| CTRI Number |
CTRI/2022/04/041631 [Registered on: 04/04/2022] Trial Registered Prospectively |
| Last Modified On: |
02/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Normal range for two Stimulations given together on different areas |
|
Scientific Title of Study
|
Normative reference Value of Double Simultaneous Stimulation in Asymptomatic young adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Sharma |
| Designation |
MPT |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9350105347 |
| Fax |
|
| Email |
pppsharma67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9350105347 |
| Fax |
|
| Email |
sharma.nidhi.physio@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Sharma |
| Designation |
MPT |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9350105347 |
| Fax |
|
| Email |
pppsharma67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
|
|
Primary Sponsor
|
| Name |
Priyanka Sharma |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala |
| 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 |
| Priyanka Sharma |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabiliatation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation,Maharishi Markandeshwar(deemed to be) University, Mullana, Ambala, Haryana
Ambala
HARYANA |
9350105347
pppsharma67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Maharishi Markandeshwar Institute of Medical Science and Research (Deemed to be University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Double Simultaneous Stimulation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Double Simulataneous Stimulation |
a) Tactile Stimulation - three times
b) Visual Stimulation - three times |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18-35 years
Asymptomatic individuals
Both male and female
Having intact sensation
Able to follow command
|
|
| ExclusionCriteria |
| Details |
Having sensory loss
Hearing loss
Visual impairment
Any dermatological impairment
Other systemic illness that preclude them to take part in study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| normative reference value of Double Simultaneous Stimulation |
The primary outcome will be measured on the first day of the assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation with Age and gender |
1 day |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
10/04/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective: The purpose of the study is to estimate the normative reference value of DSS in asymptomatic young adults so that it can be used for further clinical purpose. MATERIAL AND METHODS: A total of 125 asymptomatic individuals between 18-35 years will be recruited for the study. For examination of DSS, tactile and visual stimulation will be given and time will be documented with the help of stop watch. Mean will be calculated to estimate normative reference value for DSS. CONCLUSION: The normative reference value of double simultaneous stimulation in asymptomatic young adults will be estimated. |