| CTRI Number |
CTRI/2020/11/029016 [Registered on: 10/11/2020] Trial Registered Prospectively |
| Last Modified On: |
11/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To see the Effect of movement therapy on premature babies can help to assess the development using general movement assessment - A pre post experimental study |
|
Scientific Title of Study
|
Effect of movement imitation therapy on preterm infants using 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 |
Nisha Shengule |
| Designation |
Pg student |
| Affiliation |
Kle institute of physiotherapy, belgaum |
| Address |
Kle institute of physiotherapy, nehru nagar , Belgaum
Kle institute’s of physiotherapy, nehru nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
7875774638 |
| Fax |
|
| Email |
nsheng3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa metgud |
| Designation |
Professor |
| Affiliation |
Kle institute of physiotherapy, belgaum |
| Address |
Kle institute of physiotherapy, nehru nagar , Belgaum
Kle institute’s of physiotherapy , Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Shengule |
| Designation |
Pg student |
| Affiliation |
Kle institute of physiotherapy, belgaum |
| Address |
Kle institute of physiotherapy, nehru nagar , Belgaum
Kle institute’s of physiotherapy, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
7875774638 |
| Fax |
|
| Email |
nsheng3@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar kore hospital and research centre, nehru nagar , Belgaum |
|
|
Primary Sponsor
|
| Name |
Kle Institute of physiotherapy |
| Address |
Kle institute of physiotherapy, nehru nagar , Belgaum |
| Type of Sponsor |
Private 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 |
| Nisha shengule |
Dr Prabhakar kore hospital and charitable trust |
KLEU campus, Nehru Nagar, Belgaum
Belgaum
KARNATAKA |
7875774638
nsheng3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLEU Institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P09||Abnormal findings on neonatal screening, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Movement imitation therapy |
Therapy includes, simultaneous extension followed by simultaneous relaxation of the limbs and transformed to smooth and fluent movements by therapist. Imitate the orofacial gestures of tongue protrusion, mouth opening, and lip pursing. The therapist will gently guide the infant limbs by imitating the normal general movement sequence pattern. Therapy will be given for 4-5 times/ day for 10-20 min . |
| Comparator Agent |
Movement imitation therapy |
Therapy includes, simultaneous extension followed by simultaneous relaxation of the limbs and transformed to smooth and fluent movements by therapist. Imitate the orofacial gestures of tongue protrusion, mouth opening, and lip pursing. The therapist will gently guide the infant limbs by imitating the normal general movement sequence pattern. Therapy will be given for 4-5 times/ day for 10-20 min. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
➢ Infants born to preterm were included.
➢ Infants with cramped synchronised and poor repertoire general movement |
|
| ExclusionCriteria |
| Details |
➢ 1. Infants on mechanical ventilation
➢ 2.infants with congenital heart anomaly |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Prechtl’s General movement assessment tool |
General movement assessment method of qualitative assessment of general movements of infants spontaneous repertoire from birth upto 6 month of age . General movement assessment is a good predictor of the diagnosis of neurological disorder |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcome |
No secondary outcome |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
11/11/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Preterm infants are more prone for developmental problems compared to term infant. Therefore we want to see if your infant has any problems with development and if it is there, then any change in them after giving intervention of movement imitation therapy using general movement assessment. Therefore we want to conduct a study which may help in your infant early identification of developmental problems with the help of early intervention therapy. This will prevent the future complications associated with it. |