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CTRI Number  CTRI/2024/07/070441 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effect of mental fatigue on dual task performance in healthy elderly individuals.  
Scientific Title of Study   Influence of cognitive fatigue on dual task performance in healthy elderly individuals.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Atiya Shaikh PT 
Designation  Professor 
Affiliation  D.E.S Brijlal Jindal College of Physiotherapy 
Address  Neurophysiotherapy Department, Ground Floor, D.E.S Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Pune

Pune
MAHARASHTRA
411004
India 
Phone  9822860736  
Fax    
Email  atiya.shaikh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mansi Tawari 
Designation  Postgraduate Student 
Affiliation  D.E.S Brijlal Jindal College of Physiotherapy 
Address  Neurophysiotherapy Department, Ground Floor, D.E.S Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Pune

Pune
MAHARASHTRA
411004
India 
Phone  9834496344  
Fax    
Email  mansitawari100@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mansi Tawari 
Designation  Postgraduate Student 
Affiliation  D.E.S Brijlal Jindal College of Physiotherapy 
Address  Neurophysiotherapy Department, Ground Floor, D.E.S Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Pune

Pune
MAHARASHTRA
411004
India 
Phone  9834496344  
Fax    
Email  mansitawari100@gmail.com  
 
Source of Monetary or Material Support  
D.E.S Brijlal Jindal College of Physiotherapy, Ferguson College Campus, Shivajinagar, Pune, Maharashtra, India 411004 
 
Primary Sponsor  
Name  Mansi Tawari 
Address  Neurophysiotherapy Department,D.E.S.B.J.College of physiotherapy,Fergusson college campus,Shivajinagar,Pune, Maharashtra,India PIN Code -411004  
Type of Sponsor  Other [Self funded] 
 
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 Mansi Tawari  DES Brijlal Jindal College of Physiotherapy., Pune  Physiotherapy OPD, Gate no 2, Fergusson college campus,Near the Amphi Auditorium,FC Road, Shivajinagar, Pune.
Pune
MAHARASHTRA 		 9834496344

mansitawari100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
D.E.Societys BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Elderly Individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1. Age group 60 years & above
2. Able to walk 3-meter distance with or without assistive device
3. Have a score of 26 or higher on the Montreal Cognitive Assessment Scale. (No
cognitive impairment)
4. Able to follow commands.
5. Able to read, understand and interpret Hindi or Marathi or English.
6. Are educationally 8th grade pass.
7. Willing to participate in the study. 
 
ExclusionCriteria 
Details  1. Uncorrected vision/ auditory impairments.
2. Presence of diagnosed neurological or psychiatric disorders affecting cognitive
function.
3. History of recent major medical events or surgeries in the last 6 months.
4. Severe sensory impairments affecting assessment participation.
5. Current use of medications known to significantly influence cognitive
performance.
6. Pain on NPRS for any body part less than 4 or any orthopaedic condition, Lower limb
fracture in last 6 months or any deformities that would affect walking ability. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Timed Up and Go Test
 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
N-Back Test  Baseline 
Montreal Cognitive Assessment (MOCA)  Baseline 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/07/2024 
Date of Study Completion (India) 12/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/03/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   1. Participants will be recruited through snowball method from community outreach and healthcare facilities. 
2. Pre-screening assessments will be conducted to ensure eligibility based on inclusion and exclusion criteria. 
3. Informed consent will be obtained from each participant.
4. Single task performance (Timed up and go test and n-back test) and dual task performance using TUG-NBT will be assessed. 1 practice trail will be given for both the tasks. 
5. Participants will undergo cognitive fatigue induction through a task.
6. While the test is being carried out, the number of their responses said out loud will be recorded. 
7. Subjective reports of cognitive fatigue will be collected through Numeric Pain Rating Scale (NPRS). 
8. Single task and Dual Task performance will be assessed after induction of fatigue. 
9. The scores will be recorded and analysis will be done using appropriate statistical methods. Dual task cost will be calculated.
 
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