| CTRI Number |
CTRI/2024/05/067460 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Examination of quadriceps strength using pressure biofeedback |
|
Scientific Title of Study
|
Evaluation of quadriceps strength using pressure biofeedback in healthy individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jay Patil |
| Designation |
MPT student |
| Affiliation |
Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9819427613 |
| Fax |
|
| Email |
jaypatil7445@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrudula Sangaonkar |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8087469330 |
| Fax |
|
| Email |
mrudula.sangaonkar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrudula Sangaonkar |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune
MAHARASHTRA
411018
India |
| Phone |
8087469330 |
| Fax |
|
| Email |
mrudula.sangaonkar@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Jay Patil |
| Musculoskeletal department, Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Jay Patil |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune |
| 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 Jay Patil |
Dr. D. Y. Patil college of Physiotherapy,Pimpri, Pune, |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune, Maharashtra
Pune
MAHARASHTRA |
9819427613
jaypatil7445@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe of Dr. D. Y. Patil college of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
young adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals between 20-40 years
willing participants |
|
| ExclusionCriteria |
| Details |
Lower limb injuries like recent fractures within last 6 months or individuals at rest for last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| strength using pressure biofeedback |
baseline at 0th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
27/05/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Aim: To check quadriceps strength in early adults using Pressure Biofeedback Unit
Objectives: 1. To collect data for normative values at 0 degree 2. To examine strength of quadriceps muscle
Need of study: Examining quadriceps strength is essential for determining muscle imbalances, evaluating lower limb function, and supporting fitness or rehabilitation initiatives. It aids in reducing injuries, enhancing sports performance, and comprehending overall knee stability. The amount of data collection in assessing and measuring strength of quadriceps muscle is minimal (using Pressure Biofeedback) in healthy individuals.
The pressure biofeedback cuff would be inflated to 40 mm and would be kept under the popliteal fossa of the individual. The individual would be asked to press on the cuff for 10 seconds 3 times with 10 seconds resting period in between. Three measurements would be taken and the maximum of the three would be considered for both Lower limbs. |