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CTRI Number  CTRI/2026/01/102185 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 27/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Other (Specify) [PHASE 1 is Observational study PHASE 2 is Interventional study]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Impact of Brain Gym® Program on Postural Control in Frail Old Community- Dwelling Adults 
Scientific Title of Study   Effect of Brain Gym® Program on Postural Control,Functional independence and Quality of Life in Community dwelling frail geriatric population: A mixed method 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  Heta Baxi 
Designation  PhD scholar  
Affiliation  Parul university  
Address  Sainath Hospital (Ahmedabad Physiotherapy College) Parul University 2nd floor, Room No. 218, Department of Physiotherapy , Opposite Kabir Enclave, Bopal Ghuma Road, Ghuma , Ahmedabad - 380058

Ahmadabad
GUJARAT
380058
India 
Phone  9586808871  
Fax    
Email  hdbaxi710@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhavana Gadhavi  
Designation  Dean/Principal , Guide 
Affiliation  Parul University 
Address  Physiotherapy OPD, 1st floor, Room No.18,Parul Institute of Physiotherapy, Parul University

Vadodara
GUJARAT
391760
India 
Phone  9727729787  
Fax    
Email  bhavana.gadhavi28222@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Heta Baxi 
Designation  PhD Scholar  
Affiliation  Parul University  
Address  Sainath Hospital (Ahmedabad Physiotherapy College) Parul University 2nd floor, Room No. 218, Department of Physiotherapy , Opposite Kabir Enclave, Bopal Ghuma Road, Ghuma , Ahmedabad - 380058

Ahmadabad
GUJARAT
380058
India 
Phone  9586808871  
Fax    
Email  hdbaxi710@gmail.com  
 
Source of Monetary or Material Support  
Sainath Hospital (Ahmedabad Physiotherapy College) Parul University, Opposite Kabir Enclave, Bopal Ghuma Road, Ghuma , Ahmedabad - 380058 
 
Primary Sponsor  
Name  Parul University  
Address  Parul University Sainath Hospital, opp. Kabir Enclave, Bopal Ghuma Road, Ghuma, Ahmedabad- 380058 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Heta Baxi  Parul University , Ahmedabad   Parul University Sainath Hospital,Opposite Kabir enclave , Bopal Ghuma Road, Ghuma , Ahmedabad
Ahmadabad
GUJARAT 		 9586808871

hdbaxi710@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH-SAINATH HOSPITAL,AHMEDABAD(IECHR-SAINATH HOSPITAL)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Frailty  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brain Gym® Program   3DR in supine and sitting, DLR (Dennison Laterality Repatterning) in standing (For postural control) Positive points, double doodle, grounder, calf pump (For Quality of Life, Functional independence) For 6 days a week for 12 weeks.  
Comparator Agent  Multicomponent Exercises based on FIT INDIA recommendations   For 3 days a week : Flexibility related Activities 1. Shoulder and upper-arm stretch 2. Wall upper-body stretch. 3)Doorway stretch 4)calf stretch Strength exercises : 1) Wall push 2) Standing leg raise(forward, side) Agility and balance exercises: calf raises, seated sit ups, shifting side to side, zigzag walk, single leg standing Aerobic endurance : 800 meter walking – at home (3 days a week)  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  74.00 Year(s)
Gender  Both 
Details  PHASE 1
Community dwelling men and women between age 65-74 years of age, willing to participate.

Able to follow instructions and answer clearly.

PHASE 2
Geriatric population with score between 8-11 (Mild to moderate frailty) on Edmonton Frail Scale .
 
Scoring 1 on Functional performance domain of Edmonton Frail Scale i.e. time taken between 11-20 seconds to complete the test


 
 
ExclusionCriteria 
Details  PHASE 1
Diagnosed with dizziness, vertigo
Carcinoma
Neurological conditions including diagnosed neuropathies, Parkinsonism, stroke
Recent history of any type of surgery or injury including fall within last 3 months
Visual or hearing impairment
Severe cardiovascular event within last 3 months
Institutionalized adults
Patients with severe musculoskeletal pain
Uncontrolled BP i.e. more than 140 mm Hg and 90 mm Hg
Uncontrolled Diabetes i.e. HbA1c more than 8 according to ICMR guidelines 2018
Diabetic neuropathy including ulcers tested by Ipswitch touch test

PHASE 2

Participants involved in fitness activities

Scoring 0 i.e. Normal or 2 i.e. Severe impairment. which means time taken less than 10 seconds or more than 20 seconds on Functional performance of Edmonton Frail scale

Participants excluded in PHASE 1 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
PHASE 2 (Intervention)
Postural Control using Plantar pressure system OHM 3000  		 PHASE 2 - Baseline, 6 weeks and 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Phase 2 
Date of First Enrollment (India)   20/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/02/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [hdbaxi710@gmail.com].

  6. For how long will this data be available start date provided 26-01-2026 and end date provided 26-01-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Frailty is an aging syndrome in which there is loss of harmonic interaction between genetic, biological, functional, cognitive, psychological and socio-economic domains that result in impaired postural control, obesity, frequent hospitalizations, falls, disabilities in daily living,  poor quality of life, increased healthcare utilization, and higher mortality. Frailty maybe  reversible through targeted interventions. Currently few studies have assessed frailty prevalence on a large scale. Though there are many exercise interventions which improve the quality of life and functional independence , the specific exercise improving functional independence remain unclear. Few studies have exercise interventions addressing multiple components of postural control. Brain Gym® Program is hypothesized to improve sensorimotor coordination, improve balance, stress response by specific patterns of body movements which can stimulate the corollary functions of the brain as well as the vestibular system. Although research has shown positive effect of  Brain Gym® Program  in improving cognition, balance, muscle power which are also affected in  frailty, so far effect of Brain Gym® Program  has been scarcely explored in frail  population and the quality of evidence is low. Hence, the questions which arise are  1 What is the current prevalence of frailty  2 Is  Brain Gym® Program effective in frailty ? . Hence this study aims to find an answer to the questions by a mixed method study  in which Phase 1 aims to find the prevalence of frailty in geriatric population and Phase 2 is a randomized control trial in which the experimental group shall receive Brain Gym® Program  and the Control group shall receive multicomponent exercises and effectiveness of Brain Gym® Program versus conventional exercise shall be analyzed. 
  
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