| CTRI Number |
CTRI/2022/12/048114 [Registered on: 14/12/2022] Trial Registered Prospectively |
| Last Modified On: |
11/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [visual therapy] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of visual therapy in children with cerebral visual impairment |
|
Scientific Title of Study
|
Rehabilitative effectiveness of visuo-stimulation, visuo-motor and visuo-perceptual learning interventions in improving neuro-visuo-cognitive behaviour in children with CVI compared to standard care: A randomised control pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Chaurasia |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
121, Advanced Eye Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9990909575 |
| Fax |
|
| Email |
shwets84omns@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Chaurasia |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
121, Advanced Eye Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9990909575 |
| Fax |
|
| Email |
shwets84omns@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhara Sardhara |
| Designation |
student |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Advanced Eye Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7567736516 |
| Fax |
|
| Email |
dhara.sardhara9898@gmail.com |
|
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Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh, India |
|
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Primary Sponsor
|
| Name |
No sponsor |
| Address |
NA |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Shweta Chaurasia |
Post Graduatye Institute of Medical Education and Research, Chandigarh |
Room no 121, Dept of Ophthalmology, Advanced Eye Centre, PGIMER, Sector 12
Chandigarh
CHANDIGARH |
01722756111
shweta84omns@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P039||Newborn affected by complication of labor and delivery, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control |
standard therapy which will include pediatric and ophthalmological evaluation and management of childs systemic conditions, dispensing spectacles (if indicated) |
| Intervention |
Visual Therapy (visual stimulation, visuomotor and visuoperceptual learning interventions) |
Intervention- a structured training
Various visual stimulation exercises will be explained at baseline and every follow up; additionally, educational videos will be shared for other caregivers at home not visiting
It will be dividd into three parts:
1) Building visual behabiour like visual attention (VS) excercise using bright colour simple toys without simple array, using tactile stimulation, movement,light in decluttered environment and opto-type presented one at a time multiple times in a day coherent with attention span of child simple target one at a time, also passive checkerboard or sine wave grating pattern or alternating checker board pattern with odd ball stimuli
2) Building and integrating attention with visual function (visual motor and visual perception) (VS + VML + initiate basic VPL exercise) using visual communication, follow, fixation, reaching out, hand eye coordination, visual search, visual recognition.
3) Further Building and refining VML + VPL and build cognition like expanding items of visual recognition, facial recognition, copying, figure ground, form constancy, short term visual memory, tasks in visual clutter, task involving distance vision, visual memory, tasks requiring planning.
Frequency and dose of advised visual exercises: 10-15 minutes every waking hour of child preferably total of 3-4 hours/day
Duration of intervention: 1 year |
|
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Inclusion Criteria
|
| Age From |
0.50 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria includes
1. patients with history and documentation of perinatal asphyxia, periventricular leukomalacia, hypoglycemia, perinatal infections, genetic, metabolic, hydrocephalus, or structural causes or
2. documented perinatal brain damage confirmed by a pediatric neurologist along with
3. MRI evidence of brain injury in a pattern typical of hypoxic-ischemic encephalopathy (HIE) including peri-ventricular leukomalacia (PVL)
4. problems in visual functioning (corroborated by results of functional vision assessment) or atypical neuro-visuo-behavior or visual perceptual or cognitive dysfunction on CVI inventory questionnaire and
5. confirmed on examination with at least 2 or more of the following: a) Deficit or impaired visual inattention, fixation, or inability to follow objects; b)Deficit visual guided reach or visual guidance of upper limbs (inability to reach out or hold a toy or difficulty in picking up a toy); c) Deficit visual communication/search/curiosity/ spatial orientation; d)Deficit visual processing like recognition of face/objects/facial expression or Difficulty with clutter
|
|
| ExclusionCriteria |
| Details |
• Children with pediatric cataracts, corneal pathologies, retinal pathologies, or dense amblyopia responsible for low vision
• Retinopathy of prematurity of grade 4 or 5, and major ROP sequelae like falciform fold involving disc or macula nonresolving macular bleed, vitreous hemorrhage assessed by a paediatric ophthalmologist
• Children with epileptic spasms, electroclinical epileptic encephalopathy, seizure frequency of more than one/month in the past 3 months or patients using anti-epileptic vigabatrin
• Children with debilitating illnesses requiring immediate attention
• Children whose caregivers refuse to participate in the study
• Autistic children
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome is improvement in FUNCTIONAL VISION in terms of
1. improvement in visual acuity,
2. visual attention (attention span, reaction time and number of orienting responses),
3. achieving steadiness of visual fixation,
4. improvement in visual communication,
5. improvement in visual guidance of limbs or visuomotor tasks
6. improvement in visual perception including cognition, recognition
|
outcome will be assessed at the end of 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Imaging findings and correlation of imaging findings with clinical findings
• pre and post electrophysiologic findings (Improvement in P100 latency)
findings and correlation of imaging findings with clinical findings |
at end of 1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/12/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to study rehabilitative effectiveness of vision therapy in improving visual attention, visuo-perceptual, visuo-motor and visuo-cogntive behaviour in children with cerebral visual impairment by conducting a randomised controversy study where patients will be divided into two arms: one arm shall receive standard therapy and other would receive vision therapy apart from standard management. Vision therapy will include home based tailored visual stimulation, visuo-motor, visuo-perceptual and cognitive tasks depending on child’s functional vision. Children with suspected CVI will be observed and proforma will be filled up with regard to their neuro-visual behaviours, characteristic findings, visual grade, oculomotility pattern, electrophysiological tests, fundus findings, imaging findings etc. All children will undergo detailed paediatric neurological evaluation. Imaging will be analysed by radiologists and scored. The rationale of the study is that home-based visual stimulation and rehabilitative strategies (tailored to the CVI inventory responses and examination findings) if explained to carers and carefully applied, can improve visual skills and neuro-visual behavior in children with cerebral visual impairment, thereby improving everyday visual functioning, participation, and quality of life as an ultimate goal. |