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CTRI Number  CTRI/2025/04/085852 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study the effect of caregiving among caregivers of patients with Cerebral Palsy 
Scientific Title of Study   Impact of Caregiving on Quality of Life of Caregivers of Cerebral Palsy Patients: A Cross-Sectional study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Satyasheel Singh Asthana 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satyasheel Singh Asthana 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Satyasheel Singh Asthana 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raebareli 
Address  All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Satyasheel Singh Asthana  All India Institute of Medical Sciences, Raebareli  Room 22/28, Ground floor, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405
Rae Bareli
UTTAR PRADESH 
9169385726

satyapmr2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), AIIMS Raebareli, Uttar Pradesh, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary caregivers of children with Cerebral Palsy, including their parents or guardian 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL   NIL since it is an observational cross-sectional questionnaire based study 
Comparator Agent  NIL  NIL since it is an observational cross-sectional study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Must be a caregiver of Cerebral Palsy patient.
Age of caregiver of CP patient more than 18 years and less than 60 years. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Modified Caregiver Strain Index (MCSI) scale  One time through questionnaire since it is a cross sectional study 
 
Secondary Outcome  
Outcome  TimePoints 
World Health Organization Quality of Life Brief Scale (WHOQOL-BREF)  One time through questionnaire since it is a cross sectional study 
 
Target Sample Size   Total Sample Size="373"
Sample Size from India="373" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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