| CTRI Number |
CTRI/2024/06/068604 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study on growth status of children with cerebral palsy. |
|
Scientific Title of Study
|
Growth status in children with cerebral palsy: An observational 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 |
Dr Sakshi Gawande |
| Designation |
Junior Resident |
| Affiliation |
All India institute of physical medicine and rehabilitation |
| Address |
Physical medicine and rehabilitation outpatient department, Ground Floor, B Wing, All India Institute Of Rehabilitation, Haji Ali, Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
8788331517 |
| Fax |
|
| Email |
sakshiagawande5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Goyal |
| Designation |
Professor |
| Affiliation |
All India institute of physical medicine and rehabilitation |
| Address |
Physical medicine and rehabilitation outpatient department, Ground Floor, B Wing, All India Institute Of Rehabilitation, Haji Ali, Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
|
| Fax |
|
| Email |
vinaygoyal80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Gawande |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Rehabilitation |
| Address |
Physical medicine and rehabilitation outpatient department, Ground Floor, B Wing, All India Institute Of Rehabilitation, Haji Ali, Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
8788331517 |
| Fax |
|
| Email |
sakshiagawande5@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Physical Medicine and Rehabilitation, Haji Ali, K. Khadye Marg,Mahalaxmi,Mumbai, Maharashtra,India - 400034 |
|
|
Primary Sponsor
|
| Name |
Dr Sakshi Gawande |
| Address |
423, B wing, AIIPR, Haji ali, Mumbai - 400034 |
| 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 |
| Dr Sakshi Gawande |
All India institute of physical medicine and rehabilitation |
Physical medicine and rehabilitation outpatient department, Ground Floor, B Wing, All India Institute Of Rehabilitation, Haji Ali, Mumbai
Mumbai
MAHARASHTRA |
8788331517
sakshiagawande5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with cerebral palsy |
|
| ExclusionCriteria |
| Details |
1.Child with progressive neurological condition or neuroregression.
2. Associated major illnesses
3. Additional diagnosis of genetic disorder or spinal deformities.
4.Chilren on medications known to affect growth or body composition
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anthropometric measurements. Correlations with standard growth charts. |
single assessment at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| functional status based on GMFCS and EDACS |
single-time descriptive data. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/06/2024 |
| 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 observational study will help us determine the growth status of children with cerebral palsy using anthropometric data. it will be a single-time, cross-sectional study . it will be beneficial in providing insightful treatment for these children. |