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临床试验/NCT07815340
NCT07815340尚未招募不适用

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

Riphah International University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
试验地点
2
主要终点
Hop battery test (single, triple, and crossover hop) including limb symmetry index (LSI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: Experimental: Criteria based (Other)

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.

干预措施: Active comparator: Time based rehabilitation (Other)

结局指标

主要结局

Hop battery test (single, triple, and crossover hop) including limb symmetry index (LSI)

时间窗: 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

Tampa Scale of Kinesiophobia (TSK)

时间窗: 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

Reactive Strength Index (RSI)

时间窗: 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

Star Excursion Balance Test (SEBT)

时间窗: 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)

时间窗: 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

One-Repetition Maximum (1RM)

时间窗: 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)

时间窗: 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

Star Excursion Balance Test (SEBT/Y-Balance)

时间窗: At Baseline After 6 weeks

Evaluates dynamic balance and postural control; high reliability (ICC 0.85-0.91) and validated in athletes

ACL-RSI (Return to Sport after Injury Scale)

时间窗: 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)

Landing Error Scoring System (LESS)

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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