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

NCT07815340 | Recruiting

• 1 other identifier: Ramsha Ali
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hamstring Muscle Strain

Keywords

ankle sprain; reinjury; reactive strength

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  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

  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

  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

  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

  at baseline 6 weeks post intervention

Study Arms (2)

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.

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.

Other: Active comparator: Time based rehabilitation

Interventions

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,

Criteria based rehabilitation

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.

Time based rehabilitation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Mescon Islamabad football academy

Islamabad, Federal, 051, Pakistan

RECRUITING

Mescon Islamabad Football Academy (MIFA)

Islamabad, Pakistan

RECRUITING

MeSH Terms

Conditions

Ankle Injuries; Reinjuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Ramsha Ali

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saadia Batool

CONTACT

03165131870; saadia.batool@riphah.edu.pk

rida zafar

CONTACT

03368753273; rida.zafar@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 11, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): January 5, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)