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CTRI Number  CTRI/2024/05/067924 [Registered on: 27/05/2024] Trial Registered Prospectively
Last Modified On: 09/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on knowledge, attitude and practice of parents of children with cerebral palsy 
Scientific Title of Study   A cross-sectional study on knowledge, attitude and practice of parents of children with cerebral palsy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajwanti vaswani 
Designation  Professor 
Affiliation  Seth G. S. Medical College & KEM Hospital 
Address  Department of Pediatrics, Seth G. S. Medical College & KEM Hospital, Old KEM Building, Ward No. 2, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  24107626  
Fax    
Email  anukvaswani@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajwanti vaswani 
Designation  Professor 
Affiliation  Seth G. S. Medical College & KEM Hospital 
Address  Department of Pediatrics, Seth G. S. Medical College & KEM Hospital, Old KEM Building, Ward No. 2, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  24107626  
Fax    
Email  anukvaswani@hotmail.com  
 
Details of Contact Person
Public Query  
Name  vimlesh 
Designation  Junior Resident 
Affiliation  Seth G. S. Medical College & KEM Hospital 
Address  Department of Pediatrics, Seth G. S. Medical College & KEM Hospital, Old KEM Building, Ward No. 2, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  9873661104  
Fax    
Email  vimleshkumari2197@gmail.com  
 
Source of Monetary or Material Support  
Seth G S Medical College and KEM Hospital, Parel, Mumbai 400012, Maharastra, INDIA 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Rajwanti Vaswani  Seth G S Medical College and KEM Hospital  Ward 2 Department of Pediatrics, Old KEM Hospital Building, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 24107626

anukvaswani@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Parents of children diagnosed with cerebral palsy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria
Modification(s)  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Parents of children aged between 1 to 12 years diagnosed with cerebral palsy 
 
ExclusionCriteria 
Details  1. Parents who have not given consent to participate in the study
2. parents of children who are admitted in the PICU. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To assess knowledge of parents of children with cerebral palsy
2.To determine the attitude of parents of children with cerebral palsy
3.To assess the practices of parents of children with cerebral palsy 		 8weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To find the association of knowledge, attitude, & practices with demographic variables  8weeks 
 
Target Sample Size   Total Sample Size="133"
Sample Size from India="133" 
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)   01/06/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Aims and Objectives:
primary objective
  1. To assess the knowledge of parents of children with cerebral palsy. 
  2. To determine the attitude of parents of children with cerebral palsy.
Secondary objective
To assess the practices of parents of children with cerebral palsy.
Materials and Methods:

Ethics: The study will be initiated after seeking approval from the “Institutional Ethics Committee (IEC)”. The study will be conducted in compliance with the “Ethical Guidelines for Biomedical Research on Human Participants” by the Indian Council of Medical Research.

Consent: Case enrolment will be done after a written informed consent is obtained from the parents of patients. 

Study Design: A single Centre, cross-sectional study comprising data collected prospectively over one year. 

Study site: The study will be conducted in patients attending Pediatric General and Epilepsy OPD and admitted in wards. 

Confidentiality: The participant’s details will not be disclosed at any point of time. Also, during publication of the data, all care will be taken to not disclose the details of the individual participants/subjects.  

Study Population: Parents of children aged between 1- 12 years with cerebral palsy. 

Study duration: The study will be conducted for a period of 18 months (after approval from IEC). 

Inclusion Criteria:  

1.     Parents of children aged between 1-12 years. 

2.     Children diagnosed with cerebral palsy. 

Exclusion Criteria: Parents who have not given consent to participate in the study. 

Sample size calculation: Purposive sampling is done for the given study. Parents of children with cerebral palsy visiting Pediatric General and Epilepsy outpatient department (OPD) admitted in wards during the study period. Based on inclusion and exclusion criteria will be included in the study. Based on previous 3 years data approximately 7-8 cerebral palsy patients including indoor and outdoor patients visit hospital each month. By the given data if we consider 8 patients per month, in 15 months there will be approximately 133 cerebral palsy patients. sample size for the study is 133 participants, accounting for 10% attrition rate.

Study Procedure:  

      Diagnosed cases of cerebral palsy visiting Pediatric General and Epilepsy OPD and admitted in wards will be enrolled in the study as per the inclusion criteria

     Those who fulfil the criteria, written informed consent will be obtained from their parents/guardian. 

   Once consent has been obtained, ICD (informed consent document) will be signed. One copy will be retained by the principal investigator and a copy of ICD will be given to patient’s parents. Each patient will be assigned a unique study identification number. 

   Data will be collected in a case record form by the interviewer herself. 

