Effects Of Criteria Versus Time-Based Rehabilitation On Return To Play In Football Players

September 6, 2026 updated by: Riphah International University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of Major surgery in affected limb
  • Chronic neurological or musculoskeletal disorder
  • Non-football athletes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Criteria based rehabilitation
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.
Other: 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,
Active Comparator: Time based rehabilitation
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.
Other: Active comparator: Time based rehabilitation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline, 0 weeks 6 weeks post-intervention
Star Excursion Balance Test (SEBT/Y-Balance)
Time Frame: At Baseline After 6 weeks
Evaluates dynamic balance and postural control; high reliability (ICC 0.85-0.91) and validated in athletes
At Baseline After 6 weeks
ACL-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)
At baseline After 6 weeks of intervention
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)
at baseline at 6 weeks post intervention
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
at baseline at 6 weeks post intervention
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.
at baseline 6 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Ramsha Ali, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

January 5, 2027

Study Registration Dates

First Submitted

September 6, 2026

First Submitted That Met QC Criteria

September 6, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ramsha Ali

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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