| CTRI Number |
CTRI/2018/01/011479 [Registered on: 22/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
17/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effects of foam rolling, Stretching and Nerve Mobilization to improve flexibility of Hamstring in athletes |
|
Scientific Title of Study
|
Effectiveness of Self Myofascial Release, Static Stretching and Neural Tissue Mobilization on Hamstring Flexibility in Athletes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gatha Patel |
| Designation |
Intern |
| Affiliation |
Krishna Institute of Medical Sciences |
| Address |
Krishna College of Physiotherapy, Krishna Institute of Medical Sciences deemed university, Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
8888754604 |
| Fax |
|
| Email |
gathapatel1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Khushboo Bathia |
| Designation |
Lecturer |
| Affiliation |
Krishna Institute of Medical Sciences |
| Address |
Krishna College of Physiotherapy, Krishna Institute of Medical Sciences deemed university,Malkapur,Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
9011015331 |
| Fax |
|
| Email |
bathiakhushboo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gatha Patel |
| Designation |
Intern |
| Affiliation |
Krishna Institute of Medical Sciences |
| Address |
Krishna College of Physiotherapy, Krishna Institute of Medical Sciences deemed university, Karad
MAHARASHTRA
415110
India |
| Phone |
8888754604 |
| Fax |
|
| Email |
gathapatel1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Institute of Medical Sciences Deemed University |
|
|
Primary Sponsor
|
| Name |
Krishna Institute of Medical Sciences |
| Address |
Krishna Institute of Medical Sciences Deemed University, Malkapur, Karad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Gatha Patel |
Physiotherapy OPD |
Krishna Institute of Medical Sciences Deemed University, Karad
Satara
MAHARASHTRA |
8888754604
gathapatel1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Krishna Institute of Medical Sciences |
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 |
Combination of Self Myofascial Release and Static Stretching |
Self Myofascial Release with Foam rollers, to Hamstrings, holding tender spots for 30-90 seconds,Static Stretching to Hamstrings, 20-30 seconds hold, 1-4 repetitions |
| Comparator Agent |
Neural Tissue Mobilizaton |
Knee Extension, Medial Rotation of Hip,Foot Dorsiflexion,6 seconds hold, 3 repetitions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
Hamstring tightness of 20 degrees(inability to achieve greater than 160 degrees of knee extension with hip at 90 degrees of flexion) and also inability to reach 70 degrees hip flexion in a Straight Leg Raise |
|
| ExclusionCriteria |
| Details |
Fractures of Lower Limb
Any soft Tissue Injuriesof lower limb
With lower leg injury or surgical procedures in the previous 12 months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Active Knee Extension
|
Immediate
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Straight Leg Raise |
Immediate |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/10/2017 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is randomized, parallel group, single blinded study comparing the effects of Self Myofascial Release, Static Stretching and Neural Tissue Mobilization on Hamstring Flexibility in Athletes. The first group will receive Self Myofascial Release and Static Stretching. The second group will receive Neural Tissue Mobilization. The outcome measures are Active Knee extension and Straight Leg Raise. The effects of the treatment given to each group will be noted immediately using the outcome measures. |