| CTRI Number |
CTRI/2025/09/094070 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out Body Balance, Control of Posture and how children suffering from cerebral palsy do daily activities using various scales. |
|
Scientific Title of Study
|
Correlation between Posture Control, Balance and Functional Status 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 |
Dr Krishna Singh |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Room no 33, Department of PMR, Main OPD Building, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7011229536 |
| Fax |
|
| Email |
raazfojdar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Jain |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Room no 33, Department of PMR,Main OPD Building, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9999143589 |
| Fax |
|
| Email |
shweta_10775@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Singh |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Room no 33, Department of PMR, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7011229536 |
| Fax |
|
| Email |
raazfojdar@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital,Ansari Nagar East,Near AIIMS Metro Station, New Delhi, 110029 |
| Type of Sponsor |
Government 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 Krishna Singh |
VMMC and Safdarjung Hospital |
Room no 33, Department of PMR, Main OPD Building
New Delhi
DELHI |
7011229536
raazfojdar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC and Safdarjung Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G80||Cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 4 and 14 years having Diagnosis of Cerebral Palsy who can obey simple commands. |
|
| ExclusionCriteria |
| Details |
Children with visual or hearing impairment.
Difficulty to participate in assessment procedure due to Intellectual Impairment.
Associated Autism Spectrum Disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out Correlation between Posture Control, Balance and Functional Status in Children with Cerebral Palsy |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out Correlation between Posture Control with Type of Cerebral Palsy. |
At Baseline |
| To find out Correlation between Posture Control & Balance with Spasticity |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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="6"
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
|
Children with Cerebral Palsy in age group 4 to 14 years coming to the OPD in the Department of Physical Medicine and Rehabilitation Safdarjung Hospital fulfilling the Inclusion and Exclusion criteria will be included in the study after informed consent. A pre structured proforma containing demographic details and clinical assessment with various scales will be filled. |