| CTRI Number |
CTRI/2025/04/084973 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| 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
|
Improving Hamstring Flexibility in College Students: A Comparison of Active Stabilization and Passive Stretching Techniques |
|
Scientific Title of Study
|
Effectiveness of active inhibitory stabilization lengthening technique compared to passive stretching for improving hamstring flexibility in college students with hamstring tightness-A three arm parallel group randomised controlled 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 |
PALAK BUNDELA |
| Designation |
Post graduate student |
| Affiliation |
Shree Bharatimaiya College of Optometry and Physiotherapy |
| Address |
Shree Bharatimaiya college of physiotherapy surat Vesu Main Road Street Vrudhashram behind Big Bazar Piplod Surat Gujarat 395007 Surat GUJARAT 394650 India |
| Phone |
08238733490 |
| Fax |
|
| Email |
bundelapalak22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sapna Chaudhary |
| Designation |
Assistant Professor |
| Affiliation |
Shree Bharatimaiya College of Optometry and Physiotherapy |
| Address |
Physiotherapy department Shree Bharatimaiya College of physiotherapy Vesu Main Road Behind Big Bazar Street Vrudhashram Piplod Surat Gujarat Surat GUJARAT 395007 India |
| Phone |
9714750652 |
| Fax |
|
| Email |
sapnakumari.112343@marwadiuniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
PALAK BUNDELA |
| Designation |
Post graduate student |
| Affiliation |
Shree Bharatimaiya College of Optometry and Physiotherapy |
| Address |
Shree Bharatimaiya College of Optometry and physiotherapy Vesu Main Road Behind Big Bazar Street Vrudhashram Piplod Surat Gujarat Surat GUJARAT 395007 India |
| Phone |
9714750652 |
| Fax |
|
| Email |
bundelapalak22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Bharatimaiya college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
Palak Bundela |
| Address |
Shree Bharatimaiya college of physiotherapy vesu surat |
| 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 Palak Bundela |
Physiotherapy clinic shree bharatimaiya college of physiotherapy |
vesu main road behind big bazar surat-395007 Surat GUJARAT |
08238733490
bundelapalak22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Shree Bharatimaiya College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hamstring muscle tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
active inhibitory restabilisation lengthening technique |
GROUP A -Active Inhibitory Re-Stabilisation technique
Participants will be asked to sit with their spine and pelvis in neutral alignment, and they will
be asked to extend their knee until the lumbar spine is moved out of neutral and into flexion, or strong resistance is felt in the hamstrings. At this stage, the physiotherapist will passively
support the leg while instructing participants to actively anterior tilt the pelvis. The stretch
should be held for 30 seconds and then repeated for 5 times |
| Comparator Agent |
Control group |
GROUP C – Control group
This group will not receive any stretching intervention and will continue with their daily
routine. |
| Comparator Agent |
Passive stretching |
GROUP B- Passive Stretching
Participants will lie supine with their knees completely extended and use an arm or shoulder to support their affected lower leg. Stabilize the opposite extremity along the anterior aspect of
the thigh using your other hand, a belt, or the assistance of another person. Flex the hip as much
as possible while the knee is at 0 degrees of extension and the hip is in neutral rotation. The
stretch should be held for 30 seconds and then repeated 5 times.
For all participants, hamstring stretches will be performed three days per week. And study
duration will be 2 weeks. A rest period of 15 seconds will be given between stretches |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. College-going students age group between 18 to 25.
2. Students who have having hamstring tightness using the Active knee extension test (less
than 125 degrees).
3. Students having unilateral hamstring tightness. (If tightness is present bilateral, the greater
tightness limb will be considered).
4. Students with BMI between 18.5 to 24.9 Kg/m2 |
|
| ExclusionCriteria |
| Details |
1. History of musculoskeletal problems, such as episodes of hamstring injuries or history of
any fractures or surgery of the lower limb.
2. Pain in the spine or hamstring muscle over the past 6 months
3. Any musculoskeletal disorder in the trunk (Scoliosis and lower extremity deformity) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Active knee extension test |
on basis of baseline pre-intervention and post-intervention [2 weeks] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
09/06/2025 |
| 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="0" 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
|
The study examines the effectiveness of Active Inhibitory Re-Stabilization (AIR) intervention compared to passive stretching in improving hamstring flexibility in college students with hamstring tightness. The study adopts a three-arm parallel-group randomized controlled design, involving college students aged 18 to 25 years who exhibit positive results on the Active Knee Extension (AKE) test, indicating hamstring tightness. Participants are randomly divided into three groups: Group A receives the AIR technique, Group B undergoes passive stretching, and Group C serves as a control group with no intervention. The AIR technique involves an active approach, where participants sit with a neutral spine and pelvis, extend their knee until resistance is felt, and then actively tilt the pelvis anteriorly while the therapist supports the leg. This stretch is held for 30 seconds and repeated five times per session, three sessions per week over two weeks. In contrast, the passive stretching group performs therapist-assisted stretches while lying supine, with the stretch similarly held for 30 seconds and repeated five times per session, also over two weeks. In that intervention, one session is given for one day, with alternate sessions on three days per week for two weeks. The control group does not receive any intervention and continues with their normal routine. The primary outcome measure used to assess the effectiveness of both interventions is the Active Knee Extension (AKE) test, which evaluates hamstring flexibility by measuring active knee extension using a universal goniometer. Measurements are taken before and after the two-week intervention period. The study aims to determine whether the AIR technique provides superior improvements in hamstring flexibility compared to passive stretching and no intervention. |