| CTRI Number |
CTRI/2018/08/015299 [Registered on: 13/08/2018] Trial Registered Prospectively |
| Last Modified On: |
10/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of developmental therapy for preterm infants at 35-36 weeks gestational age |
|
Scientific Title of Study
|
Effect of Individualized Home Based Intervention Program in Preterm Infants At 35-36 Weeks Gestational Age Using Prechtl’s General Movement Assessment:-A Pre-Post Experimental Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jinali Jain |
| Designation |
MPT student |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF PEDIATRIC PHYSIOTHERAPY KAHER INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR BELGAUM 590010 KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
8879101753 |
| Fax |
|
| Email |
jainjinali471@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEEPA METGUD |
| Designation |
MPT, PhD ,HOD (DEPARTMENT OF PEDIATRIC PHYSIOTHERAPY) |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF PEDIATRIC PHYSIOTHERAPY KAHER INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR BELGAUM 590010 KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPA METGUD |
| Designation |
MPT, PhD ,HOD (DEPARTMENT OF PEDIATRIC PHYSIOTHERAPY) |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF PEDIATRIC PHYSIOTHERAPY KAHER INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR BELGAUM 590010 KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF PEDIATRIC PHYSIOTHERAPY
KAHER INSTITUTE OF PHYSIOTHERAPY
NEHRU NAGAR
BELAGAUM- 5990010 |
| 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 |
| Jinali Jain |
KLES PRABHAKAR KORE HOSPITAL |
High Risk Clinic, Child Development Centre, Room number 3A kaveri
Belgaum
KARNATAKA |
8879101753
jainjinali471@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
home based developmental intervention |
developmental therapy, sensory integrative therapy, Kangaroo mother care, facilitation techniques and positioning |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
Preterm Infants of 35-36 weeks gestational age
Infants with absent or abnormal general movements
Parents who will be willingly ready for participation
|
|
| ExclusionCriteria |
| Details |
Children with a congenital or genetic abnormality
Children with normal repertoire of movements
Children with recent surgery or a major malformation.
Children with a systemic infection.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prechtls General Movement Assessment |
every 15-20 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/08/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
i am doing a study, based on effect of individualized home based intervention program in preterm infants at 35-36 weeks gestational age using Prechtl’s General Movement Assessment. The infants will be recruited at 35-36 weeks gestational age and evaluated for general movements by means of video recording. These infants would be reevaluated at 38-40 weeks for assessing the quality of general movements. Infants exhibiting abnormal repertoire of movements would receive a home based developmental intervention program for 3 months. The intervention techniques would be demonstrated once by the therapist and the parents will be asked to demonstrate those techniques until they would understand it properly. They will then be asked to perform these techniques at home on their children and document in the booklets provided to them .Regular follow up appointments will be scheduled to keep a track of the patient’s condition through phone calls and visits. At 3 months post term, these infants will again be evaluated by Prechtl’s General Movement Assessment for noting the improvements in their condition. |