Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07243535

Fractal vs Isochronous Cueing in Athletes After ACL Reconstruction

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Egas Moniz School of Health & Science

Almada, Monte de Caparica, 2829-511, Portugal

Location status: Recruiting

Location contact

Inês Gomes

CONTACT

[email protected]

About this study

This study will test a laboratory-based intervention using gait trials with sensorimotor synchronization, a common approach in gait rehabilitation aimed at restoring or acutely modifying gait variability. The intervention, called SyncGait, consists of treadmill walking synchronized with visual cues. Following a crossover design, each participant will complete two sessions, one with fractal cueing (FRC) and one with isochronous cueing (ISO), with the order randomized. Each cued trial will last 12 minutes and will be preceded and followed by uncued walking trials. The visual cues will be presented as a moving bar on a screen positioned in front of the treadmill. For the FRC condition, the cues will be individualized to each participant's stride time variability, generated through a fractal algorithm and validated using detrended fluctuation analysis. For the ISO condition, cues will match each participant's average stride time without variability. Participants will be instructed to synchronize heel strikes of the reconstructed limb with the top of the moving bar. The treadmill (Bertec Inc., USA) will record gait data at 1000 Hz. Each session will be conducted individually, supervised by at least two trained team members. A sample size of 36 participants was determined to ensure adequate power (90%) to detect a moderate effect size (ηp² = 0.25) at a 5% significance level, accounting for an anticipated 20% dropout rate. To encourage participation and retention, participants will receive a personalized evaluation report and a free isokinetic assessment within 12 months. Data collection will include both gait and corticospinal outcomes. Gait variability will be analyzed from treadmill force data, focusing on stride intervals and synchronization performance. Corticospinal outcomes will be assessed using transcranial magnetic stimulation (TMS) with a BiStim2 stimulator (Magstim®, UK). Electromyography (Delsys Trigno, AD Instruments, NZ) will be recorded from quadriceps and hamstrings, while knee strength will be assessed with an isokinetic dynamometer (Humac Norm, USA). Standardized electrode placement and contraction protocols will ensure reproducibility. During testing, single- and paired-pulse TMS protocols will be applied at 10% of maximal voluntary contraction. Ten stimuli per condition will be collected, providing reliable estimates of excitability and inhibition. Visual feedback will help participants maintain the required contraction level throughout assessments. Statistical analysis will begin with normality testing (Shapiro-Wilk). Linear mixed models (Time × Cue condition) will be used for primary and secondary outcomes. Post-hoc comparisons will use Bonferroni corrections. Synchronization accuracy will be compared with paired t-tests. Statistical significance will be set at p < 0.05, and analyses will be performed using Jamovi software. This protocol is designed to rigorously test whether fractal cueing can restore healthy gait variability patterns and enhance corticospinal excitability in athletes with ACL reconstruction, compared with conventional isochronous cueing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractal Cueing

Device

Walking synchronized to a visual fractal metronome.

Isochronous Cueing

Device

Walking synchronized to a visual Isochronous metronome.

Primary outcomes

  1. Gait Variability Measured by Fractal Scaling Exponent of inter-stride intervals

    Time frame: Pre- (40 minutes before) and Post- (40 minutes after) -Intervention

    The fractal-scaling exponent, α, of inter-stride intervals (α-ISIs) will be determine by calculating the time between two consecutive heel strikes of the same foot. First, the investigators will identify the heel strike events of the dominant foot. To improve the identification of this event, the signals will be filtered using a 2nd order, zero lag low-pass Butterworth filter with a cutoff frequency of 20 Hz. Then, Detrended Fluctuation Analysis (DFA) will be used to determine the fractal-scaling, an index of complexity. The DFA is a modified random-walk analysis that makes use of a long-range correlated time series. The long-range correlation can be mapped to self-similar calculations through simple integration.