Study tool: A structured questionnaire is developed to collect the data. Which is validated by the team of experts. The questionnaire consists of following parts. 

Part A: Case Record Performa to record socio demographic variables of the child and parents.

Part B: structured questionnaire which consist of following parts. 

i.              To assess knowledge of parents regarding cerebral palsy.

ii.            To measure the level of attitude, four-point Linkert scale is used. Each response will be noted as positive or negative attitude.

iii.          Observational checklist of practice of parents.

Statistical Analysis:

     Descriptive statistics will be described in counts/percentages for categorical variables.

  Numerical variables like demographic and clinical profile will be expressed as mean+- standard deviation (SD). 

 Outcome will be assessed by using chi-square test. 

 P<0.05 as significant.

The data will be analyzed using the statistical package for social sciences (SPSS) Version 25.0 

 

Vancouver style Referencing

1.    K. Vitrikas, H. Dalton, and D. Breish, Cerebral palsy: an overview.American Family Physician.2020;101(4):213-220. 

2.    Mac Keith RC, Mackenzie I, Polani P. The Little Club. Memorandum on terminology and classification of cerebral palsy. Dev Med Child Neurol.1959; 1:27-35. Doi: 10.1111/j. 1469-8749. 1959.tb08073.x 

3.    Bax M. Terminology and classification of cerebral palsy. Dev Med Child Neurol.1964; 6:295-297.  

4.    Bax M, Goldstein M, Rosenbaum P, et al. Executive Committee for the Definition of cerebral palsy. Proposed definition and classification of cerebral palsy. Dev Med Child Neurol. 2005;47(8):571-576. doi:10.1017/S001216220500112X 

5.    Rosenbaum P, Paneth N, Leviton A, et al. A report: the definition and classification of cerebral palsy. Dev Med Child Neurol.2007; 109:814. 

6.    Cans C, Dolk H, Platt MJ, Clover A, Prasaukiene A, Krageloh-Mann I; SCPE collaborative group. Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. Dev 

Med Child Neurol Supp. 2007; 109:35-38. doi: 10.1111/j.14698749. 2007.tb12626.x 

7.    Arneson CL, Durkin MS, Benedict RE, et al. Prevalence of cerebral palsy: autism and developmental disabilities monitoring network, three sites, United states, 2004. Diabil Health J.2009; 2:45-8. 

8.    Bhasin T, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 yearsMetropolitan disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Sumn.2006;55:1-9. 

9.    Paneth N, Hong T, Korzeniewksi S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006; 33:251-67. 

10.Winter S, Autry A, Boyle C, Yeargin-Allsopp M. Trends in the prevalence of cerebral palsy in a population-based study. Pediatrics. 2002; 110:1220-5. 

11.Chauhan A, Singh M, Agarwal A, Sahu JK, Singh M. Prevalence of cerebral palsy in Indian children: a systematic review and metanalysis. Indian J Pediatr.2019;86(12):1124-1130.

12.Eicher PS, Batshaw ML. Cerebral palsy. Pediatr Clin North Am.1993; 40: 537-551. 

13.Rosenbaum P. Cerebral palsy: what parents and doctors want to know. BMJ 2003; 326: 970-974. 

14.Murphy N, Such-Neibar T. Cerebral palsy diagnosis and management: the state of art. Curr Probl Pediatr Adolesc Health Care. 2003;33: 146-169. 

15.Novak I, Morgan C, Adde L, et al. Early, accurate diagnosis and early intervention in cerebral palsy: advances in diagnosis and treatment. JAMA Pediatr. 2017;171(9):897-907. 

16.Ashwal S, Russman BS, Blasco PA, et al. Practice parameter: diagnostic assessment of the child with cerebral palsy: report of the quality standards subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2004;62(6):851-863. 

17.Karande S, Patil S, and Kulkarni M.Impact of an educational program on parental knowledge of cerebral palsy. Indian journal of Pediatrics, 2008;75(9):901-906. 

18.World Health Organization, Promoting the Development of Young Children with Cerebral Palsy, 1993, http://whqlibdoc.who.int/hq/1993/WHO_RHB_93.1.pdf.

19.Amiri A, Kalantari M, Rezaee M, Akbarzadeh Baghan A Ghareshloo F. Effect of Child Factors on Parental Attitude Towards Children and Adolescents with Cerebral Palsy in Iran. Iranian Rehabilitation Journal. 2019;17(4):319-330. 

20.Kaliyaperumal K. Guideline for Conducting Knowledge, Attitude and Practice (KAP) Study. Community Ophthalmology, 2004;4(1): 7-9. 

 

 
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