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临床试验/CTRI/2024/06/069085
CTRI/2024/06/069085尚未招募不适用

Correlation between quality of life and hand function in children with cerebral palsy of age group 4-12 years

Physiotherapy school and Centre Seth G S Medical College and KEM Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Manual Ability Classification System

研究概览

简要总结

Cerebral palsy is a motor disability which is non-progressive and is caused by damage to CNS at or around birth. The CPQOL child is a condition specific QOL Questionnaire designed for children with CP. Primary Caregiver questionnaire evaluating seven domains appears to have very good reliability and validity. We are using a primary caregiver proxy report for children aged 4–12 years is parent reported version of CPQOL in this study. The Manual Ability Classification System (MACS) describes how children with cerebral Palsy (CP) use their hands to handle objects in daily activities. MACS describes five Levels .MACS can be used for children aged 4–18 years. For MACS the Interrater reliability between the parent and therapist was excellent (ICC between parents and therapists was 0.96) and Interrater reliability between therapists was excellent (ICC was 0.97). This Study is Correlation and Observational study and  study duration will be 1 year. Study population will be children with CP who will visits at pediatric neuro physiotherapy opd between period of July 2024 to February 2025.

This  study will be conducted during routine treatment session of the child. Written consent will be explained to parents and signed by the parents, guardians of the subjects explaining purpose of the study. CPQOL hard copies will be given to the parents of cerebral palsy children , parents should answer the questionnaire and return it back to the investigator in 15-20 minutes. MACS assessment  will be done in routine OPD in this therapist should observed how child with cerebral palsy use their hand to handle objects and according to that  grading will be recorded .The levels are based on the children’s ability to handle objects and their need for assistance to perform manual activities. For assessment colorful, different size toys used to find out MACS score. Data will be collected and statistically analyzed.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • The participants will be parents of children with cerebral palsy of age group 4-12 years visiting a paediatric neuro OPD, Epilepsy care clinic on Tuesday and paediatric medicine OPD on Thursday at tertiary care hospital between period of July 2024 to February
  • The parents will be able to read and understand either of these three languages English, Hindi, Marathi.

排除标准

  • The parents who are not willing to participate.

结局指标

主要结局

Manual Ability Classification System

时间窗: Once at baseline

次要结局

  • Cerebral Palsy Quality Of Life Questionnaire(Once at baseline)

研究者

发起方
Physiotherapy school and Centre Seth G S Medical College and KEM Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Archana Gore

Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai

研究点 (1)

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