| CTRI Number |
CTRI/2025/04/085785 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Trunk Control, Oral Motor Skills, Breathing, and Functioning effect on Children with Cerebral Palsy. |
|
Scientific Title of Study
|
Relationship between Trunk control, Oromotor function, Respiratory function and Functional level in 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 |
Sweta Pandit |
| Designation |
Postgraduate |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Neurosciences, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna,Nagpur 441110, Maharashtra, India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9322122651 |
| Fax |
|
| Email |
swetapandit1612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ira Indurkar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Neurosciences, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna,Nagpur 441110, Maharashtra, India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8806449657 |
| Fax |
|
| Email |
physioira@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sweta Pandit |
| Designation |
Postgraduate |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Neurosciences, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna,Nagpur 441110, Maharashtra, India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9322122651 |
| Fax |
|
| Email |
swetapandit1612@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe College of Physiotherapy,Wanadongri Hingna Road Nagpur MAHARASHTRA India 441110 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy |
| Address |
Wanadongri, Hingna Road,Nagpur 441110, MAHARASHTRA, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sweta Pandit |
Datta Meghe College of Physiotherapy |
Neurosciences OPD , Datta Meghe College of Physiotherapy, Wanadongri , Hingna Road Nagpur 441110, Maharashtra , India
Nagpur
MAHARASHTRA |
9322122651
swetapandit1612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved, Physiotherapy, Nursing (APN) Colleges Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
children from 5 to 12 years
cooperative enough to understand the test directions
At levels I II and III according to GMFCS |
|
| ExclusionCriteria |
| Details |
At level IV V according to GMFCS
congenital malformations accompanying CP
Visual and hearing impairments that would prevent evaluations
severe convulsions that cannot be controlled with drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
segmental Assessment of Trunk Control
Oromotor assessment scale
Pulmonary Function Test
Gross Motor Classification System
|
1 Baseline (week 0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
10/05/2025 |
| 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="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
|
Ethical
committee clearance will be taken from the institutional committee. Screening of participants will be done using inclusion and exclusion criteria. The subject’s guardian/parents and children will be given written informed
consent in the best language understood by them. Trunk control will be assessed by Segmental Assessment Trunk Control, Oromotor
function will be assessed by Oromotor
Assessment Scale, Functional level will be assessed by Gross Motor
Classification System, and Respiratory function will be assessed by PFT spirometry and respiratory assessment. The data collected will be statistically analyzed to check if there is any
correlation between Trunk control, Oromotor function, Respiratory function, and
Functional level in Children with CP. The correlations will be compared in
Children from 5 years to 12 years, Cooperative enough to understand the
test directions, At levels I, II, and III according to GMFCS. The study will be conducted under supervision. Hence, the conclusion will be drawn accordingly. |