| CTRI Number |
CTRI/2023/11/059904 [Registered on: 16/11/2023] Trial Registered Prospectively |
| Last Modified On: |
15/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Establish Normative data of Upper Extremity Reaction Time using an innovative self- made Reaction Time device amongst elderly women in age group 55-65 years- An Observational study |
|
Scientific Title of Study
|
Normative data of Upper Extremity Reaction Time using an innovative self- made Reaction Time device amongst Elderly women in age group 55-65 years- An Observational 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 |
Dr. shrikant Darade |
| Designation |
Associate Professor |
| Affiliation |
Motiwala college of Physiotherapy |
| Address |
Motiwala college of Physiotherapy, Motiwala nagar, via Ashok Nagar, satpur- Gangapur road Nashik
Nashik
MAHARASHTRA
422012
India |
| Phone |
9422600245 |
| Fax |
|
| Email |
daradeshri31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shantha Kumar |
| Designation |
PhD guide and Professor |
| Affiliation |
Professor College of Physiotherapy, Lovely Professional University |
| Address |
Department of Physiotherapy,Physiotherapy OPD, Block number 3, room 301, lovely Professional University, Jalandhar, Punjab
Jalandhar
PUNJAB
144001
India |
| Phone |
9422600245 |
| Fax |
|
| Email |
shanthadhaniya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shwetanjali Bhagra |
| Designation |
PhD scholar |
| Affiliation |
PhD scholar, Lovely professional University |
| Address |
College of Physiotherapy, Lovely Professional University, Department of Ortho-Physiotherapy, Block number 03, room number 201, Jalandhar, Punjab
Jalandhar
PUNJAB
144001
India |
| Phone |
9422600245 |
| Fax |
|
| Email |
shwetanjali.gandhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Motiwala college of Physiotherapy, Motiwala Nagar, Satpur, Satpur Colony, Nashik, Maharashtra 422222, India |
|
|
Primary Sponsor
|
| Name |
Dr Shwetanjali Bhagra |
| Address |
College of Physiotherapy, Lovely Professional University, Department of Ortho-Physiotherapy, Block number 03, room number 201, Jalandhar, Punjab |
| 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 shwetanjali Bhagra |
Motiwala Hospital and College of Physiotherapy |
Motiwala College of Physiotherapy, 3rd Floor, Department of Musculoskeletal Physiotherapy
Nashik
MAHARASHTRA |
09422600245
shwetanjali.gandhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Motiwala Physiotherapy college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
elderly patients with no |MSK/CVS/Neurological involvement |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
395 subjects from a tertiary care hospital, all females of the age 55–65 years, who were non-alcoholic, non-diabetic, had near-to-corrected normal vision and hearing acuity with no evidence of CNS disease, and had a perfect sense of physical and mental well-being, were recruited in the study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.establishing normative data for Reaction time using self made reaction time tool |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reaction time in elderly women & its co-relation with falls |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="395"
Sample Size from India="395"
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)
|
30/11/2023 |
| 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 Yet Recruiting |
| 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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shwetanjali.gandhe@gmail.com].
- For how long will this data be available start date provided 13-06-2023 and end date provided 13-12-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The association between reaction time and aging is
undeniable. But there are very few studies that have been able to identify
normative values using choice reaction time on a simple and effective device
setup.
We will try to establish the normative values of
reaction time using the self-made reaction time tool. The tool is an effective
replacement for complicated software and minimizes artefacts. The tool will also
used in the lateral aspect, which is often not recorded yet is an important
entity in the diagnosis and training of falls. We will trying to find a correlation
between increasing age and reaction time for both the anterior and lateral
aspects. |