| CTRI Number |
CTRI/2025/08/092634 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of vestibular (eye exercise and balance) training on coordination and learning in children with developmental dyslexia |
|
Scientific Title of Study
|
Effectiveness of Vestibular Training in Develepmental Dyslexic Children—An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramesh Natrayan |
| Designation |
Professor |
| Affiliation |
YMT College of Physiotherapy |
| Address |
YMT College of Physiotherapy, sector 4, Kharghar, Navi Mumbai
Raigarh MAHARASHTRA 410210 India |
| Phone |
7874856011 |
| Fax |
|
| Email |
natraam@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ramesh Natrayan |
| Designation |
Professor |
| Affiliation |
YMT College of Physiotherapy |
| Address |
YMT College of Physiotherapy, sector 4, Kharghar, Navi Mumbai
MAHARASHTRA 410210 India |
| Phone |
7874856011 |
| Fax |
|
| Email |
natraam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ramesh Natrayan |
| Designation |
Professor |
| Affiliation |
YMT College of Physiotherapy |
| Address |
YMT College of Physiotherapy, sector 4, Kharghar, Navi Mumbai
MAHARASHTRA 410210 India |
| Phone |
7874856011 |
| Fax |
|
| Email |
natraam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ramesh Natrayan |
| Address |
5/703 Balaji Prangan CHS Sector 4, Kharghar Navi Mumbai - 410210 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Ezhilmathi PT |
YMT College of Physiotherapy |
NeuroPhysiotherapy OPD, Sector 4, Kharghar, Navi Mumbai 410210 Raigarh MAHARASHTRA |
9920302664
ezhilmathi48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Venus enus Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Developmental Dyslexia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Regular School teaching |
Regular school teaching
6 weeks |
| Intervention |
Vestibular Training |
Vestibular based Gaze stabilization Exercises.
Balance exercises
6 weeks intervention |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children with CLDQ score more than 2
Children age group between 8 years to 12 years
Children who is studying in English medium
Both genders will be included.
Parents who are willing to allow the children to participate in the study will be selected.
|
|
| ExclusionCriteria |
| Details |
Children who suffering from neurological or psychiatric abnormalities
Children who are suffering from visual impairment or difficulty with near vision
Children suffering from known vestibular disorder.
Recent history of upper limb fracture / surgery.
Children suffering from any cardiorespiratory conditions
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visuomotor Coordination and visual memory |
post-test taken after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reading speed |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
18/08/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Proposal directed to PI email id
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dyslexia is a common learning difficulty that does not compromise oral or nonverbal reasoning skills. In the literature, different theories have tried to explain the etiology of this disorder. Phonological impairment is the most well-known hypothesis for dyslexia; however, other researchers have suggested that dyslexia could be due to cerebellar impairments. A visual attentional deficit and an abnormal oculomotor pattern are present in children with dyslexia. Based on these different theories, several researchers have tried to develop different training types to improve the reading abilities of children with dyslexia. However, there has been a lack of treatment interventions specifically targeting sensorimotor training to enhance functional outcomes in children with developmental dyslexia. The vestibular system plays a crucial role in the development of visuomotor integration, memory, and cognitive processes in humans. This study evaluates the vestibular training to improve the visuo-motor and visual memory in developmental dyslexic children. |