| CTRI Number |
CTRI/2025/02/080304 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| 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
|
Effects of Self Myofascial Release and Fascial Stretch Therapy on Hamstrings Flexibility and Dynamic Stability in Young Adults. |
|
Scientific Title of Study
|
Effects of Self Myofascial Release and Fascial Stretch Therapy Targeting Superficial Back Line Myofascial Meridian on Hamstrings Flexibility and Dynamic Stability in Young Adults: A Randomized Controlled 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 |
Aditi Saxena |
| Designation |
PG Student - MPT Orthopedics |
| Affiliation |
Guru Nanak Dev University, Amritsar, Punjab, India , affiliated under UGC, PCI, BCI, COA, NCTE |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India
Amritsar
PUNJAB
143005
India |
| Phone |
9811700493 |
| Fax |
|
| Email |
02aditisaxena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharnpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University, Amritsar, Punjab, India, affiliated under UGC, PCI, BCI, COA, NCTE |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India
Amritsar
PUNJAB
143005
India |
| Phone |
9877781035 |
| Fax |
|
| Email |
sharnpreet.pht@gndu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Saxena |
| Designation |
PG Student - MPT Orthopedics |
| Affiliation |
Guru Nanak Dev University, Amritsar, Punjab, India, affiliated under UGC, PCI, BCI, COA, NCTE |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India
Amritsar
PUNJAB
143005
India |
| Phone |
9811700493 |
| Fax |
|
| Email |
02aditisaxena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Health Centre(Physiotherapy Centre) of Guru Nanak Dev University, Amritsar, Punjab, India - 143005 |
|
|
Primary Sponsor
|
| Name |
Aditi Saxena |
| Address |
Department of Physiotherapy,
Guru Nanak Dev University, Amritsar, Punjab, India
Pin Code- 143005 |
| 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 Aditi Saxena |
Guru Nanak Dev University |
Health Centre (Physiotherapy Centre), Guru Nanak Dev University, Amritsar, Punjab , India- 143005
Amritsar
PUNJAB |
9811700493
02aditisaxena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Guru Nanak Dev University, Amritsar-143005 (India) (Established by the State Legislature Act No. 21 of 1969) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Young Adults with hamstrings tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Static Hamstrings Stretches for duration of 2 weeks. |
| Intervention |
Self Myofascial Release and Fascial Stretch Therapy |
Self Myofascial Release is a type of Myofascial Release usually applied with help of tool in order to release tension in tissues. Fascial Stretch Therapy uses application of its 10 fundamental principles to gain optimal length. Total duration of intervention will be 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with hamstrings tightness having knee extension angle greater than 20 degrees |
|
| ExclusionCriteria |
| Details |
Subjects below 18 years and above 30 years
Subjects with knee extension angle less than 20 degrees
Subjects with any history of recent hamstrings injury within past 6 months
Subjects with any pathological condition or neurological deficit
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Hamstrings Flexibility
2. Lumbar Flexibility
3. Cervical range of motion
4. Ankle Dorsiflexion range of motion
5. Foot Pronation and Tibial Torsion
6. Balance
|
Outcome variables will be assessed Baseline, on 1st day, after 1 week and after 2 weeks for both intervention group and control group.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
Final Enrollment numbers achieved (Total)= "57"
Final Enrollment numbers achieved (India)="57" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
|
Recruitment Status of Trial (Global)
|
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
|
This study will analyse the effects of Self Myofascial Release and Fascial Stretch Therapy on Hamstrings Flexibility, Lumbar Flexibility, Cervical range of motion, Dorsiflexion range of motion, Foot pronation and tibial torsion and balance. The study consists of 3 groups - Group 1 Self Myofascial Release, Group 2- Fascial Stretch Therapy and Group 3-Control group. For Self Myofascial Release and Fascial Stretch Therapy groups the respective interventions will be given 3 times a week for total duration of 2 weeks and for control group static hamstring stretches will be given 3 times a week for total duration of 2 weeks. |