| CTRI Number |
CTRI/2025/01/079026 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Immediate Effects of Myofascial Release and Mechanical Vibration Therapy on Muscle Fatigue and recovery from muscle tiredness |
|
Scientific Title of Study
|
Immediate Impact of Myofascial Release and Mechanical Vibration Therapy on Recovery from Muscle Fatigue |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/NEW/IND/2021/1807 |
Other |
| ECR/358/Indt/DL/2022 |
Other |
| IORG0011725 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Shukla |
| Designation |
Student |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University, Department of Physiotherapy, Orthopedics Division, B-421
Sohna road Gurugram Haryana, India (122103)
Gurgaon HARYANA 122103 India |
| Phone |
7987430308 |
| Fax |
|
| Email |
v.shukla7@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anand Kumar singh |
| Designation |
Head Of Department |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University, Department of Physiotherapy, Orthopedics Division, B-422-
Sohna road Gurugram Haryana, India (122103)
Gurgaon HARYANA 122103 India |
| Phone |
8607370746 |
| Fax |
|
| Email |
anand01physio@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr kamran ali |
| Designation |
Associate Professor |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University, Department of Physiotherapy, Sports Division, B-412- Sohna road Gurugram Haryana, India (122103)
Gurgaon HARYANA 122103 India |
| Phone |
9540686786 |
| Fax |
|
| Email |
k.alisportsphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| GD Goenka University Sohna road Gurugram Haryana 122103 |
|
|
Primary Sponsor
|
| Name |
Vishal Shukla |
| Address |
GD Goenka University, Department of Physiotherapy, Orthopedics Division, B-421
Sohna road Gurugram Haryana, India (122103) |
| 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 Vishal Shukla |
GD Goenka University |
Department of Physiotherapy, Orthopedics Division, B-421
GD Goenka University Sohna road Gurugram Haryana, India (122103) Gurgaon HARYANA |
7987430308
v.shukla7@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Waves Women Empowerment Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MUSCLE FATIGUE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mechanical Vibration |
Muscle fascial gun with an amplitude of 9 mm equipped with a ball head will be used to provide mechanical vibration over the calves, Hamstrings, Quadriceps and Gluteus muscles course for 40 minutes. |
| Intervention |
Myofascial release |
Myofascial release intervention will be given by using knuckles to apply vertical stroking caudally over calves, Hamstrings Quadriceps and Gluteus muscles course, with pressure exerted along the tissue and by applying deep digital tension (with the thumb or fingers) on the involved area while actively as well as passively moving the tissue from a shortened to a lengthened position along with Shaking the muscles for 40 minutes.
|
| Comparator Agent |
Passive rest |
Passive rest will be given by advising the participant to be seated on a chair in a quite well lit room for 40 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-30 yrs, Meeting the lower level criteria on IPAQ, Sedentary or moderately active individuals, Both Male and female.
|
|
| ExclusionCriteria |
| Details |
Individuals with acute injuries to the lower limbs.
History of musculoskeletal disorders, Any chronic health conditions impacting muscle function (e.g., diabetes, cardiovascular diseases).Any musculoskeletal/ neurological condition.
ongoing medication that can alter muscle function. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vertical jump power
|
pre fatigue protocol ,pre-intervention, post-intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| visual analogue scale- fatigue (VAS-F) |
pre fatigue protocol ,pre-intervention, post-intervention |
|
|
Target Sample Size
|
Total Sample Size="87" Sample Size from India="87"
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 1 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study will involve 87 participants divided into three groups: Mechanical vibration therapy (Group 1), Myofascial release technique (Group 2), and passive rest (Group 3). Pre- intervention assessment will be done prior to the application of the fatigue protocol, pre- intervention and post-intervention to find the immediate effect of these three techniques on muscle fatigue induced with a muscle fatigue protocol in which participants will perform 5 vertical jumps followed by 30m sprint run. Group 1: Mechanical vibration therapy will include fascial gun with an amplitude of 9 mm equipped with a ball head will be used to provide mechanical vibration over the calves, Hamstrings, Quadriceps and Gluteus muscles course for 40 minutes. Group 2: Myofascial release technique will be given by using knuckles to apply vertical stroking caudally over calves, Hamstrings Quadriceps and Gluteus muscles course, with pressure exerted along the tissue and by applying deep digital tension (with the thumb or fingers) on the involved area while actively as well as passively moving the tissue from a shortened to a lengthened position along with Shaking the muscles for 40 minutes. Group 3: Passive rest will be given by advising the participant to be seated on a chair in a quite well lit room for 40 minutes. Assessment and Analysis: The pre-intervention baseline data of the dependent variables consisting of Vertical jump power, VAS-F to assess level of fatigue. The first reading will be taken prior to the fatigue protocol ; second reading will be taken before intervention, and third reading will be taken after intervention. |