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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy pediatric therapists who are willing to participate in the study |
|
Intervention / Comparator Agent
|
|
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
|
|
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 |