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CTRI Number  CTRI/2023/07/054657 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 03/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Making of a simulation doll for teaching and treatment purpose and checking the usability 
Scientific Title of Study   Design, development and usability of simulation doll for paediatric therapy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubha R Nayak 
Designation  Assistant Lecturer 
Affiliation  MANIPAL COLLEGE OF HEALTH PROFESSIONS 
Address  Department of Physiotherapy, Manipal College of Health Professions,Manipal Academy of Higher Education,Maniapl
Same as address 1
Udupi
KARNATAKA
576102
India 
Phone  8660601179  
Fax    
Email  shubha.ram@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  SHUBHA R NAYAK 
Designation  Assistant Lecturer 
Affiliation  MANIPAL COLLEGE OF HEALTH PROFESSIONS 
Address  Department of Physiotherapy, MCHP,MAHE
MCHP,MAHE
Udupi
KARNATAKA
576102
India 
Phone  8660601179  
Fax    
Email  shubha.ram@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  SHUBHA R NAYAK 
Designation  Assistant Lecturer 
Affiliation  MANIPAL COLLEGE OF HEALTH PROFESSIONS 
Address  Department of Physiotherapy,Manipal College of Health Professions, Maniapl Academy of Higher Education MAHE
Same as address 1
Udupi
KARNATAKA
576102
India 
Phone  8660601179  
Fax    
Email  shubha.ram@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Kasturba Hospital, Manipal. 
 
Primary Sponsor  
Name  Self 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Other [self] 
 
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 
SHUBHA R NAYAK  Kasturba Hospital   Department of Physiotherapy
Udupi
KARNATAKA 
8660601179

shubha.ram@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy pediatric therapists who are willing to participate in the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  More than 1 year of pediatric physiotherapy and occupational therapy clinical experience 
 
ExclusionCriteria 
Details  Not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Usability of the simulation doll using a expert validated questionnaire and a interview guide.  After the completion of the questionnaire administration and interview. 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   16/07/2023 
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
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Global developmental delay refers to significant delay in two or more developmental domains in children aged 5 years or younger. Developmental domains include gross or fine motor skills, speech and language, cognition, personal-social and activities of daily living

     Generally Pediatric physiotherapy units deal with various conditions such as cerebral palsy, spina bifida, muscular dystrophies, downs syndrome and spinal muscular atrophy. Early Physiotherapy interventions such as neuro developmental techniques  and balance traning, targetting gross motor developmental milestones significantly improves the motor ability of these children.

      Parents are the primary and most enduring teachers of their children. Parent education is founded on the assumption that educating parents with new information will lower their anxiety. It encourages positive changes in parental attitudes and behaviour. Parent education and training includes directly training individual parents in behavioural procedures, teaching parents in groups, and using written manuals with limited direct consultation

 Simulator training helps participants enhance their abilities in the real world. Through simulation-based learning, learners may practise clinical situations and activities. It results in increased self-efficacy in the physical therapy care of paediatric patients. Previously, there was a dearth of knowledge of simulation techniques; however, with current medical developments, simulated education has gained popularity

      Physiotherapists use simulator dolls to demonstrate and train intervention   techniques. Currently two dolls are available on the digital platform. First one is a New-born baby model’ constructed of PVC. This does not present with moveable wrist and ankle joints. Second one is ’NDT Doll’ made of muslin fabric material This is unable to retain the position of its joints. Thus, the ttherapists do not have anatomically resembling dolls with realistic human joints. This poses difficulty in accurately demonstrating the exercises.

Hence,the aim of our study is to design, develop and check the usability of simulation doll for pediatrics therapy

 

 

 
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