跳至主要内容
临床试验/CTRI/2025/04/085852
CTRI/2025/04/085852尚未招募不适用

Impact of Caregiving on Quality of Life of Caregivers of Cerebral Palsy Patients: A Cross-Sectional study

All India Institute of Medical Sciences, Raebareli1 个研究点 分布在 1 个国家目标入组 373 人开始时间: 2025年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
373
试验地点
1
主要终点
Modified Caregiver Strain Index (MCSI) scale

研究概览

简要总结

Cerebral palsy is a neurodevelopmental disorder. Cerebral palsy (CP) is an umbrella term for a group of disorders of movement and posture, caused by a non-progressive interference in the developing brain. Risk factors for CP varies from prenatal period to antenatal period for up to 2 years. Known risk factors are genetic variants, congenital anomalies, preterm birth, kernicterus, intrauterine growth restriction and infection, hypoxic ischemia and cerebrovascular insults during pregnancy and in infancy, and accidental and non-accidental brain injury.

Although the prevalence of cerebral palsy is decreasing in high income countries but in developing countries prevalence is still high. In low to middle income countries, the prevalence is 3.4 per 1000 live births. This is only a tip of

Sampling Technique

Consecutive sampling will be employed to select study participants from patients attending the Outpatient Department (OPD) of a tertiary care hospital. Individuals meeting the inclusion and exclusion criteria will be finally enrolled in the study after providing informed written consent.

Study Plan

Written consent will be taken. Caregiver demographic data will be recorded in a working proforma. After that they will be evaluated for inclusion and exclusion criteria. Caregivers will be evaluated using 2 questionnaires. Quality of Life will be assessed using WHOQOL-BREF. Care giver strain will be evaluated using Modified Caregiver Strain Index (MCSI).

Questionnaire

Modified Caregiver Strain Index (MCSI) scale

Measure caregiver burden. An Ordinal scale which is valid and reliable with 13 questions. The Internal reliability coefficient of 0.90.

World Health Organization Quality of Life Brief Scale (WHOQOL-BREF)

Developed by the Word Health Organization as a quality of life assessment that would be applicable cross-culturally. It is a 26 item, self-reported measure, especially useful for measuring outcomes with adults with a psychosocial disability. The Internal reliability coefficient of 0.92.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Must be a caregiver of Cerebral Palsy patient.
  • •Age of caregiver of CP patient more than 18 years and less than 60 years.

排除标准

  • •Patient on a rehabilitation protocol from any other place or institute.
  • •Caregivers who do not want to take part in study, private caregivers, patient suffering from any other musculoskeletal or neurological comorbidity not associated with CP like spinal cord injury, traumatic brain injury, cancer, amputations and rheumatological disorders.
  • •Pregnant female caregivers.
  • •Caregiving of more than one patient or taking any mental health care.

结局指标

主要结局

Modified Caregiver Strain Index (MCSI) scale

时间窗: One time through questionnaire since it is a cross sectional study

次要结局

  • World Health Organization Quality of Life Brief Scale (WHOQOL-BREF)(One time through questionnaire since it is a cross sectional study)

研究者

发起方
All India Institute of Medical Sciences, Raebareli
申办方类型
Government medical college

研究点 (1)

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