| 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
|
|
|
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
|
|
|
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. |