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临床试验/NCT05945953
NCT05945953已完成不适用

Comparison of Incentive Spirometer as a Visual Feedback Versus Deep Breathing Via Mirror Mediated Therapy on Pulmonary Function in Children With Spastic Cerebral Palsy

Riphah International University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年9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
54
试验地点
1
主要终点
Forced Expiratory Volume in 1 second (FEV1)

研究概览

简要总结

Objective: To compare the effects of incentive spirometer as a visual feedback versus deep breathing via mirror mediated therapy on pulmonary function in children with spastic cerebral palsy. To determine the effects of incentive spirometer as a visual feedback versus deep breathing via mirror mediated therapy on sleep and quality of life in children with spastic cerebral palsy.

研究设计

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

入排标准

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

入选标准

  • Participants falling in this category would be recruited into the study.
  • Spastic diplegic, age above
  • According to modified Ashworth scale, moderate spasticity 1 to
  • Adequate cognition (will be assessed by using MMSE scale) in order to follow the instructions to use Incentive Spirometry and also able to comprehend single verbal command for breathing.
  • Able to attend all sessions. (mentally and physically capable of attending session).
  • Able to sit with support.

排除标准

  • Participant falling in this category would be excluded of the study.
  • Patients with any respiratory or cardiac disease that can affect their respiratory function.
  • Patients with beta blockers or bronchodilators.
  • Children with any cognitive impairment who are unable to follow instructions.
  • Children with bone deformities, such as scoliosis or kyphosis.
  • Children with any sort of auditory and visual defects.

结局指标

主要结局

Forced Expiratory Volume in 1 second (FEV1)

时间窗: 6 weeks

Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

Forced vital Capacity (FVC)

时间窗: 6 weeks

Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

Peak Expiratory Flow (PEF)

时间窗: 6 weeks

Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second

次要结局

  • Quality of life questionnaire for children (CPQOL-Child)(6 weeks)
  • Sleep (Sleep Disturbance Scale-SDSC)(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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