CTRI Number |
CTRI/2018/06/014448 [Registered on: 07/06/2018] Trial Registered Prospectively |
Last Modified On: |
06/06/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Do vision and balance in children with cerebral palsy relate with each other? |
Scientific Title of Study
|
Correlation between visual impairments and functional balance in children with cerebral palsy. |
Trial Acronym |
VCS,ECAB,PBS,CP |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mrs Archana Gore |
Designation |
Assistant Professor |
Affiliation |
Physiotherapy School and Center, seth GSMC & KEM hospital |
Address |
402, Physiotherapy school and center, Opp TATA hospital, eBorges road, Parel 12
Mumbai (Suburban) MAHARASHTRA 400012 India |
Phone |
9223256919 |
Fax |
|
Email |
nilarch17@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Mrs Archana Gore |
Designation |
Assistant Professor |
Affiliation |
Physiotherapy School and Center, seth GSMC & KEM hospital |
Address |
402, Physiotherapy school and center, Opp TATA hospital, eBorges road, Parel 12 402, Physiotherapy school and center, Opp TATA hospital, eBorges road, Parel 12 Mumbai (Suburban) MAHARASHTRA 400012 India |
Phone |
9223256919 |
Fax |
|
Email |
nilarch17@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Ms Charmi Parmar |
Designation |
MPTh student |
Affiliation |
Physiotherapy School and Center, seth GSMC & KEM hospital |
Address |
402, Physiotherapy school and center, Opp TATA hospital, eBorges road, Parel 12 402, Physiotherapy school and center, Opp TATA hospital, eBorges road, Parel 12 Mumbai (Suburban) MAHARASHTRA 400012 India |
Phone |
9223256919 |
Fax |
|
Email |
parmarcharmi@yahoo.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
DJST |
Address |
Seth GSM college & KEM hospital |
Type of Sponsor |
Research institution and hospital |
|
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 |
Mrs Archana Gore |
PT department,KEMH |
Pediatric neurorehabilitation section, Room number 5,ground floor, 402 Mumbai (Suburban) MAHARASHTRA |
9223256919
nilarch17@yahoo.co.in |
|
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 |
Children with crebral palsy, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
1.50 Year(s) |
Age To |
10.00 Year(s) |
Gender |
Both |
Details |
Children with ante-natal, peri-natal and post-natal events of neurological damage. |
|
ExclusionCriteria |
Details |
Uncontrolled epilepsy.
b) Auditory loss or impairment.
c) Severe tightness and deformity.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1) To find correlation between Pediatric Balance Scale(PBS) with Visual Classification Scale (VCS). |
1 week |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) To find correlation between Pediatric Balance Scale(PBS) with Visual acuity, refraction, binocular vision and ocular motility |
3 months |
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
10/11/2018 |
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="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Background: A typically
developing child has an overall feedback from somatosensory, visual, auditory
and vestibular systems which affects development of physical and emotional
growth. Although the normal visual system is not mature at birth and needs much
of the first 6months to become useful, enough visual stimuli reach the
developing brain to make vision a motivator for bonding and head control. A child with cerebral palsy may have
impairments in any of these systems thus leading to delayed achievement of
milestones, being more or less dependent for activities of daily living on
parents and thereby lesser opportunities for overall development. A
physiotherapist treats a child with cerebral palsy with a broad goal of
improving independence and increasing quality of life both for them and their
parents.
Impaired
vision can interfere in the growth emotionally as well as physically. The first
motor milestone of head control may be delayed or unachieved. A child will be
tempted to raise, move head and body in direction of visual and auditory
stimuli. Various factors like level of spasticity, tightness, voluntary
control, cognition can affect motor development along with vision. The motor
recruitment, firing, strength of muscle contraction will impair balance and
posture development. The correlation between visual deficits
and functional balance can help early identification and correction to help
achievement of milestones .Hence the need for the study is to correlate
visual impairment and balance scales PBS
& ECAB and GMFCS.
Aim: To find the
correlation between visual impairments and functional balance in children with
cerebral palsy.
Objectives: To find correlation of PBS, ECAB and GMFCS
1)
With VCS
2)
With Visual
Acuity
3)
With Refraction
4)
With
Binocular Vision and Ocular Motility
Methodology :
An observational
study will done in children with cerebral palsy
of 1.5 – 10 years of age, who will be screened for inclusion and
exclusion criteria selected through convenient sampling between November
2018 – August 2019 in the physiotherapy department of a tertiary hospital. A
detailed explanation of the purpose and the procedure of the study will be
given to the parents of eligible
children and will be requested to participate in the study by signing the
Inform Consent Document. Also, wherever
applicable, for children above 7 years of age - the child’s assent will be
taken separately after the study procedure has been explained. Physiotherapeutic assessments
will be performed including scales for balance assessments like PBS & ECAB
and GMFCS on all the children in the
physiotherapy department of a tertiary hospital. These children will undergo
routine ophthalmologic examination carried out by the ophthalmology department
within the same tertiary hospital which includes tests for visual functions and
a visual classification scale(VCS). The VCS levels will be correlated with PBS
& ECAB and GMFCS . Also, visual acuity, refractive errors, the various components
of binocular vision and ocular motility will each be correlated with PBS &
ECAB and GMFCS .
The statistical analysis will be performed using IBM SPSS
Statistics 23. Quantitative variables like age, height, weight, range of
motion, etc. will be expressed as mean, median and standard deviation. All
quantitative data would be tested for normality using the Kolmogorov Smoimov
test or the Shapiro Wilk test. Qualitative data like gender, presence for
visual acuity, binocular single vision, ocular motility, refraction and levels
of Visual Classification Scale will be expressed as frequency and percentages.
The correlation of PBS, ECAB and GMFCS with VCS will be done
by Chi Square test. The relationship between PBS and ECAB with Visual Acuity
will be done using Pearson correlation test or Spearman’s
correlation test. The correlation of PBS with
Refraction and Binocular single vision ,ocular motility will be analyzed using
Mann-Whitney U test or Kruskal Wallis H test. The correlation of ECAB with
Refraction and Binocular single vision ,ocular motility will be done by using
Mann-Whitney U test. The relationship between GMFCS and Visual Acuity,
Refraction and Binocular single vision ,ocular motility will be analyzed using
Chi Square test. p value less than 0.05 will be considered significant. |