| CTRI Number |
CTRI/2024/06/069085 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between quality of life and hand function |
|
Scientific Title of Study
|
Correlation between quality of life and hand function in children with cerebral palsy of age group 4-12 years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Gore |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
402, Physiotherapy School and centre,Seth G.S. Medical College and KEM Hospital, OC Building, E Borges Road ,Opposite Tata Hospital, Parel, Mumbai Physiotherapy School and Centre, Seth G.S Medical College and KEM Hospital, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9082621220 |
| Fax |
|
| Email |
nilarch17@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Komal Dilip Gaikwad |
| Designation |
MPT Student |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
402, Physiotherapy School and centre,Seth G.S. Medical College and KEM Hospital, OC Building, E Borges Road ,Opposite Tata Hospital, Parel, Mumbai - Mumbai MAHARASHTRA 400012 India |
| Phone |
9284659047 |
| Fax |
- |
| Email |
komalgaikwad466@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Archana Gore |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
402, Physiotherapy School and centre,Seth G.S. Medical College and KEM Hospital, OC Building, E Borges Road ,Opposite Tata Hospital, Parel, Mumbai Physiotherapy School and Centre, Seth G.S Medical College and KEM Hospital, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9082621220 |
| Fax |
|
| Email |
nilarch17@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy School and Centre, Seth G.S. Medical College and KEM Hospital, Parel East Mumbai 12 |
|
|
Primary Sponsor
|
| Name |
Physiotherapy school and Centre Seth G S Medical College and KEM Hospital |
| Address |
Physiotherapy school and Centre, Seth G. S. Medical College and
KEM Hospital, Mumbai, 400012 |
| 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 Archana Gore |
Physiotherapy Department , Pediatric OPD and Epilepsy Care Clinic of KEM Hospital |
1st floor,Physiotherapy
School and Centre,
Seth G. S. Medical
College and KEM
Hospital, OC Building,
E Borges Road,
opposite Tata Hospital,
Parel, Mumbai
Mumbai
MAHARASHTRA Mumbai MAHARASHTRA |
9082621220
nilarch17@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, Seth G.S. Medical College and KEM Hospital, Mumbai |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. The participants will be parents of children with cerebral palsy of age group 4-12 years visiting a paediatric neuro OPD, Epilepsy care clinic on Tuesday and paediatric medicine OPD on Thursday at tertiary care hospital between period of July 2024 to February 2025.
2. The parents will be able to read and understand either of these three languages English, Hindi, Marathi. |
|
| ExclusionCriteria |
| Details |
The parents who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Manual Ability Classification System |
Once at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cerebral Palsy Quality Of Life Questionnaire |
Once at baseline |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/07/2024 |
| 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="0" Months="8" 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
|
Cerebral palsy is a motor disability which is non-progressive and is caused by damage to CNS at or around birth. The CPQOL child is a condition specific QOL Questionnaire designed for children with CP. Primary Caregiver questionnaire evaluating seven domains appears to have very good reliability and validity. We are using a primary caregiver proxy report for children aged 4–12 years is parent reported version of CPQOL in this study. The Manual Ability Classification System (MACS) describes how children with cerebral Palsy (CP) use their hands to handle objects in daily activities. MACS describes five Levels .MACS can be used for children aged 4–18 years. For MACS the Interrater reliability between the parent and therapist was excellent (ICC between parents and therapists was 0.96) and Interrater reliability between therapists was excellent (ICC was 0.97). This Study is Correlation and Observational study and study duration will be 1 year. Study population will be children with CP who will visits at pediatric neuro physiotherapy opd between period of July 2024 to February 2025. This study will be conducted during routine treatment session of the child. Written consent will be explained to parents and signed by the parents, guardians of the subjects explaining purpose of the study. CPQOL hard copies will be given to the parents of cerebral palsy children , parents should answer the questionnaire and return it back to the investigator in 15-20 minutes. MACS assessment will be done in routine OPD in this therapist should observed how child with cerebral palsy use their hand to handle objects and according to that grading will be recorded .The levels are based on the children’s ability to handle objects and their need for assistance to perform manual activities. For assessment colorful, different size toys used to find out MACS score. Data will be collected and statistically analyzed. |