Hamstring Muscle StrainNCT07815340
Effects Of Criteria Versus Time-Based Rehabilitation On Return To Play In Football Players
A study testing Experimental: Criteria based and Active comparator: Time based rehabilitation in people with Hamstring Muscle Strain, run by Riphah International University at 2 sites in Pakistan.
Trial summary
This randomized controlled trial compares criteria-based rehabilitation (CBR) with time-based rehabilitation (TBR) for football players aged 18-35 with ACL reconstruction, hamstring strain, or ankle sprain. Both groups receive a six-week supervised rehabilitation program; the progression rules differ between groups. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Hamstring Muscle Strain
- What is being tested?
- Experimental: Criteria based and Active comparator: Time based rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesPakistan
- Study dates
- 25 Sep 2026to 5 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Injury Type: ACL reconstruction, hamstring strain, and ankle sprain.
- Rehabilitation Phase: Phase 3 for ACL injuries, Phase 1\&2 for hamstring strains and ankle sprains.
- Football Activity: Active at club or regional football level
Who cannot join
- History of Major surgery in affected limb
- Chronic neurological or musculoskeletal disorder
- Non-football athletes
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Mescon Islamabad football academy
Islamabad, Federal, 051
Saadia Batool, 03165131870, saadiabatool@riphah.edu.pk
- Recruiting
Mescon Islamabad Football Academy (MIFA)
Islamabad
Saadia Batool, +92308 5222762, saadia.batool@riphah.edu.pk
About this study
This randomized controlled trial compares criteria-based rehabilitation (CBR) with time-based rehabilitation (TBR) for football players aged 18-35 with ACL reconstruction, hamstring strain, or ankle sprain. Both groups receive a six-week supervised rehabilitation program; the progression rules differ between groups.
Read the detailed description
Eligible football players will be recruited from local football clubs and academies in Islamabad Capital Territory and Rawalpindi. Written informed consent will be obtained. Participants will be randomly allocated 1:1 using a concealed, computer-generated sequence. Baseline demographic, functional, and psychological measures will be collected. Both groups follow the same general phase-based rehabilitation structure under licensed physiotherapist supervision. CBR progression depends on objective functional and psychological milestones; TBR progression follows fixed time intervals and return-to-play clearance at week 6 irrespective of milestones. Progression is paused or regressed if pain is ≥4/10 on VAS or swelling returns.
- Conditions
- Hamstring Muscle Strain
- Being tested
- Experimental: Criteria based, Active comparator: Time based rehabilitation
- Keywords
- ankle sprain, reinjury, reactive strength
- Medical subject headings
- Ankle Injuries, Reinjuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Criteria basedOther
- Weeks 1-2: Focus on pain control, ROM restoration, and isometric strengthening (low intensity, 3-4 sets of 10-15 reps).
- Weeks 2-4: Closed-chain and eccentric strengthening (moderate intensity, 3 sets of 12-15 reps), balance training, and jogging once LSI ≥ 80%.
- Weeks 4-6: Plyometrics, agility, sprinting, and football-specific drills (high intensity, 4-5 sets, 80-85% effort).
Participants will only progress or return to play upon meeting the criteria: hop test LSI ≥ 90%, SEBT symmetry, improved ACLRSI,
Active comparator: Time based rehabilitationOther
Weeks 1-2: Pain reduction and early strengthening (low intensity, 3 sets of 10-12 reps).
- Weeks 2-4: General strengthening, proprioception, and jogging (moderate intensity, 3 sets of 12-15 reps).
- Weeks 4-6: Plyometrics, agility, sprinting, and football-specific drills (high intensity, 70-85% effort) All participants will be cleared for return to play at the end of Week 6, regardless of whether they have achieved functional or psychological milestones, reflecting a traditional time-driven rehabilitation approach. This design reflects conventional rehabilitation models used in previous comparative studies, in which exercise progression and RTP clearance are determined by elapsed time rather than by functional recovery.
| Study group | Role | What they receive |
|---|---|---|
| Criteria based rehabilitation | Experimental | Participants in this group will undergo a 6-week criteria-based rehabilitation program,consisting of 3-5 supervised sessions per week, each lasting 45-60 minutes. Exercise intensity will be progressively increased from low (40-50% of maximum effort) during early phases to high intensity (70-85%) in later stages, depending on individual performance and pain tolerance. Progression will depend on achieving specific functional and psychological benchmarks rather than elapsed time. Receives: Other: Experimental: Criteria based |
| Time based rehabilitation | Active comparator | Participants in this group will follow a fixed 6-week time-based program with 3-5 sessions per week (45-60 minutes/session). Exercise intensity will progress automatically from low to high each week, regardless of functional test results. Receives: Other: Active comparator: Time based rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hop battery test (single, triple, and crossover hop) including limb symmetry index (LSI)
A tool to assess lower-limb strength, power, symmetry and functional performance in athletes post-injury; demonstrates good test-retest reliability (ICC ≈ 0.85-0.97) and valid discriminatory ability, though its capacity to predict re-injury remains inconsistent.
