| CTRI Number |
CTRI/2025/08/093486 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
single arm pre and post |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study looks at how effective regular physiotherapy is for children after video-assisted thoracic surgery by comparing their condition before and after the treatment. |
|
Scientific Title of Study
|
Effectiveness of conventional physiotherapy intervention in children undergoing video-assisted thoracic surgery – a single-arm pre-post 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 |
VISHAL L |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY SATTUR DHARWAD |
| Address |
SDM College of Medical Sciences and Hospital SDM University, paediatric Physiotherapy department, 1st floor, old building , OPD no 13 SDM college of physiotherapy sattur, Dharwad
SDM College of Medical Science And Hospital SDM University Paediatric Physiotherapy, Manjushree Nagar, Sattur, Dharwad
Dharwad
KARNATAKA
580023
India |
| Phone |
9148991554 |
| Fax |
|
| Email |
vishal17dubbu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VISHAL L |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY SATTUR DHARWAD |
| Address |
SDM College of Physiotherapy, Manjushree Nagar, Sattur, Dharwad
SDM College of Physiotherapy, Manjushree Nagar, Sattur, Dharwad
Dharwad
KARNATAKA
580023
India |
| Phone |
9148991554 |
| Fax |
|
| Email |
vishal17dubbu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SANJAY TEJRAJ PARMAR |
| Designation |
PROFESSOR AND PRINCIPAL |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY SATTUR |
| Address |
SDM College of Medical Science and Hospital SDM university paediatric physiotherapy department,1st floor,old building opd no 13 SDM college of Physiotherapy SDM University Sattur Dharwad
SDM College of Medical Science and Hospital SDM university paediatric physiotherapy department,1st floor,old building opd no 13 SDM college of Physiotherapy SDM University Sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9845340450 |
| Fax |
|
| Email |
sanjaytparmar777@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VISHALL |
| Address |
SDM College of Physiotherapy, Manjushree Nagar, Sattur, Dharwad |
| Type of Sponsor |
Private 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 VISHAL L |
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
PAEDIATRIC PHYSIOTHERAPY OPD NO 13,OLD BUILDING,SATTUR,DHARWAD,KARNATAKA
Dharwad
KARNATAKA |
9148991554
vishal17dubbu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children of either gender male or female
Children in the age group of 4-16 years
Children who have an ICD placed prior to planning for VATS
Children diagnosed with any lung conditions who are planned for vats surgery
• Children diagnosed with empyema thoracic and planned for VATS by a medical
practitioner
• Children after post VATS surgery |
|
| ExclusionCriteria |
| Details |
Children who are not willing
• Children who are medically unstable
• Children who are managed conservatively
• Children who are in severe pai |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Face pain Scale
Chest X-ray
Cobb’s angle
PFT |
Baseline
Post-Op
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nill |
nill |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
this study aims to evaluate effectiveness of conventional physiotherapy in children undergoing VATS surgery the study include children aged four to sixten years participants will receive conventional physiotherapy pre and post surgery task will tailored based on patients progression therapy will be conducted for 30 to 40 minutes per session outcome measures such as face pain scale,chest xray cobs angle PFT 6min walk test will be taken before discharge and after one month the study will seek to improve posture respiratory parameter |