| CTRI Number |
CTRI/2024/08/072367 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Visual function in cerebral palsy based on gross motor function |
|
Scientific Title of Study
|
Visual function of individuals with cerebral palsy under gross motor function classification system. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAMYA V |
| Designation |
PG student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of optometry, MCHP, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9150040043 |
| Fax |
|
| Email |
ramya3.mchmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Radhika |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of optometry, MCHP, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7349247069 |
| Fax |
|
| Email |
radhika.pu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Radhika |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of optometry, MCHP, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7349247069 |
| Fax |
|
| Email |
radhika.pu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| MCHP, Manipal, Karnataka- 576104, INDIA |
|
|
Primary Sponsor
|
| Name |
Ramya V |
| Address |
MCHP, Manipal, Karnataka- 576104 , INDIA |
| 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 |
| Dr Radhika |
Kasturba hospital |
Department of optometry, CTC building, 9Q3Q+FVH, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
7349247069
radhika.pu@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Cerebral palsy individual
Individuals with or without mobility device |
|
| ExclusionCriteria |
| Details |
GMFCS level 5
Patients with other associated neurological disorders like intellectual disability, seizure disorder or epilepsy, secondry condition of vision and hearing problem, delay of growth and development |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual functions of Cerebral palsy individual under each GMFCS level |
One time measurement of all the assessments. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of visual functions of individuals from each GMFCS level using data analysis software |
One time |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/08/2024 |
| 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) |
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
|
This study is crossectional observational study examines the visual functional skills of 60 patients across different levels of the Gross Motor Function Classification System (GMFCS) (except GMFCS level 5) between the age of 5-17years . The primary outcome measures will be Confrontation visual field test represented with the counting fingers at the four quadrants. Cornel reflex test for strabismus will be denoted with the degree per millimetre of deviation. Random dot stereopsis will be denoted with second of arc. Cycloplegic refraction is denoted with the power diopters. Visual acuity test will be denoted with log MAR units. Contrast sensitivity will be denoted in “%â€. Swinging flashlight test for RAPD will be graded and near pupillary response techniques will be observed. DEM test will be denoted with test ratio and time taken in vertical and horizontal card. In NSUCO the participant will be scored till 15 and will be graded accordingly. TVPS-4 includes seven scales, and each question will be graded 1. It is done by scoring the ability of perception. 11.
|