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CTRI Number  CTRI/2026/01/101919 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association of vestibulo-ocular reflex and prefrontal cortex connectivity with motor skills and functional performance in children with cerebral palsy: A cross- sectional study  
Scientific Title of Study   Correlation of Vestibulo-ocular reflex and Pre-frontal cortex connectivity with Motor skills and Functional performance in children with Cerebral palsy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Denesa Nagpal 
Designation  MPT student 
Affiliation  Amity Institute of Health Allied Sciences 
Address  Department of Physiotherapy Amity institute of Health Allied Sciences Amity University sector 125 Noida Uttar Pradesh India 201313

New Delhi
DELHI
110052
India 
Phone  7011922967  
Fax    
Email  denesa2001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priya Chauhan 
Designation  Assistant Professor II 
Affiliation  Amity institute of Health Allied Sciences , Amity University , Noida 
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University Sector125 Noida Utter Pradesh India 201313

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  7042122863  
Fax    
Email  isicpriyachauhan1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priya Chauhan  
Designation  Assistant Professor-II 
Affiliation  Amity Institute of Health Allied Sciences, Amity University , Noida 
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University Sector125 Noida Utter Pradesh India 201313

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  7042122863  
Fax    
Email  isicpriyachauhan1@gmail.com  
 
Source of Monetary or Material Support  
Akshaya Pratisthan, Church Road, Shanti Kunj, B Block, Pocket-3, Sector D, Vasant Kunj, New Delhi – 110070, India  
 
Primary Sponsor  
Name  Amity University Noida 
Address  Department of Physiotherapy Amity institute of Health Allied Sciences Amity University sector 125 Noida Uttar Pradesh India 201313 
Type of Sponsor  Private medical college 
 
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 
Dr Diksha Mago PT  Akshya Pratisthan   Physiotherapy Department, Pediatric Rehabilitation Division Second Floor, Physiotherapy Treatment Room Church Road, Shanti Kunj, B-Block, Pocket-3, Sector-D, Vasant Kunj, New Delhi, Delhi – 110070, India
South West
DELHI 
9871016289

akshayprati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional NTCC committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (2) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL. This is an observational cross-sectional study with no therapeutic, experimental, or comparator intervention.  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children aged 5 to 12 years with a confirmed diagnosis of Diplegic and Hemiplegic cerebral palsy by a pediatrician.

Level of Sitting Scale score greater than 4 indicating the child can sit with minimal support.

Children with Cerebral palsy who could understand the task to fix a picture on a wall.

Children with cerebral palsy classified within Gross Motor Function Classification System Levels I to III.

Written informed consent obtained from parents or legal guardians.

The guardian of the child must be able to read either Hindi or English to provide informed consent by signing the consent form.
 
 
ExclusionCriteria 
Details  Children diagnosed with ataxic or dyskinetic sub types of Cerebral palsy.

Severe spasticity or bone deformities that would hinder participation or task execution.

Children who are classified above the level III of Gross Motor Function Classification System are not included in the study

Presence of frontal cortical lesions as these may directly affect prefrontal function.

Manual Ability Classification System levels IV handles a limited selection of easily managed objects in adapted situations and V does not handle objects and has severely limited ability to perform simple actions.

Arm weakness due to neurological conditions such as brachial plexus injuries. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation of vestibulo-ocular reflex function and prefrontal cortex connectivity with motor skills and functional performance in children with cerebral palsy.  Single time point cross sectional assessment 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of prefrontal cortex connectivity with motor skills and functional performance in children with cerebral palsy and typically developing children.  Single time point cross sectional assessment 
Correlation of vestibulo ocular reflex function with motor skills and functional performance in children with cerebral palsy and typically developing children.  Single time point cross sectional assessment 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   06/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/02/2026 
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 observational cross- sectional study is carried out in children aged 5 to 12 years with cerebral palsy and typically developing children. The study includes two groups consisting of children with spastic diplegic and hemiplegic cerebral palsy n - 26 and age matched typically developing children n -26 who serve as the comparator group. The study is non- interventional, and no therapeutic or experimental procedures are provided to any participant.

Following informed consent from parents children meeting the inclusion criteria are enrolled in the study and undergo assessment at a single time point. Prefrontal cortex connectivity is assessed using electroencephalography during resting state recording. Vestibulo - ocular reflex function is assessed using electrooculography in combination with a gyroscope to record eye movements and head motion during controlled horizontal and vertical head movement tasks.

Motor skills are assessed using the Gross Motor Function Measure 66 and functional performance is assessed using the Pediatric Evaluation of Disability Inventory. Correlation analysis is performed between prefrontal cortex connectivity and motor skills and functional performance scales, and another correlation is made between vestibulo- ocular reflex function and motor skills and functional performance scales within each group. The correlation findings obtained from both groups are then compared. All assessments are non-invasive and completed in a single session.

It is hypothesized that vestibulo- ocular reflex function and prefrontal cortex connectivity are significantly correlated with motor skills and functional performance in children with cerebral palsy.
 
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