| CTRI Number |
CTRI/2024/04/066345 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| 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
|
Comparing The Temporary Response Of Static Stretching And Isometric Relaxation On Hamstring Flexibility In Youngsters: Athletic And Non-Athletic Populations |
|
Scientific Title of Study
|
Short-Term Effect Of Static Stretching And Isometric Relaxation On Hamstring Flexibility Among Athletic And Non Athletic Young Adults: A Comparative 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 |
Shalvi Shahi |
| Designation |
Research Student |
| Affiliation |
Galgotias university |
| Address |
Department Of Physiotherapy
Room no. E003
Galgotias University
Greater Noida
UP
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7905204061 |
| Fax |
|
| Email |
shalvi99shahi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalvi Shahi |
| Designation |
Research Student |
| Affiliation |
Galgotias university |
| Address |
Department Of Physiotherapy
Room no. E003
Galgotias University
Greater Noida
UP
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7905204061 |
| Fax |
|
| Email |
shalvi99shahi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanghamitra Jena |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy
SAHS
Galgotias University
Greater Noida
UP
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9776961858 |
| Fax |
|
| Email |
sanghamitra.bpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias University Greater Noida UP |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Shalvi Shahi |
Galgotias University |
Department of Physiotherapy
Room no. E003
Galgotias University
Greater Noida
UP
Gautam Buddha Nagar
UTTAR PRADESH |
7905204061
shalvi99shahi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethics Committee, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HAMSTRING TIGHTNESS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
STATIC STRETCHING
ISOMETRIC RELAXATION IN ATHLETES |
The procedure begins with the screening of 50 individuals for inclusion criteria, then the procedure will be explained and an informed consent form will be taken from the individuals. In the first phase pre intervention assessment taken in which the individuals will be divided into two different groups athletic and non-athletic and both will be performing the SLR (straight leg raise test), AKE (Active knee extension test) and Sit and reach test. Then subject will perform warm up exercise in room with static stretching and isometric relaxation followed up by twice a week for duration of four week.
In the second phase post assessment taken with the same technique SLR (straight leg raise), AKE (Active knee extension test) and Sit and reach test.
STUDY PROTOCOL:
Subjects will perform warm up exercise in room then they perform the static stretching and isometric relaxation. Static Stretching: The subjects will be instructed to attain lengthy sitting position with both knees straight, lift their arms, bend at the pelvis, and try to touch their toes. The stretch will be hold for 30 seconds, then performed four times, interspersed with 30-second rest intervals. Isometric relaxation: The subjects will be asked for kneeling, stretching their dominant leg straight forward while extending their knee. Then we will advise them to bend at the pelvis to feel a stretch in their hamstrings, press their heel on the ground for ten seconds, and then relax. This will be performing for five times, pausing for ten seconds in between
|
| Comparator Agent |
STATIC STRETCHING AND ISOMETRIC RELAXATION IN NON-ATHLETES |
The procedure begins with the screening of 50 individuals for inclusion criteria, then the procedure will be explained and informed consent form will be taken from the individuals. In the first phase pre intervention assessment taken in which the individuals will be divided into two different groups athletic and non-athletic and both will be performing the SLR (straight leg raise test), AKE (Active knee extension test) and Sit and reach test. Then subject will perform warm up exercise in room with static stretching and isometric relaxation followed up by twice a week for duration of four week.
In the second phase post assessment taken with the same technique SLR (straight leg raise), AKE (Active knee extension test) and Sit and reach test.
STUDY PROTOCOL:
Subjects will perform warm up exercise in room then they perform the static stretching and isometric relaxation. Static Stretching: The subjects will be instructed to attain lengthy sitting position with both knees straight, lift their arms, bend at the pelvis, and try to touch their toes. The stretch will be hold for 30 seconds, then performed four times, interspersed with 30-second rest intervals. Isometric relaxation: The subjects will be asked for kneeling, stretching their dominant leg straight forward while extending their knee. Then we will advise them to bend at the pelvis to feel a stretch in their hamstrings, press their heel on the ground for ten seconds, and then relax. This will be performing for five times, pausing for ten seconds in between
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Athletes and non-athletes
2. Individuals with no history of knee and hip injury.
3. Subjects with at least 15° loss of knee extension, when hip held in 90° flexion were included in the study.
4. The active straight leg raising (ASLR) range was between 30 - 70 ranges
|
|
| ExclusionCriteria |
| Details |
1. Subjects without Hamstring tightness
2. Subject with any past hamstring injury with in last 2 years
3. low back pain since past 2 months.
4. Subjects presenting health problems unassociated with hamstring
5. Lumbar and lower limb neurological compromise were excluded
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Active knee Extension
2 straight-leg raises
3 Sit and reach test |
Baseline and after 4 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
05/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
This study involves the static stretching and isometric relaxation to determine the hamstring flexibility in athletes and non- athletes. The
hamstrings are essential muscles that are crucial for the function of the lower
limbs. A set of muscles called the hamstrings controls the movement of the hip
and knee joints as well as the alignment of the pelvis and spine. These
muscles are essential for a variety of tasks, including walking and intense
sports. The procedure begins with the screening of 50 individuals
for inclusion criteria, then the procedure will be explained and informed
consent form will be taken from the individuals. In the first phase pre
intervention assessment taken in which the individuals will be divided into two
different groups athletic and non-athletic and both will be performing the SLR (straight
leg raise test), AKE (Active knee extension test) and Sit and reach test. Then
subject will perform warm up exercise in room with static stretching and
isometric relaxation followed up by twice a week for duration of four week. In the second
phase post assessment taken with the same technique SLR (straight leg raise),
AKE (Active knee extension test) and Sit and reach test. |