| CTRI Number |
CTRI/2026/02/104991 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Pilot test |
| Study Design |
Other |
|
Public Title of Study
|
Development And Pilot Testing Of A Questionaries To Asses Fear Of Fall In Elderly While Perform Two Task simultaneously |
|
Scientific Title of Study
|
Development And Pilot Testing Of A Questionnaire To Asses Fear Of Fall While Performing Dual Task In Older Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vallabhi Shah |
| Designation |
PG MPT 1st Year Student |
| Affiliation |
College of Physiotherapy,sumandeep vidyapeeth deemed to be university |
| Address |
PG1 classroom, 2nd floor, Department of Neurological & Psychosomatic Disorder, College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya, taluka Waghodia, Vadodara, Gujarat, India, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
6355083465 |
| Fax |
|
| Email |
shahvallabhi167@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGPalani kumar |
| Designation |
Dean and professor |
| Affiliation |
College of Physiotherapy, sumandeep vidyapeeth deemed to be university |
| Address |
Ground floor, Dean office, Department of Neurological & Psychosomatic Disorder, College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya, taluka Waghodia, Vadodara, Gujarat, India, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8238034454 |
| Fax |
|
| Email |
principal.physiotherapy@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrGPalani kumar |
| Designation |
Dean and professor |
| Affiliation |
College of Physiotherapy, sumandeep vidyapeeth deemed to be university |
| Address |
Ground floor, Dean office, Department of Neurological & Psychosomatic Disorder, College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya, taluka Waghodia, Vadodara, Gujarat, India, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8238034454 |
| Fax |
|
| Email |
principal.physiotherapy@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dhiraj General hospital, Sumandeep Vidyapeeth Deemed To Be University Campus, Pipariya, Waghodia , Vadodara, Gujrat 391760, India |
|
|
Primary Sponsor
|
| Name |
Vallabhi Shah |
| Address |
PG1 classroom, 2nd floor, Department of Neurological & Psychosomatic Disorders, College of Physiotherapy, Sumandeep Vidyapeeth, Pipariya taluka, Waghodia, Vadodara, Gujarat, India, 391760 |
| 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 Vallabhi shah |
Dhiraj General Hospital |
Physiotherapy department, Pipariya, taluka Waghodia, Vadodara, Gujarat, India, 391760
Vadodara
GUJARAT |
06355083465
shahvallabhi167@gmail.com |
|
|
Details of Ethics Committee
|
| 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 |
Older adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Phase I (development of questionnaire):
Professionals who have completed their postgraduate degree
Specialised experience in geriatric care.
Phase II (pilot testing):
Adults aged 60 years and above
All genders
Able to ambulate with or without walking aids
Persons who with or without any comorbidities
|
|
| ExclusionCriteria |
| Details |
Phase I (development of questionnaire):
Professionals holding only a bachelor’s degree
Lacking experience in geriatric care.
Phase II (pilot testing):
GDS 5 and above(on scale of 15-GDS15)
MMSE less than24
A neuro-muscular condition affects the balance
Recent and inherent balance problem
The patient has polypharmacy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Newly Developed Dual Task Questionaries |
At Baseline And One week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed Up And Go Test |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to develop and validate a novel questionnaire to assess the dual-task fear of falling in community-dwelling older adults through a two-phase methodological approach. Phase I involves a comprehensive literature review to identify relevant items and activities, followed by a formal content validation process. A multidisciplinary panel of 12 experts—including neurologists, physiotherapists, nurses, and psychologists with geriatric specialization—will evaluate the initial draft using a Modified Delphi Technique. This iterative process will involve 2–3 rounds of qualitative feedback and quantitative scoring on a 4-point Likert scale to calculate the Content Validity Index (CVI) and Content Validity Ratio (CVR) until a pre-defined consensus is achieved. Phase II consists of a pilot study to evaluate the feasibility, clarity, and practical application of the finalized questionnaire. Following approval from the Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC), a convenient sample of eligible older adults will be recruited after obtaining written informed consent. Participants will be screened for cognitive status using the Mini-Mental State Examination (MMSE) and psychological factors via the Geriatric Depression Scale (GDS). The primary assessment will involve the administration of the new dual-task questionnaire alongside the Timed Up and Go (TUG) test. The resulting data will be analyzed to determine the association between questionnaire scores and physical performance, ensuring the tool is scientifically robust and valid for future large-scale clinical use. |