| CTRI Number |
CTRI/2023/10/058177 [Registered on: 03/10/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| 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
|
A trial to study the usage of an instrument and roller for releasing the tightness of lateral thigh muscle and studying its immediate effects on flexibility and performance in long distance runners |
|
Scientific Title of Study
|
Immediate effects of instrument assisted soft tissue mobilization and foam rolling on flexibility and performance in long distance runners with iliotibial band tightness-A randomized control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vedant Dattatraya Ballal |
| Designation |
post graduation student |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy
11/12, Thube park, Shivajinagar,Pune -411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9834430621 |
| Fax |
|
| Email |
vedantballal184@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Gangwal PT ( New Guide) |
| Designation |
Associate Professors |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy
11/12, Thube park, Shivajinagar,Pune -411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9960323333 |
| Fax |
|
| Email |
anandgangwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Gangwal PT |
| Designation |
Associate Professors |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy
11/12, Thube park, Shivajinagar,Pune -411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9960323333 |
| Fax |
|
| Email |
anandgangwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of sports physiotherapy , 1st floor,Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy 11/12 Thube Park Shivaji Nagar Pune 411005 |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy
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 Vedant Ballal |
Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy |
Department of sports physiotherapy , 1st floor,Sancheti Institute for Orthopaedics and Rehabiliation College of Physiotherapy 11/12 Thube Park Shivaji Nagar Pune 411005
Pune
MAHARASHTRA |
9834430621
vedantballal184@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopeadics and Rehabilitaion Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foam rolling on Iliotibial band |
Foam rolling on Iliotibial band given for 3 min actively by the participants |
| Intervention |
Instrument Assisted Soft Tissue Mobilization on Iliotibial band |
Instrument Assisted Soft Tissue Mobilization on Iliotibial band will be given for 2 min from greater trochanter of femur to Iliotibial band insertion . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Well trained runner with age 18-40 years
2. Both male and female runners
3. Running experience at least 3 yrs.
4. Having running practice at least 4 days per week
5. Runners with positive modified Ober test measured with inclinometer with angle 26 ° and less.
|
|
| ExclusionCriteria |
| Details |
Any recent injuries or fracture of Lower limb
Any recent lower limb surgery
Any skin rash or infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Iliotibial band tightness |
Immediately post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 5km run time |
post 48 hrs |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/10/2023 |
| Date of Study Completion (India) |
30/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/05/2024 |
|
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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the current study is to find the immediate effects of instrument assisted soft tissue mobilization on flexibility and performance in long distance runners with iliotibial band tightness.
Primary hypothesis for current study is both IASTM and Foam rolling will have similar effects on flexibility and performance in long distance runners with iliotibial band tightness.Need of the study is to find out immediate effects of IASTM on iliotibial band tightness and performance in ling distance runners as evidence supporting the immediate effect of IASTM on iliotibial band tightness in running population on flexibility and performance are very limited. |