| CTRI Number |
CTRI/2025/09/095487 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study On Standing Balance and Memory, Attention In Older Adults |
|
Scientific Title of Study
|
Association Between Tandem Stance Test And Cognitive Function In Older Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KEERTHI S |
| Designation |
MPT POST GRADUATION STUDENT |
| Affiliation |
MS RAMAIAH COLLEGE OF PHYSIOTHERAPY |
| Address |
M S RAMAIAH NAGAR ,MSRIT POST BANGALORE
Bangalore
KARNATAKA
560054
India |
| Phone |
9353773088 |
| Fax |
|
| Email |
keerthimamatha3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MR NANDA KUMAR S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MS RAMAIAH COLLEGE OF PHYSIOTHERAPY |
| Address |
M S RAMAIAH NAGAR ,MSRIT POST BANGALORE
Bangalore
KARNATAKA
560054
India |
| Phone |
9900952657 |
| Fax |
|
| Email |
nandakumar.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
MSANAGHA B KULKARNI |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
MS RAMAIAH COLLEGE OF PHYSIOTHERAPY |
| Address |
M S RAMAIAH NAGAR ,MSRIT POST BANGALORE
Bangalore
KARNATAKA
560054
India |
| Phone |
8748884210 |
| Fax |
|
| Email |
anaghabk.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KEERTHI S |
| Address |
University House, New BEL Rd, M S R Nagar Mathikere Bengaluru Karnataka 560054 |
| 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 |
| KEERTHI S |
RAMAIAH MEDICAL COLLEGE AND HOSPITAL |
M S RAMAIAH NAGAR ,MSRIT POST BANGALORE
Bangalore
KARNATAKA |
09353773088
keerthimamatha3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAMAIAH MEDICAL COLLEGE |
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 |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
i. Age: 65 -75 YEARS(young older adults)- WHO
ii. Able to stand and walk for at least 3 meters independently
iii. Ability to read and write English and Kannada |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
i. Severe cognitive impairment (less than or equal to 10)-MoCA
ii. Diagnosed with peripheral neuropathy
iii. Neurological conditions-Affecting gait and balance
iv. Visual or auditory impairments
v. Musculoskeletal impairmentsa. Recent fractures of lower limb and spine
b. Severe pain
c. Limb length discrepancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tandem stance test And Montreal Cognitive assessment |
BASELINE ON THE DAY OF ASSESSMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
10/10/2025 |
| 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="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
|
The study will be submitted to the Institutional Ethics Committee of Ramaiah Medical College for approval and clearance,The study will be explained to the participants in Kannada or English,
Screening of voluntarily interested participants based on inclusion and exclusion criteria.Recruitment of eligible participants by obtaining informed consent and collecting demographic data.
Outcome Measures: Tandem Stance Test: To assess balance MoCA (Montreal Cognitive Assessment): To assess cognitive function
Duration maintained in Tandem Stance will be timed and recorded. MoCA scores will be documented
|