| CTRI Number |
CTRI/2024/07/070321 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dual task performance of healthy and visually challenged individuals of age 18 to 25 years: A Comparative study |
|
Scientific Title of Study
|
Dual Task Performance of Healthy and Visually Challenged Individuals of Age 18 to 25 years-A Comparison using n-back Test (NBT) combined with Posturography and 10 Meter Walk Test (10MWT) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Atiya Shaikh |
| Designation |
Professor |
| Affiliation |
D. E. S. Brijlal Jindal College of Physiotherapy |
| Address |
Neurophysiotherapy Department Ground Floor, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus,
Shivajinagar,Pune.
Pune
MAHARASHTRA
411004
India |
| Phone |
9822860736 |
| Fax |
|
| Email |
atiya.shaikh@despune.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Aishwarya Shah (PT) |
| Designation |
Postgraduate Student |
| Affiliation |
D. E. S. Brijlal Jindal College of Physiotherapy |
| Address |
Neurophysiotherapy Department Ground Floor, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus,
Shivajinagar,Pune.
Pune
MAHARASHTRA
411004
India |
| Phone |
8788977052 |
| Fax |
|
| Email |
draishwaryashah02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Shah (PT) |
| Designation |
Postgraduate Student |
| Affiliation |
D. E. S. Brijlal Jindal College of Physiotherapy |
| Address |
Neurophysiotherapy Department Ground Floor, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus,
Shivajinagar,Pune.
Pune
MAHARASHTRA
411004
India |
| Phone |
8788977052 |
| Fax |
|
| Email |
draishwaryashah02@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.E.S Brijlal Jindal College of Physiotherapy,Fergusson College Campus, Shivajinagar, Pune, Maharashtra, India, 411004 |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Shah PT |
| Address |
Neurophysiotherapy Department,D.E.S.B.J.College of physiotherapy,Fergusson college campus,Shivajinagar,Pune, Maharashtra,India
PIN Code -411004 |
| Type of Sponsor |
Other [Self-funded ] |
|
|
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 Aishwarya Shah PT |
D. E. S. Brijlal Jindal College of Physiotherapy |
Physiotherapy OPD, Gate no 2,Fergusson college campus,Near the Amphi Auditorium,FC Road, Shivajinagar, Pune.
Pune
MAHARASHTRA |
8788977052
draishwaryashah02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| D. E. Societys BRIJLL JINDAL COLLEGE OF PHYSIOTHERAPY INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H547||Unspecified visual loss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Group A :
1.Healthy individuals of 18 to 25 years of age.
2.Healthy individuals with visual impairment of 18 to 25 years of age.
3.Both male and female participants.
4.Individuals willing to participate in the study
Group B :
1.Individuals with visual impairment of 18 to 25 years of age.
2.Visually challenged individuals with established visual loss certified by chief medical officer (CMO) (60-100%)
3.Visually challenged young adults with a score of 18 or higher on the MOCA – BLIND Scale.
4.oth male and female participants.
5.Individuals willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Individuals with known Neuromuscular, musculoskeletal and cognitive impairment that can affect motor control and postural stability.
2.Individuals with hearing deficits. 3.Individuals participating in physical sports. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Balance Master (Posturography) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 10 Meter Walk Test |
Baseline |
| n-back Test |
Baseline |
| Montreal Cognitive Assessment (MOCA) |
Baseline |
| Montreal Cognitive Assessment BLIND (MOCA-BLIND) |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2024 |
| Date of Study Completion (India) |
07/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
07/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Will be publish later on. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Participants will be screened according to the inclusion criteria and exclusion criteria.Procedure will be explained and written consent will be taken from the participants. Audio recording of the informed consent form will be used to take consent from visually challenged individuals.Participants will be categorized into two groups Group A will have healthy individuals and Group B will have visually challenged individuals. Participants will be assessed for dual task performance i.e. n Back Test (NBT) with Posturography and n Back Test (NBT) with 10 Meter Walk Test (10MWT). Comparison of static and dynamic dual task performance between Group A and Group B will be done. A prior practice for each task will be given, all the instructions will be similar for all the participants. Participants will be assessed firstly for single task and then for dual task Sequence of static and dynamic task will be decided using chit method. Participant’s performance during dual task will be recorded. Cognitive responses of participant will be recorded on a recorder for future calculation, to find out accuracy of responses. After taking this, dual task cost will be calculated, and then statistical analysis will be done. |