  2. Corticospinal Excitability Measured by Motor Evoked Potential Amplitude

    Time frame: Baseline (Pre) and immediately after the intervention (Post)

    Conducted using Spike2 software (version 10; Cambridge Electronic Design, Cambridge, United Kingdom) and subsequently exported to, MATLAB R2018a (The MathWorks, Natick, Massachusetts, United States) for processing and analysis. Corticospinal Excitability will be quantified as the peak-to-peak amplitude of MEPs elicited by a single-pulse TMS stimulus, with values averaged across 10 trials per participant.

  3. Cortical Silent Period (SP) Duration

    Time frame: Baseline (Pre) and immediately after the intervention (Post)

    Silent period will be calculated as the time from MEP onset to the resumption of voluntary EMG activity, expressed as SP = resumption of voluntary EMG time - MEP onset (58), and averaged across all 10 stimuli.

  4. Intracortical Facilitation (ICF)

    Time frame: Baseline (Pre) and immediately after the intervention (Post)

    ICF will be determined using the same calculation method but with an interstimulus interval of 12 ms (ICF = conditioned MEP / control MEP).

  5. Short-Interval Intracortical Inhibition (SICI)

    Time frame: Baseline (Pre) and immediately after the intervention (Post)

    SICI will be calculated as the ratio between the conditioned MEP elicited with a paired-pulse TMS protocol (interstimulus interval: 3 ms) and a control MEP obtained from AMT assessment, expressed as SICI = conditioned MEP / control MEP.

Secondary outcomes

  1. Magnitude of variability

    Time frame: Pre- (40 minutes before) and Post- (40 minutes after) -Intervention

    Calculate the coefficient of variation of inter-stride intervals, representing the magnitude of variability.

  2. Synchronization Accuracy

    Time frame: During Intervention

    Asynchronies (ASYNC), i.e., the time difference between the heel strikes and the cues, expressed in milliseconds. This will be used to ensure that differences at the primary outcome are not the result of different synchronization performances. A negative value of ASYNC indicates that the heel strike occurred before the cue. The ASYNC provides information regarding the strategies used and the performance of the synching processes, serving as a control parameter to reliably interpret our results in terms of gait complex.

Other outcomes

  1. Demographic characterization of the sample by Lysholm Knee Score (LKS).

    Time frame: At the beginning of the first session (Day 1)

    The LKS show good internal consistency (Cronbach's α = 0.802) and high test-retest reliability (ICC = 0.859). The LKS consists of 8 items with 3 to 6 closed-response options, assessing knee function aspects such as pain, swelling, locking, and instability. The scale is completed in ≈5 minutes, with higher scores indicating better knee function.

  2. Demographic characterization of the sample by Tegner Activity Scale (TAS)

    Time frame: At the beginning of the first session (Day 1)

    The TAS show good internal consistency (Cronbach's α = 0.802) and high test-retest reliability (ICC = 0.972). The TAS comprises a single item with 11 activity levels (0-10), reflecting increasing physical demand. The scale is completed in ≈2 minutes, with higher scores indicating greater physical activity levels (TAS).

  3. Demographic characterization of the sample by Tampa Scale of Kinesiophobia (TSK)

    Time frame: At the beginning of the first session (Day 1)

    The TSK consists of 13 items rated on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), with a total score ranging from 13 to 52, where higher scores indicate greater kinesiophobia. It required 4 to 6 minutes to complete the instrument and demonstrated good internal consistency (α = 0.82) and test-retest reliability (ICC = 0.99), confirming its reliability for assessing kinesiophobia.

Study contacts

Contact information is provided by the study sponsor or research team.

Catarina S Pino, MSC Student

CONTACT

[email protected]

(+351) 937 780 194

Inês D Ribeiro, MSC Student

CONTACT

[email protected]

(+351) 964 544 607

Sponsors and collaborators

Lead sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL

Other

Registry information

Official study title

Comparison Between a Session of Walking Synchronized to Fractal- VS Isochronous-Based Cues on Gait Variability and Corticospinal Measures in Athletes With a Reconstructed Anterior Cruciate Ligament: A Crossover Randomized Controlled Trial

Acronym: SyncGait

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.