| 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
|
|
|
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
|
|
|
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. |