| CTRI Number |
CTRI/2026/04/107636 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Feasibility of Online Play-Based Therapy to Support Movement Development in Preterm Babies |
|
Scientific Title of Study
|
Feasibility of Virtually Guided Play-Based Therapy on Neuromotor Development in Preterm Infants |
| 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 Deepa Metgud |
| Designation |
HOD & Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, Sagar floor, KLE Dr Prabhakar kore Hospital Belagavi Karnataka 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Metgud |
| Designation |
HOD & Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, Sagar floor, KLE Dr Prabhakar kore Hospital Belagavi Karnataka 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Metgud |
| Designation |
HOD & Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, Sagar floor, KLE Dr Prabhakar kore Hospital Belagavi Karnataka 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KLE Institute of Physiotherapy, Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Deepa Metgud |
| Address |
KLE Institute of Physiotherapy, Nehru Nagar, Belagavi-590010, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Neha Patil |
KLE Institute of Physiotherapy, Nehru Nagar, Belagavi-590010, Karnataka, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepa Metgud |
KLES Dr Prabhakar Kore Hospital and MRC |
Advanced Physiotherapy center, room no 39, Sagar floor, KLE Dr Prabhakar kore Hospital Belagavi Karnataka 590010 India
Advanced Physiotherapy center, room no 39, Sagar floor, KLE Dr Prabhakar kore Hospital Belagavi Karnataka 590010 India
Belgaum
KARNATAKA |
9845861236
drdeepa_metgud@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KLEU Institute of Physiotherapy Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P07||Disorders of newborn related to short gestation and low birth weight, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Play-Based Therapy |
Play-based therapy is a structured, developmentally appropriate, parent-delivered intervention conducted through virtual guidance. The program includes caregiver education, demonstration of age-appropriate sensorimotor activities, positioning techniques, facilitation of postural control, midline orientation, reaching, grasping, tummy time, and early mobility exercises. Safety guidance, home-based activity planning, and regular monitoring with developmental feedback are also provided to enhance motor and overall developmental outcomes. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Month(s) |
| Age To |
8.00 Month(s) |
| Gender |
Both |
| Details |
1. Preterm infants born less than 37 weeks of gestation
2. Corrected age 4 months at time of enrolment
3. Primary caregiver (parent) willing to participate by providing written informed consent
4. Parent or caregiver who able to understand and communicate in the language used for instruction. (English, Hindi, Kannada, Marathi)
5. Availability of an electronic gadget with internet connectivity for virtual sessions
|
|
| ExclusionCriteria |
| Details |
1. Congenital anomalies that affect motor function
2. Diagnosed with severe neurological injury
3. Severe sensory impairments that would prevent participation in play-based therapy
4. Severe, unstable medical conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ages & Stages Questionnaire-3 |
Ages & Stages Questionnaire-3 will be assessed at baseline and at 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
20/04/2026 |
| 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="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
|
Preterm infants are at increased risk of neuromotor developmental delays due to immaturity of the central nervous system. Early intervention during infancy is crucial to promote optimal motor development. This study aims to evaluate the feasibility and preliminary effects of a virtually guided, play-based therapy program on neuromotor development in preterm infants. Parents will be guided through structured, age-appropriate sensorimotor play activities using virtual sessions. The intervention focuses on improving postural control, midline orientation, and functional movement through parent-delivered play under professional supervision. The program will be conducted over a six-week period with regular virtual guidance sessions. Neuromotor development will be assessed using standardised developmental assessment tools before and after the intervention. Feasibility outcomes such as adherence, acceptability, and practicality of virtual guidance will also be evaluated. The findings of this study will help determine whether virtually guided play-based therapy is a feasible and effective early intervention approach for preterm infants. |