| CTRI Number |
CTRI/2025/02/080756 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [MOVEMENT IMITATION THERAPY to replicate normal General Movements] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Movement Imitation Therapy to see its effects on General Movements of
Very Preterm and Extreme Preterm Neonates |
|
Scientific Title of Study
|
Movement Imitation Therapy v/s Standard Care in
Very Preterm and Extreme Preterm Neonates: A Randomised Controlled Trial (MOTIVE trial)
|
| 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 Meghana S |
| Designation |
Senior Resident, DM Neonatology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Neonatology,
Sri Ramachandra Institute of Higher Education and Research, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9035457037 |
| Fax |
|
| Email |
s.meghana1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRAKASH AMBOIRAM |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Neonatology,
Sri Ramachandra Institute of Higher Education and Research, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9791181566 |
| Fax |
|
| Email |
draprakash1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR G TRINITY DEEPAK FRANCIS |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Neonatology,
Sri Ramachandra Institute of Higher Education and Research, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9501582108 |
| Fax |
|
| Email |
dr.gtdeepak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai, Tamil Nadu, India
600116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandre Institute of Higher Education and Research |
| Address |
Porur, Chennai
Tamil Nadu 600116 |
| 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 |
| Dr Meghana S |
Sri Ramachandra Institute of Higher Education and Research |
Department of Neonatology, C3 NICU and G block 3rd floor NICU,Sri Ramachandra medical Centre and Sri Ramachandra Hospital,
Porur, Chennai- 600116
Chennai
TAMIL NADU |
9035457037
s.meghana1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Movement Imitation Therapy |
MIT-SC group
In this group, neonates will receive standard care as well as Movement Imitation Therapy
A. Movement Imitation Therapy: The MIT will be administered under a radiant warmer or incubator in the Neonatal Intensive Care Unit, ensuring standard sound and light conditions. The therapy will be provided by trained therapists or the mother, after her training and readiness to administer MIT have been assessed using the checklist provided in Appendix 3.
The Techniques
a)The neonate’s limbs are gently guided, mimicking typical motor sequences as closely as possible.
b)The smooth and fluent movements, such as simultaneous extension and relaxation of limbs are incorporated.
c)Variability is introduced by adjusting the sequence, amplitude, and speed of movements.
d)The stressful movements are avoided to maintain the infants calmness throughout the session.
Session Duration and Frequency
a)Therapy sessions are conducted for a minimum of 10 minutes each till discharge at least for a period of 10 days.
b)At least 4 sessions per day are conducted, with regular breaks to prevent overstimulation, preferably before feeding.
B. Standard Care: early intervention program as per hospital’s developmental unit; Karthikeyan Child Developmental Unit (KCDU) which includes the following,
a)Parental Education
b)Visual Stimulation
c)Auditory Stimulation
d)Tactile stimulation
|
| Comparator Agent |
Standard Care |
In this group the neonates will receive Standard Care only; an early intervention program as per hospital’s developmental unit; Karthikeyan Child Developmental Unit (KCDU) which includes the following,
a)Parental Education
b)Visual Stimulation
c)Auditory Stimulation
d)Tactile stimulation
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Day(s) |
| Age To |
14.00 Day(s) |
| Gender |
Both |
| Details |
All pre-term neonates born between 26wks 0/7 to 31wks 6/7 weeks gestational age, admitted in Neonatal Intensive Care unit, and who are hemodynamically stable, from their second week of life. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Neonates with genetic or congenital anomalies affecting motor function.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| General Movement Optimality Score- Revised (GMOS-R) at 34 weeks Post Menstrual Age (PMA) |
At 34 weeks Post Menstrual Age (PMA) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. GMOS-R at 5 months of chronological age
2. Neurosonogram/MRI brain at term equivalent age
3. Hammersmith Neonatal Neurological Examination at term equivalent age |
At term equivalent age & at 5 months of chronological age |
|
|
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)
|
03/03/2025 |
| 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 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
|
The MOTIVE trial is a randomized controlled study comparing Movement Imitation Therapy (MIT) to standard care in very preterm and extreme preterm neonates. Conducted at Sri Ramachandra Institute of Higher Education and Research, the study aims to assess the impact of MIT on neurodevelopmental outcomes using the General Movement Optimality Score-Revised (GMOS-R) at 34 weeks post-menstrual age (PMA). The trial will involve stratified randomization of eligible preterm neonates, with MIT sessions incorporating guided limb movements mimicking normal general body movements. Secondary outcomes include GMOS-R at 5 months of corrected age, MRI/Neurosonogram findings at term-equivalent age, and the Hammersmith Neonatal Neurological Examination (HNNE) scores. The study follows ethical guidelines, ensuring informed parental consent and confidentiality, with blinded outcome assessment to minimize bias. |