| CTRI Number |
CTRI/2024/08/072497 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
To compare the effect of Post Isometric Relaxation Technique and Foam Rolling Technique to improve Calf Muscle Flexibility among Young individuals |
|
Scientific Title of Study
|
Post Isometric Relaxation Technique Versus Foam Rolling Technique to improve Calf Muscle Flexibility among Young 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 |
Vanika Upadhyay |
| Designation |
BPT Undergraduate Student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Room no. 510, Department of Physiotherapy, Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8218744526 |
| Fax |
|
| Email |
upadhyayvanika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arushi Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan |
| Address |
Room no. 510, Department of Physiotherapy, Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8219368147 |
| Fax |
|
| Email |
arushimishra799@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deeksha Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan |
| Address |
Room no. 510, Department of Physiotherapy, Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8146966176 |
| Fax |
|
| Email |
deeksha0075sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital Department of Physiotherapy Kumarhatti Solan, India
Pin code 173229 |
|
|
Primary Sponsor
|
| Name |
Vanika Upadhyay |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ARUSHI MISHRA |
MAHARISHI MARKANDESHWAR MEDICAL COLLEGE AND HOSPITAL KUMARHATTI SOLAN |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arushi Mishra |
Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan |
Room no. 510, Department of Physiotherapy, Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan
Solan
HIMACHAL PRADESH |
8219368147
arushimishra799@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal Ethics Committee Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
CALF MUSCLE TIGHTNESS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foam Rolling Technique along with Hot Fomentation |
For Hot Fomentation subject will be in prone lying position and Hot Fomentation will be given for 20 minutes over the calf muscle. Foam Rolling Technique will be performed on calf muscle. Subject will be in long sitting position and the subject will be asked to use their own body weight with the help of their arms and unaffected leg. And ask subject to place his Affected leg Over the foam roller to do a to and fro motion . A total of 2 sets in which 1 set consist 30 repetition duration of the treatment will be thrice a week for 2 weeks. |
| Intervention |
Post Isometric Relaxation Technique along with Hot Fomentation |
For Hot Fomentation subject will be in prone lying position Hot Fomentation will be given for 20 minutes over calf muscle. Post Isometric Relaxation Technique will be performed on on calf muscle. Subject will be in supine lying position. A total of 2 sets in which 1 set consist of 3 repetition duration of the treatment will be thrice a week for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female with the calf muscle tightness
Age group between 18 years to 30 years
Subject with Weight bearing lunge test less than equals to 11 Centimeter |
|
| ExclusionCriteria |
| Details |
History of Trauma and fracture of lower limbs
History of neurological Conditions
Paresthesia in lower limb
Subject with hip and knee prosthesis
Subject using medication that affects the measurement (example muscle relaxants)
Musculoskeletal conditions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight bearing lunge test |
Two point measurements (on day 1 and day 14) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lower extremity functional scale |
Two point measurements (on day 1 & day 14) |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/09/2024 |
| 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
|
Calf flexibility is a essential component as its tightness is one of the common problems in young people which can lead to injury and restricted range of motion of ankle joint. Factors that contribute in reduced flexibility of calf muscle are sedentary lifestyle, medical comorbidities, inadequate stretching and prolong standing hours. Reduced flexibility and restricted range of motion can further result in reduced functional mobility. In present study a total of 126 participants will be divided into 2 groups. At baseline all participants will be assessed by weight bearing lunge test and lower extremity functional scale. Group A will receive Post Isometric Relaxation Technique and Group B will receive Foam Rolling Technique for thrice a week for 2 weeks and post intervention measurement will be taken at day 14 and data will be analyzed and result will be obtained. |