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NOT YET RECRUITING
NCT06621355

A Paradigm Shift in Musculoskeletal Rehabilitation Assessment After ACL Reconstruction Using Near-Infrared Spectroscopy

Sponsor: Universitat de Lleida

View on ClinicalTrials.gov

Summary

This study aims to establish and compare muscle haemodynamic response patterns in physically active subjects with anterior cruciate ligament (ACL) reconstruction, at different time points after surgery, against healthy controls, using 24 non-invasive near-infrared spectroscopy (NIRS) devices simultaneously during a single incremental interval cycling test. Muscle haemodynamics has so far been assessed using at most 2-3 near-infrared spectroscopy devices on isolated muscles and without correlating variables. At the same time, research on musculoskeletal pathologies is limited, and there are no studies that analyse the haemodynamic changes that occur when the anterior cruciate ligament (ACL) is injured and whether these changes last over time. This is a multicentre, observational, case-control, cross-sectional study, approved by the Clinical Research Ethics Committee of the Arnau de Vilanova University Hospital (CEIC-3203), that will include males aged 18-65 years who have undergone ACL reconstruction, divided into three groups: less than 6 months since surgery (ACL1), more than 2 years since surgery with normalised physical activity (ACL2), and a healthy control group with no history of ACL injury. Recruitment has not yet started and is expected to begin in October 2026

Official title: A Paradigm Shift in the Assessment of Musculoskeletal Rehabilitation After Anterior Cruciate Ligament Reconstruction: Protocol for a Multicenter Case-Control Cross-Sectional Study Using Near-Infrared Spectroscopy (HemoNIRS-LCA)

Key Details

Gender

MALE

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

129

Start Date

2026-10-01

Completion Date

2026-12-30

Last Updated

2026-09-10

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Incremental Interval Test on a Cycle Ergometer

Participants perform a single incremental interval test on a cycle ergometer: 4 minutes of exercise followed by 1 minute of rest, at an individual intensity below the anaerobic threshold. All participants begin at the same initial load of 50 watts, increased at the end of each rest minute in steps of 25 watts, until the participant is unable to complete a full interval; this final incomplete interval is also recorded and analysed. During the rest minute, participants must remain completely still, without moving any part of the body; at the end of each 4-minute work period, the assessor counts down so the participant can prepare for the next interval. Throughout the test, 24 near-infrared spectroscopy (NIRS) devices are placed bilaterally over 12 muscle sites: rectus femoris (proximal and distal thirds), vastus medialis, vastus lateralis, biceps femoris (proximal and distal thirds), semitendinosus, gluteus maximus, tibialis anterior, gastrocnemius, medial deltoid, and biceps brachii.

Locations (1)

Espai Físic de Salut Integral (Sant Agustí)

Palma de Mallorca, Balearic Islands, Spain