| CTRI Number |
CTRI/2024/10/074908 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Normal Value Of Nerve Conduction Velocity Of Upper And Lower Limb In Healthy Young Adult Population |
|
Scientific Title of Study
|
Reference Value of Nerve Conduction Parameters of the Upper and Lower Extremities in the Healthy Young Adult Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhumika Kashyap |
| Designation |
PG Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room Number5, Neurological Lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8219349027 |
| Fax |
|
| Email |
kashyap2001bhumika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhasish Chatterjee |
| Designation |
Associate Professor |
| Affiliation |
MMIPR |
| Address |
Neurological Lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
8708660994 |
| Fax |
|
| Email |
subhasishphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhumika Kashyap |
| Designation |
PG Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room Number5, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8219349027 |
| Fax |
|
| Email |
kashyap2001bhumika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neurological Lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, 133203 |
|
|
Primary Sponsor
|
| Name |
Bhumika Kashyap |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana |
| 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 Subhashish Chatterjee |
Maharishi Markandeshwar Super Speciality Hospital, Ambala |
Room Number 5, Neurological Lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, 133207
Ambala
HARYANA |
8708660994
subhasishphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committiee, MMIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Motor function of nerve |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy young adult population |
|
| ExclusionCriteria |
| Details |
1. People suffering from neuropathies.
2. People having musculoskeletal trauma.
3. Systemic or neuromuscular disease.
4. Any other comorbidities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Latency, Duration, Amplitude, Conduction velocity |
One time Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
21/10/2024 |
| 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="8"
Days="10" |
|
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 - NO
|
|
Brief Summary
|
Participants who are willing to participate and suitable according to inclusion criteria will be recruited for the study. The motor nerve conduction parameters of the median, ulnar, radial, common peroneal and tibial nerve will be recorded of the recruited individuals. The data collected will then be utilized to check the reference values in the healthy young adult population. |