| CTRI Number |
CTRI/2025/02/080831 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Developmental Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Training children with visual problems due to brain damage and at risk of motor delays using by integrating visual stimulation in motor activity |
|
Scientific Title of Study
|
Integrating CVI with Developmental Therapy to Facilitate Early Development in at Risk Children for Motor Disability |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilavan Thirumavalavan |
| Designation |
Developmental therapist |
| Affiliation |
Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha CDC, Department of Paediatrics,no.124, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam.
Chennai
TAMIL NADU
602105
India |
| Phone |
6369891316 |
| Fax |
|
| Email |
doctnila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anees Ahmed F M |
| Designation |
Paediatric Physiotherapist |
| Affiliation |
Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha CDC, Department of Paediatrics, no.124,Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam.
Chennai
TAMIL NADU
602105
India |
| Phone |
9043965344 |
| Fax |
|
| Email |
fmanees04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lal DV Nair |
| Designation |
HOD, Developmental Paediatrician |
| Affiliation |
Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha CDC, Department of Paediatrics, no.124,Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam.
Chennai
TAMIL NADU
602105
India |
| Phone |
7299938038 |
| Fax |
|
| Email |
drlaldv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha CDC, Department of Paediatrics, no.124,Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Kanchipuram district,TN,PIN-602105. |
|
|
Primary Sponsor
|
| Name |
Nilavan Thirumavalavan |
| Address |
Saveetha CDC, Department of Paediatrics, no.124Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Kanchipuram district, TN,PIN-601105 |
| 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 Anees Ahmed F M |
Saveetha Medical College and Hospital |
Saveetha CDC, Department of Paediatrics, no.124, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Kanchipuram District,TN,PIN-602105
Chennai
TAMIL NADU |
9043965344
fmanees04@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMCH - Scientific Review Board (SRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R620||Delayed milestone in childhood, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NILAS - Neuronal integrative linguistic auditated visual stimulation |
1. Relaxation Technique:
The child lies supine with an elevated head, hands supported, and knees cushioned for 5 minutes in a dark, quiet room.
2. Tonal Regulation:
The child lies supine as the therapist performs alternating knee movements and passive hand rolling for 1 minute, then rolls the child using hand support on a mattress or couch.
3. Interaction of sound producing objects:
Use a preferred-color rattle to capture the CVI child’s attention, noting responses like giggles. Present it at different positions near the child.
4. Visual activity:
Enhance mother-child bonding with a red dot on the mother’s forehead, engaging the child with vocal sounds.
5. Visuomotor:
Stimulate eye movements by scratching the eye corner and eyebrow. In supine, drop a rattle near the ears and above the head alternately, 15 times. In prone, use low-intensity light above and laterally. Stimulate visual muscles with the index.
6. Perception to sound producing object:
Assist the child in handling and shaking the rattle near the ear (lateral, midline, above) with both hands.
7. Light and sound:
Light and sound are essential in this therapy. Low-intensity light reduces irritation, while rattle sounds and parent voices enhance attention. Start with black-and-white cards, then progress to colored light tracking, using contrast-colored sound objects near ear level, based on BERA results.
8. Distance adjustment;
In the light and sound technique, adjust the visible distance based on eye reactions and CVI severity. Shake the rattle when the eye reaches the corner, waiting 5-10 seconds for a response, with the sound object near the ear.
9. Rest and reflection;
The child rests on the mothers lap for 3 minutes before being positioned in a half-lying posture facing a mirror. A light is used to aid focus, and after its removal, the parent encourages the child to maintain eye contact with the mirror.
10. Musical Instrument Play:
Musical instruments help the child hear, enjoy, and differentiate pleasant sounds, encouraging interest and prompting the child to turn and search for the sound source. |
| Comparator Agent |
Single arm study |
NOT APPLICABLE as this is a single-arm study(non randomized) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
children who were high risk newborn, with or with out damage to area other tan visual cortex. |
|
| ExclusionCriteria |
| Details |
Children who are having congenital cataract, total damage to optic nerve, total retinal detachment or vitreous humor hemorrhage or any posterior capsule damage, hydrocephalus affecting the occipital lobe. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Age and Stage Questionnaire |
Baseline and 2nd Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Gross motor Functional measure(GMFM) |
Baseline and 2nd Week |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
This study, titled "Integrating Cortical Visual Impairment with Developmental Therapy to Facilitate Early Development in At-Risk Children for Motor Disability", aims to improve visual and motor functions in children aged 0–2 years with Cortical Visual Impairment (CVI). Using the innovative NILAS (Neuronal Integrative Linguistic Auditory Visual Stimulation) approach, the study integrates visual, auditory, and tactile stimuli to address CVI symptoms such as color preference, visual latency, and difficulties with visual novelty. Conducted as a pilot study at Saveetha Medical College and Hospital, the intervention involves 2 weeks of 1 hour 15 minutes sessions in a dark room, focusing on activities such as relaxation, tonal regulation, visuomotor training, and light-sound therapy. The primary outcome is developmental progress measured using the Ages and Stages Questionnaire (ASQ), while the secondary outcome evaluates motor skills using the Gross Motor Function Measure (GMFM-88). Statistical analysis employs SPSS, with descriptive and inferential methods used to assess outcomes. Parents of participants provide informed consent, and data privacy is ensured through de-identification. By combining sensory stimulation with developmental therapy, the study seeks to enhance early motor and visual development in children with CVI. |