NCT07201597

Brief Summary

This clinical trial aims to investigate the correlation between psychological readiness, knee function, and isokinetic performance after anterior cruciate ligament reconstruction (ACLR) using the Peroneus Longus tendon graft (PLT). ACL injuries are common among athletes, and the standard treatment is ACL reconstruction surgery (ACLR). However, the success of the surgery does not solely depend on physical recovery but also on the psychological readiness of athletes to return to their sport. This study focuses on athletes who have undergone ACLR using the Peroneus Longus tendon (PLT). The primary objective is to compare psychological readiness, self-reported knee function (IKDC score), isokinetic performance (quadriceps and hamstring strength), and muscle strength ratios between athletes who meet return-to-sport (RTS) criteria and those who do not. Psychological readiness will be assessed using the ACL-Return to Sport after Injury (ACL-RSI) scale, while knee function will be evaluated using the IKDC subjective score. Isokinetic testing will assess quadriceps and hamstring strength at various angular velocities. This study aims to provide a more comprehensive understanding of the factors influencing an athlete's ability to return to sport after ACLR, combining both physical and psychological aspects. The results will help optimize rehabilitation strategies by offering a multidimensional approach, considering both physical and psychological factors, to improve recovery protocols for ACL-injured athletes.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

October 8, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

24 days

First QC Date

September 20, 2025

Last Update Submit

September 30, 2025

Conditions

Keywords

ACL InjuryACL ReconstructionPeroneus Longus TendonReturn to SportPsychological ReadinessKnee FunctionIsokinetic Strength TestingHamstring-to-Quadriceps RatioPost-Surgery RehabilitationSports MedicinePhysical Therapy RehabilitationKnee Stabilityperoneus longus graft

Outcome Measures

Primary Outcomes (2)

  • Psychological Readiness to Return to Sport

    Psychological readiness to return to sport measured by the validated Arabic version of the ACL-Return to Sport after Injury (ACL-RSI). Total score 0-100; higher scores indicate greater psychological readiness.

    Up to 9 months post-operative

  • Isokinetic Strength Performance (Quadriceps Strength at Various Velocities)

    This measure evaluates quadriceps strength at 60°/s, 120°/s, and 240°/s using the HUMAC NORM Isokinetic Dynamometer. It assesses peak torque and average power production in both the injured and uninjured limbs.

    Up to 9 months post-operative

Secondary Outcomes (6)

  • Knee Function

    Up to 9 months post-operative

  • Isokinetic Performance (Quadriceps and Hamstring Strength at Different Velocities)

    Up to 9 months post-operative

  • Dynamic Postural Control

    Up to 9 months post-operative

  • Core Muscle Endurance

    Up to 9 months post-operative

  • Limb Symmetry Index (LSI)

    Up to 9 months post-operative

  • +1 more secondary outcomes

Study Arms (2)

Athletes Meeting Return-to-Sport (RTS) Criteria

This group includes athletes who have undergone anterior cruciate ligament reconstruction (ACLR) using a Peroneus Longus tendon graft and meet the return-to-sport (RTS) criteria. These athletes demonstrate psychological readiness, self-reported knee function, and sufficient strength recovery (isokinetic strength at 60°/s, 120°/s, and 240°/s), with an H/Q ratio ≥ 90% and IKDC score ≥ 90. These athletes are eligible to return to their pre-injury sport levels based on the established RTS criteria. They will be assessed for psychological readiness using the ACL-RSI scale, knee function with the IKDC score, and isokinetic strength testing at various velocities.

Athletes Not Meeting Return-to-Sport (RTS) Criteria

This group includes athletes who have undergone ACLR using a Peroneus Longus tendon graft but do not meet the RTS criteria. These athletes may experience insufficient psychological readiness, self-reported knee function, or muscle strength recovery. Specifically, they may have an H/Q ratio below 90%, an IKDC score lower than 90, or fail to achieve adequate isokinetic strength at the required angular velocities (60°/s, 120°/s, 240°/s). These athletes will be assessed using the ACL-RSI scale, IKDC score, and isokinetic strength testing, and the study will explore the factors contributing to their inability to meet RTS criteria.

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of male recreational athletes who have undergone anterior cruciate ligament reconstruction using the Peroneus Longus tendon. These athletes must meet specific criteria to return to sport and will be evaluated for both physical and psychological readiness. Participants will be assessed at least 6 months post-surgery, with both case (RTS) and control (non-RTS) groups based on their ability to return to sport.

You may qualify if:

  • Male recreational athletes aged 18-35 years.
  • Participation in sports that involve deceleration, jumping, cutting, or turning (e.g., basketball, soccer, volleyball).
  • Primary unilateral ACL injury treated with ACL reconstruction using a Peroneus Longus autograft.
  • Single evaluation 6-12 months after ACL reconstruction.
  • Completed a standardized postoperative rehabilitation program for ≥6 months, with near-complete rehabilitation and some level of sport participation.
  • Sufficient knee confidence, no effusion/edema, full knee range of motion, and able to perform all functional tests safely.
  • Able to provide written informed consent.

You may not qualify if:

  • Revision ACL reconstruction.
  • Prior ACL reconstruction on the ipsilateral or contralateral knee.
  • Multi-ligament knee injury.
  • Concomitant meniscal repair or bilateral ACL reconstruction.
  • Knee pain \> 3/10 at evaluation that prevents or impairs testing.
  • Incomplete knee extension or knee flexion \< 110°.
  • Lower-limb fracture or surgery within the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHUC

Cairo, Cairo Governorate, 11865, Egypt

RECRUITING

MeSH Terms

Conditions

Wounds and InjuriesAthletic InjuriesKnee InjuriesAnterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Leg Injuries

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of Physical Therapy

Study Record Dates

First Submitted

September 20, 2025

First Posted

October 1, 2025

Study Start

October 8, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations