular disorders.
  • amputation.
  • participation in another study.
  • history of epilepsy.
  • loss of balance.
  • lower or upper limb deformity.

结局指标

主要结局

VO2 peak

时间窗: after 12 weeks of treatment

determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.

次要结局

  • Isokinetic testing Muscle strength(after 12 weeks of treatment)

研究者

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

Maged Basha

Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt.

Qassim University

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