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临床试验/CTRI/2023/12/060714
CTRI/2023/12/060714招募中2 期

Effect of Myofascial Release Techniques Vs Conventional Physiotherapy on Pulmonary Function in children with Spastic Cerebral Palsy in the age group of 6 to 12 years- A Randomized Controlled Trial

Dr Harshada Kumbhar Sonawane1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
68
试验地点
1
主要终点
Pulmonary function tests FVC, FEV1, PEFR, FEV1/FVC

研究概览

简要总结

Children with spastic cerebral palsy in the age group of 6 to 12 years will be assessed for pulmonary function before, at 4 weeks and at 8 weeks post intervention of Myofascial Release techniques along with conventional physiotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children diagnosed with Spastic Cerebral Palsy
  • Age 6 to 12 years
  • Both genders
  • GMFCS level I, II, III
  • Able to sit without support for approximately 30 minutes.
  • Able to close mouth (lips) around the mouthpiece of Spirometer and Micro RPM devices.
  • Able to understand and follow simple commands.
  • Willing to participate in study.

排除标准

  • Any other neurological or genetic condition which delays overall development of the child.
  • Any musculoskeletal conditions like fixed spinal deformities, chest deformities (Pectus Excavatum).
  • Any cardiac conditions like CHD.
  • Any Respiratory Conditions like Asthma, Cystic fibrosis.
  • Moderate to Severe Cognitive dysfunction.
  • Children with cerebral Palsy having moderate to severe visual and auditory impairments.
  • Children with cerebral Palsy having status epilepticus or severe affection due to epilepsy/ recent episodes of seizures/ frequent seizures.
  • Any invasive treatment procedure/surgery performed during last 6 to12 months.
  • Severe Oromotor Dysfunction.
  • Children with Athetoid/Ataxic/Hypotonic type of Cerebral Palsy.

结局指标

主要结局

Pulmonary function tests FVC, FEV1, PEFR, FEV1/FVC

时间窗: Baseline, 4 weeks, 8 weeks

次要结局

  • Maximum Inspiratory Pressure (MIP) cmH2O & Maximum Expiratory(Pressure (MEP) cmH2O)
  • Chest Expansion measurements in centimeters(cm)

研究者

发起方
Dr Harshada Kumbhar Sonawane
申办方类型
Other [Self Funded]
责任方
Principal Investigator
主要研究者

Dr Harshada Kumbhar Sonawane

Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy

研究点 (1)

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