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CTRI Number  CTRI/2024/07/070648 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between Time taken to respond to change in environment and fine movements in hand in elderly 
Scientific Title of Study   Correlation of Reaction time and Hand dexterity in elderly 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saraswati Iyer 
Designation  Professor and HOD 
Affiliation  P.T School and centre, Seth GSMC and KEM Hospital 
Address  P.T School and centre, Seth GS Medical College and KEM Hospital, Acharya Dhonde Marg, Parel(E), Mumbai-12 Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  9sarasiyer@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saraswati Iyer 
Designation  Professor and HOD 
Affiliation  P.T School and centre, Seth GSMC and KEM Hospital 
Address  P.T School and centre, Seth GS Medical College and KEM Hospital, Acharya Dhonde Marg, Parel(E), Mumbai-12 Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  9sarasiyer@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vibha Dhoot 
Designation  Master of Physiotherapy 
Affiliation  P.T School and centre, Seth GSMC and KEM Hospital 
Address  P.T School and centre, Seth GS Medical College and KEM Hospital, Acharya Dhonde Marg, Parel(E), Mumbai-12 Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  dhootvibha@gmail.com  
 
Source of Monetary or Material Support  
P.T School and Centre, Seth GS Medical College and KEM Hospital, Parel(E), Mumbai-12 
 
Primary Sponsor  
Name  Saraswati Iyer 
Address  P.T School and Centre, Seth GS Medical College and KEM Hospital, Parel(E), Mumbai-12 
Type of Sponsor  Other [Self] 
 
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 Saraswati Iyer  P.T School and centre, Seth GS Medical College and KEM Hospita  KEM Hospital, Acharya Dhonde Marg, Parel(E), Mumbai-12 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
02224143435

9sarasiyer@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Seth GS Medical College and KEM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  60-80years of normal elderly people  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Age 60-80 years, coming to the OPD as relatives of the patients who are getting treated in physiotherapy OPD
2.Both Males and Females
3.Community dwelling- people who live on their
own as opposed to those taken care of in nursing homes
4.Comprehends English, Hindi or Marathi
5.Montreal Cognitive Assessment Scale score more than 25
6.Geriatric Depression Scale score less than 9
 
 
ExclusionCriteria 
Details  1. Symptomatic Musculoskeletal, Neurological or Cardiovascular conditions.
2. Uncorrected visual impairments.
3. Uncontrolled Diabetes Mellitus or Hypertension
4. Use of any psychotropic drugs
5. Pain in upper extremities VAS score more than 4
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Deary Liewald Reaction Time Task  20 times 
 
Secondary Outcome  
Outcome  TimePoints 
Nine Hole Peg Test  once 
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) 26/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 26/08/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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  

Ageing has a major consequence on cognitive and motor function. There is inevitable and irreversible neuron loss, delayed muscle activation and recruitment, reaction time prolongs and neural conduction velocity decreases. Reaction Time is defined as the interval of time between the presentation of the stimulus and appearance of appropriate voluntary response in the subject. With ageing, there is decline in attention, stimulus perception and discrimination and response selection and generation too. As a result of slowing of motor cortex and nerve conduction velocities, there is an increase in latency in Reaction time. Manual dexterity is ability to make coordinated hand and finger movement to grasp and manipulate objects. It is a fine motor skill. With ageing, Accuracy in force control tasks is reduced, isolated finger movements are decline, Variability in finger movements are augmented and motor slowing are observed. Reaction time is also required for adequate balance and postural control. In elderly, the risk of fall is high and on losing balance. Elderly use compensatory approach of grasping objects around, or manipulate objects in the hand to bring back body within stability. If the dexterity is affected, such strategies can’t be used to their full capacity. To assess reaction time, we will be using Deary Liewald Reaction Time Task on a laptop screen, and to assess dexterity nine hole peg test will be used. In this study we aim to find the correlation of reaction time and hand dexterity in elderly. 51 subjects in the population group of 60-80 years, who fulfil the inclusion criteria, will be included in this study. These participants will be assessed for reaction time and hand dexterity. The data collected will be analysed according to the distribution of data using Pearson’s Correlation test or Spearman’s Correlation test.

 

 
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