| CTRI Number |
CTRI/2025/12/098623 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| 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
|
Effect of open chain kinetic vs closed chain kinetic exercise among Athletes with Hamstring Strain |
|
Scientific Title of Study
|
Effect of open chain kinetic vs closed chain kinetic exercise with common use of blood flow restriction therapy among Athletes with Hamstring Strain |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arti Gupta |
| Designation |
MPT Student |
| Affiliation |
Arti Gupta |
| Address |
Department of Physiotherapy Amity Institute of Health and Allied Sciences Amity University Noida Sector 125
Department of Physiotherapy Amity Institute of Health and Allied Sciences Amity University Noida Sector 125
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8448178995 |
| Fax |
1 |
| Email |
arti.gupta@s.amity.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Arti Gupta |
| Designation |
MPT Student |
| Affiliation |
Arti Gupta |
| Address |
Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Noida, Sector 125
Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Noida, Sector 125
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8448178995 |
| Fax |
1 |
| Email |
arti.gupta@s.amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Arti Gupta |
| Designation |
MPT Student |
| Affiliation |
Arti Gupta |
| Address |
Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Noida, Sector 125
Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Noida, Sector 125
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8448178995 |
| Fax |
1 |
| Email |
arti.gupta@s.amity.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
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 |
| Arti Gupta |
Axon Physiotherapy Rehab Centre |
Amity Institute of Health and Allied Sciences, Amity University, Noida, Sector 125
Gautam Buddha Nagar
UTTAR PRADESH |
8448178995
1
arti.gupta@s.amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Neha Gupta |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hamstring strain injury |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Flow Restriction Therapy without additional exercise intervention. |
Intervention:
All participants will receive supervised, group specific exercise training with blood flow restriction at sixty to eighty percent arterial occlusion and twenty to thirty percent of one repetition maximum, three sessions per week for four weeks. |
| Comparator Agent |
Open Chain Kinetic vs Closed Chain Kinetic with common use of Blood Flow Restriction Therapy |
Muscle strength will be evaluated using the Sit to Stand Test and the Timed Up and Go Test. Additional assessments such as heel walking, toe walking, and rising from supine will be used to measure functional lower limb strength. Hamstring flexibility will be assessed using the Ninety Straight Leg Raise Test and the Bent Knee Stretch Test. Pain level will be recorded using the Numerical Pain Rating Scale. Functional performance will be evaluated through the Single Leg Hop Test and Sprint Speed Test.
Group A (Open Chain Kinetic Exercise with Blood Flow Restriction):
Prone hamstring curls, prone knee flexion, and isometric knee flexion.
Group B (Closed Chain Kinetic Exercise with Blood Flow Restriction):
Squats, lunges, and step downs.
3 sessions per week for four weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
a. The participants, both male and female, shall be between eighteen and thirty five years of age, representing the young adult group.
b. The study sample will include participants from both genders.
c. The participants must have a hamstring strain diagnosed either by an orthopedician or through special tests such as the Ninety Ninety Straight Leg Raise Test or the Bend Knee Stretch Test as described by Heiderscheit and colleagues in the Journal of Orthopaedic and Sports Physical Therapy.
d. The inclusion time frame will range from the acute to subacute stage, that is, from seven to twenty one days after injury, as suggested by Kisner and Colby in Therapeutic Exercise Foundations and Techniques, seventh edition, F A Davis Company, two thousand seventeen.
e. All participants must be willing and able to provide informed consent. |
|
| ExclusionCriteria |
| Details |
a.History of fracture of lower extremities, ankle sprain
b.Any history of musculoskeletal condition like PIVD.
c.Any precious history of hamstring surgery
d.Grade III hamstring strain
e.Neurological disorder
f.Any cardiovascular or systemic illness contraindicating exercise or BFRT
g.Non consenting individuals.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome measure
Hamstring muscle strength
Functional Assessed by the Sit to Stand Test and the Time Up and Go TUG
Functional performance
Performance in above functional tests Sit and Stand Test serves as both strength and overall functional status indicators in athletic contexts
|
Baseline and post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome measure
Flexibility
Measured using the 90-90 Straight Leg Raise Test & Bent Knee Stretch Test to determine hamstring range of motion
Pain Levels
Recorded via the Numerical Pain Rating Scale NPRS to monitor symptom progression through rehabilitation
|
Baseline & post |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
20/12/2025 |
| 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="9" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 aims to find out the effect of Open Chain Kinetic Exercises and Closed Chain Kinetic Exercises when combined with Blood Flow Restriction Therapy among athletes with hamstring strain injury It focuses on improvement in muscle strength flexibility pain relief and readiness to return to sports The study will also evaluate the safety and tolerance of both types of exercise programs in athletes
Aims and Objectives
Aim To study the effect of Open Chain Kinetic Exercises and Closed Chain Kinetic Exercises with the use of Blood Flow Restriction Therapy among athletes who have hamstring strain injury
Objectives
To compare the effectiveness of Open Chain Kinetic Exercise with Blood Flow Restriction Therapy and Closed Chain Kinetic Exercise with Blood Flow Restriction Therapy in improving muscle strength flexibility and function in athletes with hamstring strain injury
To study the difference in pain reduction recovery of flexibility and readiness to return to sports between the two exercise programs
To evaluate the safety and tolerance of both exercise programs in athletes
Hypothesis
Alternate Hypothesis There is a significant difference between Open Chain Kinetic Exercises and Closed Chain Kinetic Exercises when used with Blood Flow Restriction Therapy among athletes with hamstring strain injury
Null Hypothesis There is no significant difference between Open Chain Kinetic Exercises and Closed Chain Kinetic Exercises when used with Blood Flow Restriction Therapy among athletes with hamstring strain injury |