跳至主要内容
临床试验/NCT05608954
NCT05608954招募中不适用

Effects of Physical Therapy on the Multisystems of Children With Cerebral Palsy: a Longitudinal Study

Federal University of Health Science of Porto Alegre1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2022年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
33
试验地点
1
主要终点
Gross Motor Function

研究概览

简要总结

Cerebral Palsy (CP) refers to childhood movement and posture disorders, whose severity, patterns of motor involvement and associated impairments are very varied. It is the most prevalent type of physical disability in children. Any non-progressive central nervous system (CNS) lesion that occurs in the prenatal, perinatal and postnatal period up to 2 years of life is considered CP. Thus, the present work aims to evaluate, monitor and verify the effects of physical therapy interventions on gross motor function, spasticity, balance, muscle activation, fatigue, respiratory system, functionality and social participation in children with cerebral palsy. This work will use some evaluation scales such as the Gross Motor Function Measure (GMFM-66), the Modified Ashworth Scale (MAS), the Early Clinical Assessment of Balance (ECAB), electromyography, the Fatigue Severity Scale and the Pediatric Functional Status. Scale. In addition to questionnaires, which will be applied directly to parents/caregivers, such as the Young Children's Participation and Environment Measure (YC-PEM), the PEDI (Pediatric Evaluation Disability Inventory) and the Goal Attainment Scaling (GAS).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • clinical diagnosis of Cerebral Palsy
  • aged between 0-12 years
  • classified in all the levels of the GMFCS
  • those responsible agree to release the minor to participate in the study and sign the Free and Informed Consent Form (FICT)

排除标准

  • have had botulinum toxin applied 6 months before the intervention
  • recent surgery
  • other physical abnormalities, genetic or severe syndromes.

结局指标

主要结局

Gross Motor Function

时间窗: 1 year

Measurement of Gross Motor Function

Gross Motor Function Classification System

时间窗: Levels I - V. Higher scores mean a worse outcome

Scale Gross Motor Function Classification System

次要结局

  • Electromyography(1 year)
  • Fatigue Severity Scale(1 year)
  • Early Clinical Assessment of Balance - ECAB(1 year)
  • Modified Ashworth Scale (MAS)(1 year)
  • YC-PEM - Young Children's Participation and Environment Measure(1 year)
  • Pediatric Functional Status Scale(1 year)
  • PEDI (Pediatric Evaluation Disability Inventory)(1 year)
  • GAS (Goal Attainment Scaling)(1 year)

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernanda Cechetti

Professor

Federal University of Health Science of Porto Alegre

研究点 (1)

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