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NCT Number: NCT07815340

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

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.

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Key information

Conditions

Hamstring Muscle Strain ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft Ankle Injuries Leg Injuries Reinjuries Wounds and Injuries

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: Criteria based

Other
  • 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

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Saadia Batool

CONTACT

[email protected]

03165131870

rida zafar

CONTACT

[email protected]

03368753273

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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