Depends on individual hop test; usually reported as distance. Higher distance generally indicates better performance
Measured: At baseline, 0 weeks 6 weeks post-intervention
Star Excursion Balance Test (SEBT)
Evaluates dynamic balance and postural control; high reliability (ICC 0.85-0.91) and validated in athletes.
no fixed universal minimum/maximum; reach distance is recorded in cm and may be normalized to limb length as a percentage Higher reach distance/normalized score = better dynamic postural balance
Measured: At Baseline After 6 weeks
Anterior Cruciate Ligament -RSI (Return to Sport after Injury Scale)
Measures psychological readiness and fear of re-injury; strong internal consistency (α = 0.94) and test-retest reliability (ICC = 0.90) 0-100 Higher score = greater psychological readiness to return to sport
Measured: At baseline After 6 weeks of intervention
Tampa Scale of Kinesiophobia (TSK)
Assesses fear of movement and re-injury; validated in musculoskeletal populations with good internal consistency (α = 0.810.87) and test-retest reliability (ICC = 0.84-0.90) 17-68 for the 17-item version Higher score = greater fear of movement/reinjury
Measured: at baseline at 6 weeks post intervention
Landing Error Scoring System (LESS)
The LESS is a movement screen used to identify specific movement patterns of the lower extremities that may increase an individual's risk for noncontact ACL injury.
0-17 Lower score = better landing technique; higher score = more landing errors
Measured: at baseline at 6 weeks post intervention
Reactive Strength Index (RSI)
Measures reactive strength and stretch-shortening cycle efficiency; demonstrates good test-retest reliability (ICC = 0.87) in athletes. No fixed minimum/maximum; calculated as jump height ÷ ground contact time Higher value = better reactive strength/stretch-shortening-cycle performance
Measured: at baseline 6 weeks post intervention
One-Repetition Maximum (1RM)
This tool is used to assess the strength of the athlete objectively. No universal fixed minimum/maximum; expressed as the maximum load lifted once, usually in kg Higher value = greater muscular strength
Measured: at baseline 6 weeks post intervention
Y-Balance Test (YBT)
The Y Balance Test is a functional screening tool used to assess dynamic balance, core stability, and injury risk in athletes and patients Composite score: 0-100%; individual reach distances are also recorded Higher score = better dynamic balance
Measured: at baseline 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start25 Sep 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring Muscle StrainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramsha Ali, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815340
- Sponsor's protocol ID
- Ramsha Ali
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Criteria Versus Time-Based Rehabilitation On Return To Play In Football Players
- ClinicalTrials.gov ID
- NCT07815340
- Acronym / sponsor ID
- Ramsha Ali
- Conditions
- Hamstring Muscle Strain
- Keywords
- ankle sprain, reinjury, reactive strength
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial compares criteria-based rehabilitation (CBR) with time-based rehabilitation (TBR) for football players aged 18-35 with ACL reconstruction, hamstring strain, or ankle sprain. Both groups receive a six-week supervised rehabilitation program; the progression rules differ between groups.
Detailed description
Eligible football players will be recruited from local football clubs and academies in Islamabad Capital Territory and Rawalpindi. Written informed consent will be obtained. Participants will be randomly allocated 1:1 using a concealed, computer-generated sequence. Baseline demographic, functional, and psychological measures will be collected. Both groups follow the same general phase-based rehabilitation structure under licensed physiotherapist supervision. CBR progression depends on objective functional and psychological milestones; TBR progression follows fixed time intervals and return-to-play clearance at week 6 irrespective of milestones. Progression is paused or regressed if pain is ≥4/10 on VAS or swelling returns.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Criteria based rehabilitation | Experimental | Other: Experimental: Criteria basedParticipants in this group will undergo a 6-week criteria-based rehabilitation program,consisting of 3-5 supervised sessions per week, each lasting 45-60 minutes. Exercise intensity will be progressively increased from low (40-50% of maximum effort) during early phases to high intensity (70-85%) in later stages, depending on individual performance and pain tolerance. Progression will depend on achieving specific functional and psychological benchmarks rather than elapsed time. |
| Time based rehabilitation | Active comparator | Other: Active comparator: Time based rehabilitationParticipants in this group will follow a fixed 6-week time-based program with 3-5 sessions per week (45-60 minutes/session). Exercise intensity will progress automatically from low to high each week, regardless of functional test results. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Injury Type: ACL reconstruction, hamstring strain, and ankle sprain.
