| CTRI Number |
CTRI/2026/01/100295 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to understand how children move and respond to sensation |
|
Scientific Title of Study
|
Sensory processing and motor development in preterm infants at 2 years of corrected age |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaval Reddy Ananya Reddy |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Faculty of Physiotherapy
Sri Ramachandra Institute Of Higher Education And Research
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
7337553335 |
| Fax |
|
| Email |
kavalreddyananyareddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajeswari. M |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Faculty of physiotherapy Sri Ramachandra Institute OF Higher Education And Research
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswari@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rajeswari . M |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Faculty Of Physiotherapy Sri Ramachandra Institute Of Higher Education And Research
porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswari@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kaval Reddy Ananya Reddy |
| Address |
Sri Ramachandra Institute Of Higher Education And Research
porur
chennai |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| RajeswariM |
Sri Ramachandra medical center and hospital |
Department of Karthikeyan child development unit,
SRIHER
Porur-600116
Chennai
Chennai
TAMIL NADU |
9841417473
rajeswari@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F843||Other childhood disintegrative disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
Preterm children at 2 years of corrected age
Both Gender
|
|
| ExclusionCriteria |
| Details |
Children with neurological impairments and musculoskeletal problems
Children with impaired hearing and vision
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PDMS Scale
|
0 to 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensory Profile Scale |
2 years |
|
|
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)
|
21/01/2026 |
| 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="5"
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 study aims to observe and assess motor function and sensory responses in the selected study population. The purpose of the study is to understand the existing patterns of movement abilities and sensory processing and their association with functional performance. Participants who meet the inclusion criteria will be assessed using standardized and validated assessment tools appropriate for the age group and condition. The study is observational in nature, and no intervention will be administered as part of the research. All assessments will be conducted during a single session or as per the study protocol.The data collected will help in identifying common motor and sensory characteristics within the study population. The findings of this study may contribute to better understanding of functional challenges and may assist physiotherapists in planning appropriate assessment strategies and future research.Participation in the study will be voluntary, and informed consent will be obtained prior to data collection. Confidentiality of participant information will be maintained throughout the study. |