| CTRI Number |
CTRI/2026/01/102048 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| 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
|
Designing A Special Balance and Walking Training Program Combined with a dual Task for People with Visual Impairment |
|
Scientific Title of Study
|
Designing and testing a population specific dual-task training protocol for balance and mobility in individuals with visual impairment: A multiphasic exploratory 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 |
Department of kinesiotherapy and Exercise therapy Lab No. 3
Extension No. 214, School of Physiotherapy RK UNIVERSITY, Kasturba Dham, Rajkot-Bhavnagar Highway Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9512868922 |
| Fax |
|
| Email |
ppandya383@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urvi Pithwa |
| 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
Rajkot
GUJARAT
360020
India |
| Phone |
9427358330 |
| Fax |
|
| Email |
urvi.pithwa@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
Rajkot
GUJARAT
360020
India |
| Phone |
9512868922 |
| 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 |
R K Physiotherapy Rehabilitation and Research Center |
Physiotherapy Department room number 1, Opposite Meghani Rang Bhavan, 80 Feet Road, Bhaktinagar Circle, Rajkot, 360002
Rajkot
GUJARAT |
09512868922
ppandya383@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
A population-specific dual-task training protocol |
The population-specific dual-task training program involves balance and mobility exercises performed simultaneously with secondary cognitive tasks. The intervention includes structured sessions targeting standing balance (tandem stance, single-leg stance, toe tapping) and functional mobility activities (forward walking, sideways walking) 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, two sessions per week, for total duration of eight 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 |
NIL |
NIL |
|
|
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 70% 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 |
at baseline and at the End of 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| One-leg stand (OLS) test |
at baseline & at the End of 8th 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)
|
20/02/2026 |
| 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
|
TITLE: "Designing and Testing a Population-Specific Dual-Task Training Protocol for Balance and Mobility in Individuals with Visual Impairment: A Multiphasic Exploratory Study"
•AIM: To develop and test a population-specific dual-task training protocol on balance and mobility in individuals with visual impairment. •OBJECTIVES: To design a population-specific dual-task training protocol for balance and mobility in individuals with visual impairment. To test a population-specific dual-task training protocol in individuals with visual impairment on balance using the One-Leg Stand Test To test a population-specific dual-task training protocol in individuals with visual impairment on mobility using the Timed Up and Go Test.
METHODOLOGY: Type of study design: An Exploratory study Study setting: Registered NGOs, special education centers, and trusts providing services to individuals with visual impairment in Rajkot and around the districts. Study Population: Individuals with visual impairment Sampling technique: Purposive sampling Study duration: 6 Months Sample size: 60 participants
METHOD: The population-specific dual-task training program involves balance and mobility exercises performed simultaneously with secondary cognitive tasks. The intervention includes structured sessions targeting standing balance (tandem stance, single-leg stance, toe tapping) and functional mobility activities (forward walking, sideways walking) 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, two sessions per week, for eight weeks. Appropriate safety precautions will be followed throughout the sessions, with rest periods provided as needed to prevent fatigue and ensure participant comfort.
|