NCT07243535 Fractal vs Isochronous Cueing in Athletes After ACL Reconstruction
| NCT ID | NCT07243535 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Egas Moniz - Cooperativa de Ensino Superior, CRL |
| Condition | Anterior Cruciate Ligament Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-10-03 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Anterior cruciate ligament (ACL) injuries are among the most prevalent and functionally limiting knee injuries in sports, particularly those that involve pivoting movements. Despite advancements in surgical reconstruction and physical rehabilitation, many athletes continue to exhibit persistent motor control deficits and increased gait variability, both of which are closely linked to a heightened risk of re-injury and long-term joint degeneration. These deficits arise from biomechanical impairments and disrupt proprioceptive input that requires cortical reorganization, contributing to maladaptive neuroplasticity. However, conventional rehabilitation strategies often overlook this neural dimension. Recent findings emphasize the importance of fostering motor variability and promoting neuroplasticity through external focus strategies, including sensorimotor synchronization. While isochronous cues, an invariant stimulus, are commonly used, they do not reflect the natural fluctuations of healthy gait and may reduce its complexity. Fractal-based cues, in contrast, introduce structured variability resembling the natural dynamics of locomotion and have been shown to restore gait complexity in clinical populations. However, no study has yet explored their acute effects on gait variability and corticospinal function following ACL reconstruction (ACLR). This crossover randomized controlled trial aims to compare the acute effects of a single session of treadmill walking synchronized to either fractal or isochronous-based visual cues on gait variability and corticospinal measures in athletes with ACLR. The investigators hypothesize that fractal-based cueing will acutely restore gait variability and enhance corticospinal excitability, evidenced by increased corticospinal excitability and intracortical facilitation, and reduced short-interval intracortical inhibition, thus promoting adaptive neuroplasticity. Conversely, isochronous cueing is expected to maintain or decrease gait complexity without improving corticospinal measures. This study may provide insights that could be highly valuable as a way to promote neuroplasticity and optimize gait rehabilitation after ACLR, also allowing an objective quantification and aiming to restore variability to levels close to those observed in healthy individuals, thus contributing to reducing the re-injury rate.
Eligibility Criteria
Inclusion Criteria: * Undergone unilateral ACL reconstruction less than 2 years ago; * Have medical release for the full load on the injury limb for at least 2 weeks; * Be independently pain-free walking; * Being sports athletes according to an athlete description: Training regularly to improve performance, actively participating in competitions or formally registering in a sports federation or association; * Must be able to understand and perform the requested task. Exclusion Criteria: * Participants with previous surgery on either knee; * Those with more than 3 months between ACL injury and surgery; * More than 2 weeks between surgery and the start of physical therapy; * Had another musculoskeletal injury in the lower limb within the past 6 months; * Another musculoskeletal surgery within the past 18 months; * Participants with a history of movement system pathologies, such as nervous system, cardiovascular, pulmonary, integumentary, or endocrine conditions; * Participants with vestibular or somatosensory system pathologies or visual impairments limiting their ability to see the metronome required for the task; * Use of medications that could affect locomotion and balance.
Contact & Investigator
João R Vaz, PhD
STUDY DIRECTOR
Egas Moniz school of Health & Science
Frequently Asked Questions
Who can join the NCT07243535 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 35 Years, studying Anterior Cruciate Ligament Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07243535 currently recruiting?
Yes, NCT07243535 is actively recruiting participants. Contact the research team at 115360@alunos.egasmoniz.edu.pt for enrollment information.
Where is the NCT07243535 trial being conducted?
This trial is being conducted at Almada, Portugal.
Who is sponsoring the NCT07243535 clinical trial?
NCT07243535 is sponsored by Egas Moniz - Cooperativa de Ensino Superior, CRL. The principal investigator is João R Vaz, PhD at Egas Moniz school of Health & Science. The trial plans to enroll 36 participants.