| CTRI Number |
CTRI/2021/12/038449 [Registered on: 06/12/2021] Trial Registered Prospectively |
| Last Modified On: |
01/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The immediate effect of self myofascial release on the sole of foot on posterior thigh muscles flexibility in athletes: A Randomized Controlled Trial |
|
Scientific Title of Study
|
The immediate effect of self myofascial release on the plantar surface of foot on hamstring flexibility in athletes: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaidehi Dingare |
| Designation |
Post Graduate |
| Affiliation |
Sancheti Institute College Of Physiotherapy |
| Address |
Department of Sports Physiotherapy, 1st floor, Sancheti Healthcare Academy, 11/12, Thube Park, Shivajinagar, Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9373429667 |
| Fax |
|
| Email |
vaidehidingare@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Gangwal |
| Designation |
Associate Professor, Department of Sports Physiotherapy |
| Affiliation |
Sancheti Institute College Of Physiotherapy |
| Address |
Department of Sports Physiotherapy, 1st floor, Sancheti Healthcare Academy, 11/12, Thube Park, Shivajinagar, Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
7619941787 |
| Fax |
|
| Email |
sancheticop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Gangwal |
| Designation |
Associate Professor, Department of Sports Physiotherapy |
| Affiliation |
Sancheti Institute College Of Physiotherapy |
| Address |
Department of Sports Physiotherapy, 1st floor, Sancheti Healthcare Academy, 11/12, Thube Park, Shivajinagar, Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
7619941787 |
| Fax |
|
| Email |
sancheticop@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College Of Physiotherapy |
| Address |
11/12, Thube Park, Shivajinagar, Pune 411005 |
| Type of Sponsor |
Private medical college |
|
|
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 Vaidehi Dinagre |
Sancheti Hospital for Orthopaedics and Rehabilitation |
16, Floor-1, Department of Musculoskeletal Physiotherapy, Shivajinagar, Pune
Pune
MAHARASHTRA |
9373429667
vaidehidingare@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute for Orthopedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Athletes with hamstring tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Self myofascial release on plantar surface of foot, warm up |
Bilateral plantar fascia release with a golf ball for 2 minutes per foot in a seated position, in addition to the warm-up protocol |
| Comparator Agent |
Warm up |
Jogging for 5 minutes and dynamic stretching which will include 20 repetitions each of lunge walking, high knee running and running butt kicks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Athletes with hamstring tightness (loss of ≥ 20 degrees of knee extension) |
|
| ExclusionCriteria |
| Details |
Any soft tissue or bony lower limb injuries in the past 6 months, Any contraindications to SMR |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified active knee extension test |
Pre-intervention and post-intervention testing done on the same day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2021 |
| Date of Study Completion (India) |
11/08/2022 |
| Date of First Enrollment (Global) |
20/12/2021 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized Controlled Trial that aims to check the immediate effect of self myofascial release on the plantar
surface of foot on hamstring flexibility in athletes. Hamstring muscle length
will be checked indirectly using the modified active knee
extension test. The subjects will be randomly allocated to either the control group
(20) or experimental (20) using computerized random table
method. The control group will be asked to follow a warm-up protocol. The experimental group will perform bilateral plantar fascia
release with a golf ball for 2 minutes per foot in a seated
position, in addition to the warm-up protocol. Outcome will be assessed pre-intervention as well post-intervention to compare the difference. |