| CTRI Number |
CTRI/2013/08/003929 [Registered on: 29/08/2013] Trial Registered Prospectively |
| Last Modified On: |
26/10/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Normal value of standing balance in children and adolescent |
|
Scientific Title of Study
|
Reference value of the postural sway in children and adolescent with their relation to anthropometrics |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1146-1853 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asir John Samuel |
| Designation |
Lecturer |
| Affiliation |
Alvas college of Physiotherapy |
| Address |
Alvas college of Physiotherapy,
Moodabidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481939806 |
| Fax |
|
| Email |
asirjohnsamuel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asir John Samuel |
| Designation |
Lecturer |
| Affiliation |
|
| Address |
Alvas college of Physiotherapy,
Moodabidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481939806 |
| Fax |
|
| Email |
asirjohnsamuel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asir John Samuel |
| Designation |
Lecturer |
| Affiliation |
|
| Address |
Alvas college of Physiotherapy,
Moodabidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481939806 |
| Fax |
|
| Email |
asirjohnsamuel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences
Indian Council for Medical Research |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences |
| Address |
4th T block
Jayanagar
Bangalore |
| Type of Sponsor |
Other [University Research Grants] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ICMR |
V. Ramalingaswami Bhawan, Ansari Nagar,
P.Box No. 4911
New Delhi – 110029
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Asir John Samuel |
Institution of Alvas Education Foundation |
Mangalore main road,
Vidyagiri
Dakshina Kannada
KARNATAKA |
9481939806
asirjohnsamuel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Alvas Review Board on Ethics for Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening of their postural sway |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunters studying in schools and colleges |
|
| ExclusionCriteria |
| Details |
1. Uncooperative participants
2. Visual impairment
3. Known balance complaint |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postural sway |
1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body composition (% of body fat) |
1 |
|
|
Target Sample Size
|
Total Sample Size="8000"
Sample Size from India="8000"
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)
|
26/05/2014 |
| 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="3"
Months="1"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
Details will be provided to ICMR and be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background:
Postural sway is the important parameter in
measuring balance. In the developing country such as India, the reference value
of the postural sway is not established. The anthropometrics relation with the
postural balance was not established adequately. Objective:
To
establish the reference value of the postural sway in the age group between 8
and 25 years and thereby to find their association with the anthropometrics Research
design: Single blinded Cross-sectional study
Sampling
design: Stratified random sampling
Sample
size: 8000
Method:
Participants aged between 8 and 25 years will be recruited. The anthropometric
measures of them such as height (cm), weight (Kg), arm span (cm) and body
composition of the recruited participants will be estimated by their skin fold
thickness, Waist-to-Hip ratio (WHR), Body Mass Index (BMI) and waist
circumference in a randomized sequence. All the participants’ postural sway in
Anterolateral (AP) direction (mm/s), Mediolateral (ML) direction (mm/s) and
velocity moment (mm2/s) will be measured in the static computerized
posturography. Mean of three trials will be used for analysis. Association between
anthropometrics and postural sway will be established by Pearson/Spearman
correlation based on the normality of the collected data. |