CTRI Number |
CTRI/2020/02/023460 [Registered on: 20/02/2020] Trial Registered Retrospectively |
Last Modified On: |
19/02/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Vision therapy for Autism |
Scientific Title of Study
|
The effect of vision therapy in children with autism spectrum disorder |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
A Valarmathi |
Designation |
Lecturer |
Affiliation |
Sri Ramachandra University |
Address |
No 15, G 3 Ganesh Flats, Pushpavathy Ammal Street, West Mambalam, Chennai. No 1, Sri Ramachandra Nagar, Porur, Chennai - 600 116 Chennai TAMIL NADU 600033 India |
Phone |
9884757760 |
Fax |
044-24765995 |
Email |
avmathi@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Kalpana Suresh |
Designation |
Professor |
Affiliation |
Kalpana Eye Care |
Address |
No 2, Boomadevi nagar, Gerugambakkam, Near Mahindra service station
Chennai TAMIL NADU 600128 India |
Phone |
9841226738 |
Fax |
|
Email |
kalpanasrao@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
A Valarmathi |
Designation |
Lecturer |
Affiliation |
Sri Ramachandra University |
Address |
No 15, G 3 Ganesh Flats, Pushpavathy Ammal Street, West Mambalam, Chennai. No 1, Sri Ramachandra Nagar, Porur, Chennai - 600 116
TAMIL NADU 600033 India |
Phone |
9884757760 |
Fax |
044-24765995 |
Email |
avmathi@gmail.com |
|
Source of Monetary or Material Support
|
India Vision Institute
Plot No 212, New No 45, Palkalai Nagar, 7th Link Road, Palavakkam, Chennai - 600041
|
Sri Ramachandra University and Research Institute,
No 1 Ramachandra Nagar, Porur, Chennai 600116 |
|
Primary Sponsor
|
Name |
India Vision Institute |
Address |
Plot No 212, New No 45, Palkalai Nagar, 7th Link Road, Palavakkam, Chennai - 600041 |
Type of Sponsor |
Other [IVI supports research, education and industry development to elevate health care] |
|
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 |
A Valarmathi |
Sri Ramachandra Medical College |
Department of ophthalmology, G-Block, Second floor, Room No 17,
No 1, Sri Ramachandra Nagar, Porur Chennai TAMIL NADU |
9884757760
avmathi@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Children with autism |
The degree of change over a period of 15 weeks in those children who did not receive this treatment or who were in the waitlist group |
Intervention |
Children with autism |
Vision therapy focused towards improving visual spatial skills, visual motor skills and visual analytical skills would be provided for a period of 15 weeks in three phases of 5 weeks each |
|
Inclusion Criteria
|
Age From |
4.00 Year(s) |
Age To |
13.00 Year(s) |
Gender |
Both |
Details |
Children diagnosed to have Autism Spectrum disorder |
|
ExclusionCriteria |
Details |
Subjects with a moderate to severe hearing loss, intellectually challenged subjects and emotionally disturbed subjects would be excluded from the study. Children residing in foster homes, or undergoing individualised education program or put to abuse or neglect will also be excluded from the study |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Other |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Developmental test of visual perceptual skills (DTVP-3) is the tool used pre and post vision therapy. Percentile improvement and improvement in age equivalence would be documented |
DTVP - 3 Assessment will be done at the end of 16th week of vision therapy. Change in percentile improvement and change in age equivalence will be noted down |
|
Secondary Outcome
|
Outcome |
TimePoints |
The parameters that would be monitored are the improvement in attention, eye contact, changes in behavior assessed using a parent questionnaire |
At the end of phase I, Phase II and Phase III |
|
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)
|
05/01/2018 |
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="4" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
No publications yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Most people confuse the concept of vision. When there is no refractive error and no significant deficit in visual acuity measurement then the sensory organ for vision is assumed to be normal. However children with ASD face many challenges like poor eye contact, lack of social interaction, altered behaviour with the kith and kin’s and finally with the society at large. Paucity in a structured autism specific diagnostic and interventional service puts a lot of stress on the families with children on the ASD, in India, and abroad Secondly looking into the various interventional therapies offered for children on the autism spectrum, most of the services are structured to handle all special children alike and the interventions are targeted to improve the proprioceptive (i.e., muscles and joints), vestibular (i.e., gravity and movement), and tactile (i.e., touch) systems as it is believed that they are the largest sensory system, most interconnected with other systems and the most utilised [Richard et al. 2008]. Global developmental therapies provided for children with autism spectrum disorder does not address specific deficiencies and difficulties and there are hardly any quantifiable feedback system designed, implemented and documented Any intervention targeting children with ASD should be aimed at achieving specific developmental, behavioural and educational goals [Thomas KC et al, 2007]. A standardised protocol that measures each and every aspect of vision and visual perceptual skills is not available in our country. Having understood the nuances behind the functioning of the eyes, meticulously determining and defining the deficit and working on specific deficits and finally integrating all the visual skills becomes the need of the hour and hardly any practitioner seems to be even aware of this concept. As literature is devoid of standardised diagnostic protocols and therapeutic interventional methods with a quantitative feedback report a Vision Integration Trial for autism needs to be developed and implemented. |