| CTRI Number |
CTRI/2023/10/058980 [Registered on: 20/10/2023] Trial Registered Prospectively |
| Last Modified On: |
11/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF PROGRESSIVE BALANCE TRAINING AND DIGITAL COGNITIVE TEST BATTERY FOR BALANCE AND COGNITION AMONG YOUNG ADULTS WITH SMARTPHONE ADDICTION - RANDOMIZED CONTROLLED TRIAL |
|
Scientific Title of Study
|
EFFECT OF PROGRESSIVE BALANCE TRAINING AND DIGITAL COGNITIVE TEST BATTERY ON DYNAMIC BALANCE AND COGNITION AMONG YOUNG ADULTS WITH SMARTPHONE ADDICTION - RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kotian Sushmita Jagdish |
| Designation |
PG student |
| Affiliation |
Srinivas College of Physiotherapy |
| Address |
Neuro OPD, Institute of Physiotherapy, City Campus, Srinivas University, Pandeshwar, Mangalore, India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9920459808 |
| Fax |
|
| Email |
sushikotian98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Radhika Gopal S |
| Designation |
Assistant Professor |
| Affiliation |
Srinivas College of Physiotherapy |
| Address |
Neuro OPD, Institute of Physiotherapy,City Campus,Srinivas University,Pandeshwar,Mangalore,India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9995507379 |
| Fax |
|
| Email |
radhikaradhu1590@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kotian Sushmita Jagdish |
| Designation |
PG student |
| Affiliation |
Srinivas College of Physiotherapy |
| Address |
Neuro OPD,Institute of Physiotherapy,City Campus,Srinivas University,Pandeshwar,Mangaluru,India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9920459808 |
| Fax |
|
| Email |
sushikotian98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neuro OPD, Institute of Physiotherapy,City Campus,Srinivas University, Pandeshwar, Mangalore-575001. |
|
|
Primary Sponsor
|
| Name |
Kotian Sushmita Jagdish |
| Address |
Institute of Physiotherapy,City Campus,Srinivas University,Pandeshwar,Mangaluru,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 Kotian Sushmita Jagdish |
Srinivas University |
Neuro OPD,Institute of Physiotherapy,City Campus,Srinivas University,Pandeshwar,Mangaluru,India
Dakshina Kannada
KARNATAKA |
9920459808
sushikotian98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas University Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
People who are addicted to smartphone based on screen time i.e. using phone more than 4 hours. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Instructions to prevent Smartphone Addiction |
Instructions to prevent Smartphone Addiction through a booklet. |
| Intervention |
Progressive balance training using Bosu Ball -For dynamic balance.
Digital Cognitive test battery -For Cognition |
Progressive balance training will be given 3 times in a week for 4 weeks for 30 minutes.
Digital cognitive test for-10 minutes for 3 times a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Using the Phone for > 4 hours per day
Smartphone Addiction-Boys-31, Girls-33
Trail-making Test - Part A-29 secs
Part B- 75 secs |
|
| ExclusionCriteria |
| Details |
Subjects with Auditory, visual, or perceptual deficits.
Deformities of the lower limbs and spine
Surgical operations in the lower limbs
Deep sensory loss, history of epilepsy
History of cerebral concussions, diabetic or smoker, alcoholic
Any diseases affecting balance and neuromuscular control
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Y-balance test
Cognitive Failure Questionnaire
Trail-Making Test |
Before starting intervention
After giving intervention
Follow-up after 1 Month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 2 |
|
Date of First Enrollment (India)
|
20/10/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
EFFECT OF PROGRESSIVE BALANCE TRAINING AND DIGITAL COGNITIVE TEST BATTERY ON DYNAMIC BALANCE AND COGNITION AMONG YOUNG ADULTS WITH SMARTPHONE ADDICTION -RANDOMIZED CONTROLLED TRIAL GOT ETHICAL APPROVAL FROM SRINIVAS UNIVERSITY ETHICS COMMITTEE TO PROCEED
AS THE CAPACITY TO THINK, PAY ATTENTION IS BADLY IMPACTED BY SMARTPHONE ADDICTION AND THERE ARE NO COMBINED INTERVENTIONAL RESEARCH TO ENHANCE COGNITIVE FUNCTION AND DYNAMIC BALANCE IN YOUNG ADULTS WITH SMARTPHONE ADDICTION THEREFORE IT IS NECESSARY TO PROVIDE AN INTERVENTION THAT ENHANCES COGNITIVE FUNCTION AS WELL AS DYNAMIC BALANCE |