- Rehabilitation Phase: Phase 3 for ACL injuries, Phase 1\&2 for hamstring strains and ankle sprains.
- Football Activity: Active at club or regional football level
Key exclusion criteria (3 listed)
- History of Major surgery in affected limb
- Chronic neurological or musculoskeletal disorder
- Non-football athletes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Criteria based* Weeks 1-2: Focus on pain control, ROM restoration, and isometric strengthening (low intensity, 3-4 sets of 10-15 reps). * Weeks 2-4: Closed-chain and eccentric strengthening (moderate intensity, 3 sets of 12-15 reps), balance training, and jogging once LSI ≥ 80%. * Weeks 4-6: Plyometrics, agility, sprinting, and football-specific drills (high intensity, 4-5 sets, 80-85% effort). Participants will only progress or return to play upon meeting the criteria: hop test LSI ≥ 90%, SEBT symmetry, improved ACLRSI, | Other | Criteria based rehabilitation |
| Active comparator: Time based rehabilitationWeeks 1-2: Pain reduction and early strengthening (low intensity, 3 sets of 10-12 reps). * Weeks 2-4: General strengthening, proprioception, and jogging (moderate intensity, 3 sets of 12-15 reps). * Weeks 4-6: Plyometrics, agility, sprinting, and football-specific drills (high intensity, 70-85% effort) All participants will be cleared for return to play at the end of Week 6, regardless of whether they have achieved functional or psychological milestones, reflecting a traditional time-driven rehabilitation approach. This design reflects conventional rehabilitation models used in previous comparative studies, in which exercise progression and RTP clearance are determined by elapsed time rather than by functional recovery. | Other | Time based rehabilitation |
Primary outcome
Hop battery test (single, triple, and crossover hop) including limb symmetry index (LSI)
Time frame: At baseline, 0 weeks 6 weeks post-intervention
A tool to assess lower-limb strength, power, symmetry and functional performance in athletes post-injury; demonstrates good test-retest reliability (ICC ≈ 0.85-0.97) and valid discriminatory ability, though its capacity to predict re-injury remains inconsistent. Depends on individual hop test; usually reported as distance. Higher distance generally indicates better performance
Star Excursion Balance Test (SEBT)
Time frame: At Baseline After 6 weeks
Evaluates dynamic balance and postural control; high reliability (ICC 0.85-0.91) and validated in athletes. no fixed universal minimum/maximum; reach distance is recorded in cm and may be normalized to limb length as a percentage Higher reach distance/normalized score = better dynamic postural balance
Anterior Cruciate Ligament -RSI (Return to Sport after Injury Scale)
Time frame: At baseline After 6 weeks of intervention
Measures psychological readiness and fear of re-injury; strong internal consistency (α = 0.94) and test-retest reliability (ICC = 0.90) 0-100 Higher score = greater psychological readiness to return to sport
Tampa Scale of Kinesiophobia (TSK)
Time frame: at baseline at 6 weeks post intervention
Assesses fear of movement and re-injury; validated in musculoskeletal populations with good internal consistency (α = 0.810.87) and test-retest reliability (ICC = 0.84-0.90) 17-68 for the 17-item version Higher score = greater fear of movement/reinjury
Landing Error Scoring System (LESS)
Time frame: at baseline at 6 weeks post intervention
The LESS is a movement screen used to identify specific movement patterns of the lower extremities that may increase an individual's risk for noncontact ACL injury. 0-17 Lower score = better landing technique; higher score = more landing errors
Reactive Strength Index (RSI)
Time frame: at baseline 6 weeks post intervention
Measures reactive strength and stretch-shortening cycle efficiency; demonstrates good test-retest reliability (ICC = 0.87) in athletes. No fixed minimum/maximum; calculated as jump height ÷ ground contact time Higher value = better reactive strength/stretch-shortening-cycle performance
One-Repetition Maximum (1RM)
Time frame: at baseline 6 weeks post intervention
This tool is used to assess the strength of the athlete objectively. No universal fixed minimum/maximum; expressed as the maximum load lifted once, usually in kg Higher value = greater muscular strength
Y-Balance Test (YBT)
Time frame: at baseline 6 weeks post intervention
The Y Balance Test is a functional screening tool used to assess dynamic balance, core stability, and injury risk in athletes and patients Composite score: 0-100%; individual reach distances are also recorded Higher score = better dynamic balance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramsha Ali principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Criteria based and Active comparator: Time based rehabilitation in people with Hamstring Muscle Strain, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saadia Batool (03165131870, saadia.batool@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hop battery test (single, triple, and crossover hop) including limb symmetry index (LSI) (time frame: At baseline, 0 weeks 6 weeks post-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.