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CTRI Number  CTRI/2025/02/081427 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effectiveness of Cognitive-Motor Dual-Task Training on Fall Prevention and Cognitive Function in Aging Populations: A Non-Randomized Comparative Study in South Bengaluru 
Scientific Title of Study   Effectiveness Of Cognitive-Motor Dual-Task Training on Fall Prevention and Cognitive Function Using Standardized Balance Exercises With and Without Verbal Cues Among Aging Populations at Selected Places in South Bengaluru-A Non-Randomized Comparative 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  MONISHA V 
Designation  PG STUDENT  
Affiliation  RV college of Physiotherapy 
Address  RV College of Physiotherapy Department of Community Health Physiotherapy Room no 108

Bangalore
KARNATAKA
560085
India 
Phone  7022382917  
Fax    
Email  monishavenkatachalam17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  AKSHATA NADGIR 
Designation  ASSISTANT PROFFESSOR 
Affiliation  RV college of physiotherapy 
Address  RV College of Physiotherapy Department of Community Health Physiotherapy Room no 108

Bangalore
KARNATAKA
560011
India 
Phone  9741115687  
Fax    
Email  akshatanadgir.rvcp@rvei.edu.in  
 
Details of Contact Person
Public Query  
Name  AKSHATA NADGIR 
Designation  ASSISTANT PROFFESSOR 
Affiliation  RV college of physiotherapy 
Address  RV College of Physiotherapy Department of Community Health Physiotherapy Room no 108


KARNATAKA
560011
India 
Phone  9741115687  
Fax    
Email  akshatanadgir.rvcp@rvei.edu.in  
 
Source of Monetary or Material Support  
RV College of Physiotherapy, No CA 2 83 3 9th Main Rd 4th T Block East 4th Block Jayanagar Bengaluru Karnataka India 560011 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Akshata Nadgir   RV college of physiotherapy  Department of Community Health Physiotherapy Room no 108
Bangalore
KARNATAKA 		 9741115687

akshatanadgir.rvcp@rvei.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RV Institute ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G939||Disorder of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  standard balance exercise  Incorporating a variety of exercises can enhance overall strength and balance. Activities such as marching in place and step up and step down help improve coordination and stability. Wall squats are excellent for building lower body strength, while lunges with a 0.5 kg dumbbell add resistance to leg workouts. Heel raises and toe raises target the calf muscles, contributing to better mobility. Sit to stand exercises, both with and without support, promote functional movement, while single leg standing challenges balance. Tandem walking, side walking, and backward walking are great for enhancing gait and stability, and obstacle walking using cones adds an element of agility training, making these practices well-rounded for fitness and rehabilitation for 3 days a week for 5 weeks. 
Comparator Agent  verbal cues  Engaging in a variety of cognitive activities can be both fun and beneficial. For instance, counting numbers from 1 to 50 and then back down from 50 to 1 helps enhance numerical skills and memory. Solving puzzles provides mental stimulation and promotes problem-solving abilities. A memory test can challenge one’s recall and retention, while practicing the pronunciation of vowels (a, e, i, o, u) supports language development. Additionally, recognizing animals and repeating their names reinforces vocabulary and memory. Matching pairs is a great way to improve concentration and cognitive skills. Mathematical calculations while walking can combine physical activity with mental exercise, making learning more dynamic. Lastly, drawing simple pictures not only encourages creativity but also aids in fine motor skill development. Together, these activities create a well-rounded approach to learning and mental agility for 3 days a week for 5 weeks. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Subjects willing to participate as volunteers and sign the written informed consent form, wherever necessary the family member/caregiver’s consent will be also been obtained. Subjects aged 60 and above with Mild Cognition Impairment on MMSE (17-23). Subjects should be able to ambulate independently or with the assistance of a cane or walker and older adults with balance impairment. Subjects with a fear of falls and newly diagnosed cases for the study are recruited. Subjects who can understand the verbal cues set for the study and follow the commands to complete the dual-task training.
 
 
ExclusionCriteria 
Details  Subjects with any Neurological (stroke) and Musculoskeletal disorder (total joint replacement)
Subjects with prior diagnoses of Psychiatric disorders (e.g., depressive disorder and schizophrenia).
Subjects with mobility limitations, such as those who are wheelchair-bound or bedridden, and a score of 41 and above on the Berg Balance Scale.
Subjects with a history of Cardiorespiratory or Cardiovascular diseases.
Subjects with uncontrolled Hypertension.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Berg Balance Scale (BBS)
Mini-Mental Scale Examination (MMSE)
 		 Baseline and after 5 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   14/03/2025 
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="0"
Months="6"
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   Effectiveness of Cognitive-Motor Dual-Task Training on Fall Prevention and Cognitive Function Using Standardized Balance Exercises with and without Verbal Cues among Aging Populations at Selected Places in South Bengaluru" is a non-randomized comparative study focused on reducing fall risk and enhancing cognitive function in older adults. It aims to assess the impact of combining cognitive and motor training through balance exercises, with or without verbal cues, on elderly individuals with mild cognitive impairment. The study highlights the growing prevalence of falls among seniors, linking cognitive decline to fall risks and emphasizing the need for dual-task interventions. Participants will undergo standardized balance training, with one group receiving verbal cues and the other without, over five weeks. The effectiveness will be measured using the Berg Balance Scale (BBS) and Mini-Mental State Examination (MMSE). The study seeks to determine whether verbal cues enhance the benefits of dual-task training, contributing to improved mobility, cognitive function, and overall well-being in aging populations 
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