| CTRI Number |
CTRI/2024/03/064203 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
study is about comparing muscle activity of thigh (quadriceps) during knee straightening exercise using different types of resistance, such as elastic bands, weight cuffs, and quadriceps chairs, in healthy subjects |
|
Scientific Title of Study
|
Comparison of quadriceps electromyographic activation
across different modes of exercise training among 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 |
Abhishek Singh |
| Designation |
MPT STUDENT |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
2nd Floor, Musculoskeletal Lab, Department of Physiotherapy, ISIC Institute of Rehabilitation Sciences, Sector C Vasant Kunj, 110070 South West DELHI
South
DELHI
110070
India
South West
DELHI
110070
India |
| Phone |
7906598564 |
| Fax |
|
| Email |
loveabhi515@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Makhija |
| Designation |
Associate Professor |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
2nd Floor, Musculoskeletal Lab, Department of Physiotherapy, ISIC Institute of Rehabilitation Sciences, Sector C Vasant Kunj, 110070 South West DELHI
South
DELHI
110070
India
South West
DELHI
110070
India |
| Phone |
9910011816 |
| Fax |
|
| Email |
isicmusculoskeletal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meena Makhija |
| Designation |
Associate Professor |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
2nd Floor, Musculoskeletal Lab, Department of Physiotherapy, ISIC Institute of Rehabilitation Sciences, Sector C Vasant Kunj, 110070 South West DELHI
South
DELHI
110070
India
South West
DELHI
110070
India |
| Phone |
9910011816 |
| Fax |
|
| Email |
isicmusculoskeletal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of rehabilitation sciences - Indian Spinal Injuries Centre |
|
|
Primary Sponsor
|
| Name |
Dr Meena Makhija |
| Address |
2nd Floor, Musculoskeletal Lab,ISIC Institute of Rehabilitation Sciences Sector C Vasant Kunj 110070 South West DELHI
South
DELHI
110070
India |
| 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 Meena Makhija |
Indian Spinal Injuries Centre- Institute Of Rehabilitation Sciences |
2nd Floor, Musculoskeletal Lab, Department of Physiotherapy, ISIC Institute of Rehabilitation Sciences, Sector C Vasant Kunj, 110070 South West DELHI
South
DELHI
110070
India
South West
DELHI |
9910011816
isicmusculoskeletal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Spinal Injuries Centre- Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EMG (Electromyography) study
for quadriceps muscle |
Studying about the activity muscle infront of Thigh (Quadriceps)
using EMG during knee extension from 0° to 90° and back with Quadriceps chair, weights and theraband
in
healthy subjects.
Each
exercise is performed with 3
trials and 5 second hold for
each position. The study
intervention is evaluated by
comparing exercises against
each other in healthy
subjects. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Asymptomatic subjects with age ranging from 18 to 45 years.
Ability to perform full range of knee extension and 90 degree of knee flexion with quadricep chair, weights and theraband.
BMI less than 30Kg/meter square
|
|
| ExclusionCriteria |
| Details |
Any H/O trauma, surgery, deformity of lower limb and back,
Any H/O systemic or neurological conditions affecting movement,
Any H/O of cognitive deficits
Skin allergy
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Muscle Activity (EMG) during different exercises |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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="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 - NO
|
Brief Summary
Modification(s)
|
Quadriceps strength and endurance are of vital importance for normal knee joint function, so restoring normal quadriceps function after knee joint injuries is an essential component of rehabilitation. In this study the Silver theraband and its equivalent weight with which an individual can perform knee straightening exercise will be examined. We will use surface sensors to measure motion and muscle activity. Before placing the EMG sensor skin is cleaned with alcohol. The attachment of EMG sensor may involve shaving of hair around knee. These sensors (up to 3) will be attached over the thigh area using double-sided tape. Each participant will be asked to straighten the knee from knee in 90 degree bent position. And then from straightened position to 90 degree bent position with quadriceps chair, weights and elastic band. This will be repeated 3 times. And then compare the normalized EMG activity of quadriceps muscles across exercises, phases and ranges (0-30, 31-60, 61-90).Estimate the angle of peak activation across exercises, phases and muscle fibers. Material Used - Delsys surface emg, Theraband, Weight cuff, Quadriceps chair |