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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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