| CTRI Number |
CTRI/2025/12/098448 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of dual-task training on balance and mobility in visual impairment Patients - An interventional study |
|
Scientific Title of Study
|
Effect of dual-task training on balance and mobility in individuals with visual impairment - An interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranami Jitendrabhai Pandya |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy RK UNIVERSITY |
| Address |
School of Physiotherapy RK UNIVERSITY Kasturba Dham Rajkot
Bhavnagar Highway Rajkot Gujarat India School of Physiotherapy
RK UNIVERSITY Kasturba Dham Rajkot Bhavnagar Highway Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
09512868922 |
| Fax |
|
| Email |
ppandya383@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chirag Solanki PT |
| Designation |
Assistant Professor , School of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy RK UNIVERSITY |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
9714054600 |
| Fax |
|
| Email |
chirag.solanki@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Pranami Jitendrabhai Pandya |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy RK UNIVERSITY |
| Address |
School of Physiotherapy RK UNIVERSITY Kasturba Dham Rajkot
Bhavnagar Highway Rajkot Gujarat India School of Physiotherapy
RK UNIVERSITY Kasturba Dham Rajkot Bhavnagar Highway Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
09512868922 |
| Fax |
|
| Email |
ppandya383@rku.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pranami Jitendrabhai Pandya |
| Address |
School of Physiotherapy, RK UNIVERSITY, Kasturba Dham, Rajkot,Gujarat,India. 360020
Bhavnagar Highway, Rajkot Gujarat 360020 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 |
| Pranami Jitendrabhai Pandya |
Andh Kanya Chhatralay |
Andh Kanya Chhatralay, Alanknanda apartment, Javahar road, Junagadh
Junagadh
GUJARAT |
09512868922
ppandya383@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H543||Unqualified visual loss, both eyes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual task training |
The dual-task training program involves balance and mobility exercises performed simultaneously with secondary cognitive tasks. The intervention includes structured sessions targeting standing balance (narrow-base stance, tandem stance, single-leg stance, toe tapping) and functional mobility activities while performing cognitive tasks such as memory and recall tasks (recalling items from specific letters or categories), attention tasks (serial subtraction by 3s, 7s, and 9s), and working memory tasks (digit span forward and backward). Training will be delivered for 45 minutes per session, three sessions per week, for four weeks. Appropriate safety precautions will be followed throughout the sessions, with rest periods provided as needed to prevent fatigue and ensure participant comfort. |
| Comparator Agent |
Single-task / Traditional Balance Training |
Participants will perform traditional balance and mobility exercises—including narrow-base stance, tandem stance, single-leg stance, toe tapping, and functional mobility tasks—without any cognitive tasks. The training will be given for 45 minutes per session, three sessions per week for four weeks, with standard safety measures and rest periods provided. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Individuals with low vision and blindness ( more than 60% visual impairment in both the eyes)
2) Independent ambulation with or without the use of a cane
3) The lack of injury or deformity in the lumbar region, trunk, and lower limbs
4) Patients who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1) Any types of neurological disorder that can affect sensory and motor function
2) Vestibular or hearing dysfunction
3) Visual impairment for less than 3 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Timed up and go (TUG) test |
1st Day and End of 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| One leg stand (OLS) test |
1st Day and End of 4th week |
|
|
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)
|
15/12/2025 |
| 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="6"
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
|
TOPIC: Effect of Dual task training on balance and mobility in individuals with visual impairment – An Interventional Study
INVESTIGATOR: Pranami Pandya , School of Physiotherapy R K University , Rajkot
AIM: To find out the effect of dual-task training on balance and mobility in individuals with Visual impairment
OBJECTIVES : 1.To evaluate the effect of dual-task training on balance in individuals with visual impairment. 2.To evaluate the effect of dual-task training on mobility in individuals with visual impairment.
MATERIAL: Chair with arm rest, Stop watch, Measure tape, Foam pad, Cones, Velcro straps, Pen, Pencil, Paper, Assessment Form, Consent Form
PROCEDURE Subjects who fulfill the inclusion criteria will be selected. Consent will be taken from all the subjects for participating in the study. Further , selected 60 subjects will be divided into two groups Group A : Interventional group and Group B : Control group. Pre-Assessment & Post Assessment of Balance and Mobility will be checked by One leg stand (OLS) Test and Timed up and go (TUG) test. Group A (n=30) Dual task training will be given. Group B (n=30) Traditional Balance training will be given. 45 minutes of each session, 3 sessions per week for 4 weeks training program.
|