NCT07297511

Brief Summary

Anterior cruciate ligament (ACL) injury is a common sports-related injury, particularly in sports that require extensive jumping and cutting movements. Although anterior cruciate ligament reconstruction (ACLR) surgery can restore knee stability, many athletes still face the risk of re-injury after returning to competition.Current return-to-play assessment relies primarily on single-plane horizontal hop tests and symmetry indices (LSI ≥ 90%); however, an increasing body of research suggests that these tests may not comprehensively reflect functional deficits in the vertical plane, repeated hopping, or high-intensity sport-specific activities.This study hypothesizes that incorporating multiple vertical jump tests-including single-leg vertical jumps and 10-second repeated vertical jumps-combined with advanced force plate analytics (such as Reactive Strength Index \[RSI\] and Time to Stabilization \[TTS\])-can more sensitively reveal residual neuromuscular control deficits following surgery. This approach would provide evidence-based guidance for return-to-play decision-making, thereby improving athletes' long-term athletic performance and safety.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 29, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

December 22, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

December 9, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

ACL reconstructionvertical jump testreturn to play

Outcome Measures

Primary Outcomes (1)

  • Limb asymmetry index,LSI

    Limb Symmetry Index (LSI) calculated as (\|Uninvolved limb value - Involved limb value\| / (Uninvolved limb value + Involved limb value)) × 100% for each of the four jump tasks: Single-Legged Hop for Distance (SHD), Crossover Hop for Distance (CHD), Single-Legged Vertical Countermovement Jump (SLVJ), and 10-Second Repeated Single-Legged Vertical Jump (SLVJs). LSI values will be compared between ACLR athletes and healthy controls to determine whether vertical jump protocols reveal greater limb asymmetries than traditional horizontal hop tests. Primary analysis will examine whether LSI differences in vertical jump tasks are statistically significantly lower (indicating greater asymmetry) than horizontal hop tasks, revealing residual neuromuscular deficits not detected by conventional return-to-play assessment.

    At baseline (single testing session; no longitudinal follow-up)

Secondary Outcomes (5)

  • Modified Reactive Strength Index

    At baseline (single testing session; no longitudinal follow-up)

  • Time to Stabilization (seconds)

    At baseline (single testing session; no longitudinal follow-up)

  • Single-Legged Hop for Distance (centimeter)

    At baseline (single testing session; no longitudinal follow-up)

  • Crossover Hop for Distance (centimeter)

    At baseline (single testing session; no longitudinal follow-up)

  • Jump Height(meter)

    At baseline (single testing session; no longitudinal follow-up)

Study Arms (2)

Health: Control group

The group include athletes with no lower limbs injury.Participants must be aged 18-35 years and must be elite athletes who have competed in national-level competitions.

ACL reconstruction

Participants must be aged 18-35 years with unilateral ACL rupture confirmed by MRI, Lachman test grade ≥2, and reconstruction using hamstring or gracilis autograft with at least 6 months post-operative. Participants must have completed rehabilitation with clearance from an orthopedic surgeon or physical therapist, demonstrate no other lower extremity injuries, and have no contralateral lower limb injury within the past 3 months. Additionally, quadriceps strength symmetry index must be ≥90%, and participants must be elite athletes who have competed in national-level competitions.

Eligibility Criteria

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

The study population consists of two distinct groups: (1) ACLR athletes: elite athletes aged 18-35 years who have undergone unilateral anterior cruciate ligament reconstruction using hamstring or gracilis autograft with a minimum of 6 months post-operative. These participants will be recruited from orthopedic clinics, sports medicine centers, and rehabilitation facilities in the region. (2) Healthy controls: age, sex, and athletic-level matched individuals aged 18-35 years with no history of lower extremity injuries, recruited from local athletic facilities, university sports programs, and community sports organizations. Both groups must have elite athlete status, defined as prior participation in national-level sports competitions. The ACLR group represents athletes in the late rehabilitation phase preparing for return-to-play, while the healthy control group serves as a reference for normal biomechanical performance.

You may qualify if:

  • Age 18-35 years
  • Unilateral anterior cruciate ligament (ACL) rupture confirmed by magnetic resonance imaging (MRI)
  • Positive Lachman test grade ≥2 pre-operatively
  • Anterior cruciate ligament reconstruction (ACLR) using hamstring or gracilis autograft
  • Post-operative time ≥6 months
  • Completed rehabilitation program with clearance from orthopedic surgeon or physical therapist
  • Quadriceps strength symmetry index ≥90%
  • Elite athlete status (prior participation in national-level competitions)

You may not qualify if:

  • Other lower extremity injuries or pathologies (including other knee ligament injuries)
  • Contralateral lower limb injury within the past 3 months
  • Quadriceps strength symmetry index \<90%
  • Non-elite athlete status (no prior national-level competition participation)
  • Incomplete rehabilitation or lack of medical clearance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Taiwan

Location

Study Officials

  • GUO L Y Professor and Dean of college, Ph.D.

    Department of Sports Science, Kaohsiung Medical University, Taiwan

    STUDY CHAIR

Central Study Contacts

Teng C Y Kaohsiung Medical University, Bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

December 29, 2025

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

December 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that underlie the main published results, including demographic characteristics and biomechanical outcome measures (e.g., jump height, limb symmetry index, RSI, TTS, and impulse), will be shared with qualified researchers upon reasonable request, after approval of a data use agreement and in accordance with applicable ethical and regulatory requirements.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
De-identified individual participate data (IPD) and supporting information will be available starting 2 years after the publication of the primary study results and will remain accessible for 5 years.
Access Criteria
The related supporting documents will only be made available to qualified researchers affiliated with academic institutions, medical organizations, or public health agencies. Applicants must submit a detailed research proposal and ethical approval documents, and access will be granted only upon approval.

Locations