| CTRI Number |
CTRI/2026/01/101606 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
“Exercises That Help Older People Think Clearly and Move Safely” |
|
Scientific Title of Study
|
Effectiveness of BARAN Cognitive Rehabilitation Program on Executive Function and Balance among Institutionalized Geriatric Population |
| Trial Acronym |
BARAN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suriya V Yeldo |
| Designation |
Post Graduate student |
| Affiliation |
Medical Trust Institute of Medical sciences |
| Address |
Medical Trust Institute of Medical sciences
HOC township backside road, Irumpanam
Ernakulam KERALA 682309 India |
| Phone |
7025259735 |
| Fax |
|
| Email |
suryavyeldo@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Jerin K Issac |
| Designation |
Assistant Professor |
| Affiliation |
Medical Trust Institute of Medical sciences |
| Address |
Medical Trust Institute of Medical sciences
HOC township backside road, Irumpanam
Ernakulam KERALA 682309 India |
| Phone |
7025946717 |
| Fax |
|
| Email |
mercyissac0@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Anila Paul |
| Designation |
Professor |
| Affiliation |
Medical Trust Institute of Medical sciences |
| Address |
Medical Trust Institute of Medical sciences
HOC township backside road, Irumpanam
Ernakulam KERALA 682309 India |
| Phone |
04842843502 |
| Fax |
|
| Email |
mtimsbpt@medicaltrust.in |
|
|
Source of Monetary or Material Support
|
| Medical Trust institute of medical sciences,Irumpanam
HOC Township, Makaliyam Kavaraparambu Rd, BMC Nagar Colony, Irumpanam,
Near Kochi, Ernakulam, Kerala 682309, India |
|
|
Primary Sponsor
|
| Name |
Medical Trust institute of medical sciences |
| Address |
HOC Township, Makaliyam Kavaraparambu Rd, BMC Nagar Colony, Irumpanam,
Near Kochi, Ernakulam, Kerala 682309, India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Jerin K Issac |
St Joseph Asylum |
Holy Family Carmelite convent Kothamangalm Ernakulam 686613 Ernakulam KERALA |
7025259735
suryavyeldo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics comittee |
Approved |
| NOC from St Joseph Asylum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R418||Other symptoms and signs involvingcognitive functions and awareness, (2) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, (3) ICD-10 Condition: R54||Age-related physical debility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BARAN exercise |
Dual task exercise
3 times per week,for 4 weeks |
| Comparator Agent |
Normal daily activities |
Activities usually done in daily life (1 month) |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Ambulate without any assistive devices
Berg Balance scale less than or equal to 52
Mild to moderate cognitive impairment in MoCA
Able to understand and obey cammands |
|
| ExclusionCriteria |
| Details |
Any psychiatric disorder
Cardiovascular disorders
Neurological disorders like PD,TBI,MS
Recent fracture or injury
Visual or hearing impaired
Uncooperative individuals |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance scale
Trail making test |
Baseline, after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
01/02/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Older adults commonly experience impairments in cognition and balance. Despite this, current evidence indicates that limited research has focused on interventions specifically targeting institutionalized geriatric population. Traditional dual-task training typically employs a constant task load, which may not adequately address individual variability. In contrast, the Balance-Based Attentive Rehabilitation of Attention Network (BARAN) adopts a progressive and individualized approach by systematically adapting both balance and cognitive challenges according to the participant’s capacity. Therefore, the present study aims to investigate the effect of the BARAN cognitive rehabilitation program on executive function and balance among the institutionalized geriatric population. |