| 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
|
|
|
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
|
|
|
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. |