| CTRI Number |
CTRI/2024/10/075343 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of soft tissue mobilization vs massage gun on foot and pelvic posture- A Randomized Clinical Trail |
|
Scientific Title of Study
|
The Effect of Dynamic Soft Tissue Mobilization vs Percussion Massage Gun on Foot posture, Plantar Pressure and Pelvic tilt in individuals with asymptomatic hamstring tightness: A Randomized Clinical 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 |
Vaishnavi Naik Desai |
| Designation |
Post graduate student |
| Affiliation |
Dr. Prabhakar Kore Hospital and Medical Research Centre |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy, Nehru Nagar, Belagavi- Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9834468657 |
| Fax |
|
| Email |
footposture060@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Peeyoosha Gurudut |
| Designation |
Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy, Nehru Nagar, Belagavi- Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Peeyoosha Gurudut |
| Designation |
Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy, Nehru Nagar, Belagavi- Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research, Nehru Nagar, Belagavi- Karnataka, India
pin code- 590010 |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy, Nehru Nagar, Belagavi- Karnataka- India
590010 |
| 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 Peeyoosha Gurudut |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre |
Department of Orthopaedic Physiotherapy, OPD no.39, Room no. 18, Nehru Nagar Belagavi- Karnataka
Belgaum
KARNATAKA |
9844821355
peeyooshagurudut@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical committee of KAHER Institute of physiotherapy, Belagavi Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
asymptomatic hamstring tightness
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dynamic Soft Tissue Mobilization |
Dynamic soft tissue mobilisation will be given on bilateral hamstring for 3 times a week for 4 weeks. |
| Comparator Agent |
Percussion massage gun |
Percussion massage gun will be applied bilaterally on hamstring from 5 mins, 3 times a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
participants:
1.Diagnosed with bilateral hamstring tightness according to active knee extension test with more than 20°.
2.With acquired flexible foot deformity
3.All genders between 18-25 years of age.
4.Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Underwent surgery of lower extremity, spine or abdomen within the past 1 year
2. Diagnosed with radiating/ referred pain to lower extremity
3. Who had fractures of lower limb or spine
4. Diagnosed with congenital deformities of lower limb
5. Diagnosed case of peripheral vascular disease or deep venous thrombosis.
6. With open wound or local inflammation. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of foot posture using Foot Posture Index.
2.Assessment of plantar pressure using the Harris and Beath Foot printing Mat.
3.Assessment of pelvic tilt angle using Pelvic inclinometer.
4.Assessment of hamstring flexibility using Active knee extension test
|
at baseline and at the end of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| Date of Study Completion (India) |
20/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/01/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
Modification(s)
|
Effect of Dynamic Soft Tissue Mobilization vs Percussion Massage Gun on Foot posture, Plantar pressure and pelvic tilt in individuals with asymptomatic hamstring tightness: A Randomized Comtrollled Trial Aim of the study is to determine and compare the effect of dynamic soft tissue mobilization v/s percussion massage gun in individuals with asymptomatic hamstring tightness. Null hypothesis: There will be no difference between the effect of dynamic soft tissue mobilization and percussion massage gun on foot posture, plantar pressure and pelvic tilt in individuals with asymptomatic hamstring tightness. Alternative hypothesis: There will be difference between the effect of dynamic soft tissue mobilization and percussion massage gun on foot posture, plantar pressure and pelvic tilt in individuals with asymptomatic hamstring tightness. . A written informed consent will be given to the participants in their own language and those consenting to participate in the study will be presented with the intervention. Brief demographic data will be obtained from each prior to the assessment. Participants will be divided into two groups, group A (Dynamic soft tissue mobilization) and group B (Percussion massage gun). Pre-intervention outcome measures will be assessed and documented. Participants will be treated for 12 sessions, 3 times a week for 4 weeks |