| CTRI Number |
CTRI/2026/03/105300 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Doing Two Tasks at Once on Physical Ability and Balance in Older Adults Living at Home |
Scientific Title of Study
Modification(s)
|
Effect of dual task on physical performance and balance in community dwelling geriatrics |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YATRI MEHUL PARIKH |
| Designation |
1st year Post Graduate student |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
PG 1 Classroom 2nd floor, Department of Neurological and psychosomatic disorders, College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya, Taluka Waghodia, Vadodara, Gujarat, India 391760
Vadodara GUJARAT 391760 India |
| Phone |
6353227248 |
| Fax |
|
| Email |
yatrimp811@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nensi Gandhi |
| Designation |
Assisstant Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
Staffroom First floor, Department of Neurology, College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya, Taluka Waghodia, Vadodara, Gujarat, India 391760
Vadodara GUJARAT 391760 India |
| Phone |
9913577382 |
| Fax |
|
| Email |
drnensi.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Nensi Gandhi |
| Designation |
Assisstant Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
Staffroom First floor, Department of Neurology, College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya, Taluka Waghodia, Vadodara, Gujarat, India 391760
Vadodara GUJARAT 391760 India |
| Phone |
9913577382 |
| Fax |
|
| Email |
drnensi.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| The study will be conducted in different residential societies located in Vadodara, Gujarat, India. As the societies are situated in different areas with different pincodes, the location has been mentioned collectively. |
|
|
Primary Sponsor
|
| Name |
YATRI MEHUL PARIKH |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Wagidia, Vadodara,391760 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Yatri Parikh |
Mukti Nagar |
Mukti Nagar, Near Basil School, Tandalja, Vadodara, Gujarat, India,390020 Vadodara GUJARAT |
6353227248
yatrimp811@gmail.com |
| Yatri Parikh |
Rajendrapark Society |
Rajendrapark Society, near arvind society, New Sama Road, Vadodara, Gujarat, India 390024 Vadodara GUJARAT |
6353227248
yatrimp811@gmail.com |
| Yatri Parikh |
Shantipark Society |
Shantipark society, behind KakaNiBhaajiPav, Karelibaug,Vadodara, Gujarat, India, 390016 Vadodara GUJARAT |
6353227248
yatrimp811@gmail.com |
| Yatri Parikh |
Sharad Nagar |
Sharad Nagar Society, Tarsali, Vadodara, Gujarat, India,390009 Vadodara GUJARAT |
6353227248
yatrimp811@gmail.com |
| Yatri Parikh |
Suncity Paradise |
Suncity Pardise, behind vishwamitri township opposite gujarat tractor, Manjalpur, Vadodara, Gujarat, India 390012 Vadodara GUJARAT |
6353227248
yatrimp811@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY GERIATRIC POPULATION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age: Adults aged 65 years and above.
Older adults who live at home or with their families, and not in nursing homes or other
care facilities.
Able to walk independently with or without assistive devices.
No acute medical illness in the past 2 weeks and medically stable. |
|
| ExclusionCriteria |
| Details |
1.Severe cognitive impairment or diagnosed dementia that causes an individual inability to
understand the tests.
2.Acute illness or recent hospitalization (within the last 2 weeks) that may affect physical
performance.
3.Any musculoskeletal disorders, neurological and psychosomatic conditions or with cardiorespiratory condition.
4.Severe visual or auditory impairment not correctable with aids, interfering with test
participation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Short Physical Performance Battery (SPPB) will be used to assess physical performance
in community-dwelling geriatric individuals. Improvement in post-test scores will indicate
enhanced physical performance in community dwelling geriatrics.
|
The Short Physical Performance Battery (SPPB) will be assessed at baseline 15 minutes prior to a single dual-task training session and immediately after completion of the session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Berg Balance Scale (BBS) will be used to evaluate balance performance. An increase in
post-test scores will indicate improvement in balance in community dwelling geriatrics. |
The Berg Balance Scale will be assessed at baseline 15 minutes prior to a single dual-task training session & immediately after completion of the session. |
|
|
Target Sample Size
|
Total Sample Size="69" Sample Size from India="69"
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)
|
23/03/2026 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A cross-sectional study will be conducted among community-dwelling older adults aged 60 years and above. Participants will be selected through convenience sampling based on inclusion criteria. The study details will be explained to all participants, and written informed consent will be obtained prior to participation. Demographic data, medical history, and anthropometric measurements will be recorded.Baseline assessment of physical performance and balance will be carried out using the Short Physical Performance Battery (SPPB) and the Berg Balance Scale (BBS).Participants will then undergo a single supervised dual-task session. They will be instructed to walk 10 meters at a comfortable speed while simultaneously performing backward counting. Equal attention will be given to both walking and counting tasks. The time taken to complete the walking task will be recorded. Safety precautions will be ensured, including therapist supervision, obstacle-free walking area, and rest intervals if required.Immediately after the dual-task session, physical performance and balance will be reassessed using SPPB and BBS. Pre- and post-test scores will be recorded and compared to determine changes in physical performance and balance. |