| CTRI Number |
CTRI/2025/07/090114 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
“Immediate Effects of Stretching and Tool-Based Massage on Hamstring Flexibility and Core Stability in Young Women”
|
|
Scientific Title of Study
|
Immediate effect of dynamic stretching versus Instrument-Assisted Soft
Tissue Mobilization on hamstring flexibility and core stability in
asymptomatic young adult females - An Experimental study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fatima Mohd Thoufeek |
| Designation |
MPT Scholar |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya college of physiotherapy, Musculoskeletal department,Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
7666180447 |
| Fax |
|
| Email |
fatimaerasali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dhvani Shah |
| Designation |
PhD Scholar |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya college of physiotherapy, Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
8450990859 |
| Fax |
|
| Email |
Dhvani@somaiya.edu |
|
Details of Contact Person
Public Query
|
| Name |
Fatima Mohd Thoufeek |
| Designation |
MPT Scholar |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya college of physiotherapy, Musculoskeletal department Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
7666180447 |
| Fax |
|
| Email |
fatimaerasali@gmail.com |
|
|
Source of Monetary or Material Support
|
| KJ Somaiya College of Physiotherapy, Mumbai, Maharashtra, India - 400022 |
|
|
Primary Sponsor
|
| Name |
Fatima Mohd Thoufeek |
| Address |
KJ Somaiya college of physiotherapy, Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, 400022 |
| 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 |
| Fatima Mohd Thoufeek |
KJ Somaiya College of Physiotherapy |
KJ Somaiya college of physiotherapy, Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, 400022
Mumbai (Suburban)
MAHARASHTRA |
7666180447
fatimaerasali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bilateral Hamstring tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dynamic streching of Hamstring |
The subjects will be standing upright with their feet parallel and facing forward while
holding onto parallel bars with both hands.
The subjects will be then instructed to contract their hip flexors intentionally once every 2
sec so that their hip joints flexes while keeping their knees extended so that their leg swings
up to the anterior aspect of their body and their hamstring muscles will be stretched
Each subject will perform 5 repetitions of the stretching exercise slowly while
learning to accurately perform the motion, and then 10 repetitions as quickly
and powerfully as possible without bouncing and in synchrony with the rhythm
of a digital metronome set to 30 beats/min (0.5 Hertz). Dynamic Stretching will
be performed for 5 min, comprising ten 30-s long sets with a 20-s rest period between sets during which the subject will be allowed to rest in the original standing position. Similarly stretching of other leg will be performed as well.
Total intervention duration : 5 minutes |
| Intervention |
Instrument assisted soft tissue mobilisation |
Participants will be instructed to lay down in a prone position for the application of cream
or lubricant to reduce friction between skin and IASTM tool.
The handlebar will then be applied using the scraping technique to the posterior aspect of
the affected thigh for two minutes each.
The direction of the application of IASTM was based on the direction and the shape of the
muscle fibers of the hamstring muscle. Thus, IASTM will be applied in a longitudinal
vertical direction from the top to the bottom and then reverse from the bottom to the top.Total internation duration : 4 minutes |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Participants of female gender between 18-30 years of age unable to achieve
Active knee extension (less than 20 degrees from full extension) bilaterally
and willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Participants having any recent musculoskeletal injury, neurological disorders,
cardiovascular conditions, history of surgery in the lower extremity in the last six months,
participants involved in any physiotherapy program in the past three months and pregnant
or postpartum females. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Active Knee Extension test for Hamstring Flexibility
Sahrmann core stability test using Pressure Biofeedback Unit |
Immediate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
31/07/2025 |
| 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 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
|
Core stability supports posture, balance, and injury prevention, while hamstring flexibility aids mobility and reduces musculoskeletal risk. Due to gender-based neuromuscular differences, studying young females is vital. Dynamic Stretching (DS) and IASTM improve flexibility, but IASTM’s effect on core stability is unclear. Exploring this link may reveal how improved flexibility influences core control.
To study the immediate effects of dynamic stretching vs Instrument-Assisted Soft Tissue Mobilization (IASTM) of hamstring muscles on hamstring flexibility and core stability in young asymptomatic females
|