| CTRI Number |
CTRI/2026/02/102992 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Goal-oriented intervention for functional goal and motor skill in infant with or at risk of neuromotor dysfunction. |
|
Scientific Title of Study
|
Goal-oriented intervention for functional goal and motor skill in infant with or at risk of neuromotor dysfunction. |
| 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 |
Physiotherapist |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Advance Physiotherapy centre ,room number 39, sagar floor , KLE Dr Prabhakar Kore Hospital , Nehru Nagar, Belagavi-590010 Karnataka Belgaum KARNATAKA 590010 India |
| Phone |
09845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shravani maroor |
| Designation |
Physiotherapist |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Advance Physiotherapy centre ,room number 39, sagar floor , KLE Dr Prabhakar Kore Hospital , Nehru Nagar, Belagavi-590010
Belgaum KARNATAKA 590010 India |
| Phone |
7090407141 |
| Fax |
|
| Email |
shravani5219@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shravani |
| Designation |
Physiotherapist |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Advance Physiotherapy centre ,room number 39, sagar floor , KLE Dr Prabhakar Kore Hospital , Nehru Nagar, Belagavi-590010
Belgaum KARNATAKA 590010 India |
| Phone |
7090407141 |
| Fax |
|
| Email |
shravani5219@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar Belagavi 590010, Karnataka India
|
|
|
Primary Sponsor
|
| Name |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
KAHER INSTITUTE OF PHYSIOTHERAPY, JNMC campus ,Nehru nagar Belagavi 590010 |
| 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 |
| Shravani Maroor |
KAHER Institute Of Physiotherapy |
Advance Physiotherapy centre ,room number 39, sagar floor , KLE Dr Prabhakar Kore Hospital , Nehru Nagar, Belagavi-590010 Belgaum KARNATAKA |
7090407141
shravani5219@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Institute Of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Goal oriented Intervention |
Over a period of four weeks, caregivers will carry out daily therapy sessions at home based on the individualized goals. Therapist will conduct virtual guidance sessions(tele rehabilitation) twice a week to support and monitor progress, making any necessary adjustments along the way. |
| Comparator Agent |
post intervention comparission |
PDMS 2 and GAS outcome measures are assessed post intervention after 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
11.00 Month(s) |
| Age To |
13.00 Month(s) |
| Gender |
Both |
| Details |
• Infants of age 12 months (corrected age).
• Both males and females are included.
• Infant at risk of Neuromotor dysfunction:
Infant screened with mild , moderate and severe The Hammersmith Infant Neurological Examination (HINE) scores
Corrected Age High-Risk Cut-off Score
• Written informed consent is obtained from the parent or legal guardian prior to participation.
|
|
| ExclusionCriteria |
| Details |
• Infants diagnosed with visual or auditory impairments that limit their ability to follow instructions or participate in motor assessments.
• Infants who were receiving any physiotherapy intervention from past few weeks.
• Parents of participants not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PDMS-2
Goal attainment Scale |
PDMS-2
Goal attainment Scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="21" Sample Size from India="21"
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)
|
17/02/2026 |
| 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="1" Months="0" 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 investigates the effect of an individualized goal-oriented intervention on functional goals and motor skills in infants aged 12 ± 3 months who are at risk of or have neuromotor dysfunction. Neuromotor dysfunction refers to impairments in motor control, coordination, and movement resulting from disturbances in the developing nervous system. During infancy, the brain demonstrates high neural plasticity, making early identification and intervention crucial for improving motor outcomes and preventing long-term functional limitations.
The study emphasizes a goal-directed, family-centered therapy approach, where meaningful and personalized functional goals are identified collaboratively with caregivers. Functional goals are prioritized because they directly relate to daily activities and promote active participation. Infants are screened using the Hammersmith Infant Neurological Examination (HINE) to ensure accurate identification of those at risk. Motor development and progress are assessed using the Peabody Developmental Motor Scales-2 (PDMS-2), while individualized functional achievement is measured through the Goal Attainment Scale (GAS).
A pre–post quasi-experimental design will be conducted at a high-risk baby clinic in a tertiary care hospital. Twenty-one eligible infants will be recruited through consecutive sampling. After baseline GAS and PDMS-2 assessments, each infant will receive a four-week individualized goal-directed therapy program. Caregivers will perform daily home-based sessions, supported by therapist guidance through tele-rehabilitation twice weekly. The intervention follows structured steps including goal setting, task analysis, strategy planning, skill practice, feedback, and re-evaluation.
Post-intervention assessments will compare changes in motor skills and functional goal achievement. Statistical analysis will determine the effectiveness of the intervention. The study aims to demonstrate that early, structured, goal-oriented therapy combined with caregiver involvement can significantly enhance motor development and functional independence in infants at risk of neuromotor dysfunction, thereby supporting better long-term developmental outcomes. |