Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Sports Health Unit
Çankaya, Ankara, 06490, Turkey (Türkiye)
NCT Number: NCT07762989
This prospective longitudinal observational cohort study will characterize recovery of donor-ankle sensorimotor function in adults who have undergone primary anterior cruciate ligament reconstruction using a peroneus longus tendon autograft. Twenty participants aged 18 to 55 years will be evaluated at postoperative 6-8 weeks, 3 months, and 6 months. The donor limb and the contralateral non-donor limb will be compared using surface electromyography of the peroneus longus, force-platform measures of postural control, inertial-sensor gait analysis, active ankle joint-position sense testing, and clinical and patient-reported foot and ankle function measures. The study does not assign the surgical procedure or rehabilitation treatment.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Observational
Çankaya, Ankara, 06490, Turkey (Türkiye)
Peroneus longus tendon autograft is used as an alternative graft source for anterior cruciate ligament reconstruction, but the longitudinal course of donor-site sensorimotor recovery has not been sufficiently described with objective measures. This study is designed to examine within-participant changes over time and differences between the donor and contralateral non-donor limbs.
Eligible participants who underwent primary unilateral anterior cruciate ligament reconstruction with a peroneus longus tendon autograft at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital or Halil Şıvgın Çubuk State Hospital and who are referred to the Sports Health Unit of Gazi University will be followed at postoperative 6-8 weeks, 3 months, and 6 months. No graft type, surgery, or rehabilitation intervention is assigned by the investigators.
At each assessment, peroneus longus activation will be recorded during single-leg heel-rise and medially inclined heel-rise tasks using surface electromyography and normalized to a session-specific maximal voluntary isometric contraction. Postural control will be assessed with KFORCE Plates during double-leg and single-leg balance tasks. Spatiotemporal gait and pelvic kinematics will be recorded with the G-Walk inertial sensor system. Active ankle joint-position sense will be assessed on a Cybex NORM dynamometer using a 15-degree eversion target. Foot and ankle function will be assessed using the Foot and Ankle Ability Measure.
The primary analysis will examine time, limb, and time-by-limb effects across the three postoperative assessments. Parametric data will be analyzed using two-way repeated-measures analysis of variance, with nonparametric alternatives used when assumptions are not met. The planned enrollment is 20 participants, allowing for approximately 20% attrition from the minimum required sample of 16 completers.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants undergo primary anterior cruciate ligament reconstruction using a peroneus longus tendon autograft as part of their routine clinical care. The graft choice and surgical procedure are determined by the treating orthopedic surgeon independently of study participation. The study does not assign or modify the graft choice, surgical technique, or postoperative rehabilitation. Participants receive routine postoperative rehabilitation according to their clinical needs, while donor-ankle sensorimotor recovery is assessed prospectively at 6-8 weeks, 3 months, and 6 months after surgery.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Mean center of pressure (CoP) velocity during a 10-second single-leg stance, assessed separately with eyes open and eyes closed on KFORCE Plates. Each limb will be tested in three trials, and the mean for each condition will be used. Values are expressed in millimeters per second (mm/s); lower values indicate less postural sway. Change from the postoperative 6-8-week assessment to 3 and 6 months and donor-versus-contralateral limb differences will be evaluated.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Total CoP path length during a 10-second single-leg stance with eyes open and eyes closed on KFORCE Plates, averaged across three valid trials for each limb and condition. Unit: millimeters (mm); lower values indicate less sway.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Ellipse area of CoP excursion during a 10-second single-leg stance with eyes open and eyes closed on KFORCE Plates, averaged across three valid trials. Unit: square millimeters (mm²); lower values indicate less sway area.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Mean CoP velocity during 30-second double-leg quiet stance with eyes open and eyes closed on KFORCE Plates, averaged across three trials per condition. Unit: millimeters per second (mm/s).
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Total CoP path length during 30-second double-leg quiet stance with eyes open and eyes closed on KFORCE Plates, averaged across three trials per condition. Unit: millimeters (mm).
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Ellipse area of CoP excursion during 30-second double-leg quiet stance with eyes open and eyes closed on KFORCE Plates, averaged across three trials per condition. Unit: square millimeters (mm²).
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Mean root-mean-square surface EMG amplitude of the peroneus longus during the concentric, isometric, and eccentric phases of a metronome-paced single-leg heel rise. Each phase is reported separately as a percentage of session-specific maximal voluntary isometric contraction (%MVIC), averaged across three repetitions for each limb.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Peak root-mean-square surface EMG amplitude during the concentric, isometric, and eccentric phases of a single-leg heel rise. Each phase is reported separately as %MVIC and averaged across three repetitions for each limb.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Mean root-mean-square surface EMG amplitude during the concentric, isometric, and eccentric phases of a single-leg heel rise on a rigid platform with approximately 30 degrees of medial inclination. Each phase is reported separately as %MVIC and averaged across three repetitions for each limb.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Peak root-mean-square surface EMG amplitude during the concentric, isometric, and eccentric phases of the medially inclined single-leg heel-rise task. Each phase is reported separately as %MVIC and averaged across three repetitions for each limb.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Absolute difference between the 15-degree eversion target and the angle reproduced by the participant during active joint-position sense testing with eyes closed on a Cybex NORM dynamometer. Each limb will be evaluated separately. Unit: degrees (°); lower values indicate greater position-sense accuracy.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Walking speed recorded with the G-Walk inertial sensor during self-selected walking over an approximately 10-meter walkway. The middle portion of the walk will be analyzed and three trials will be averaged. Unit: meters per second (m/s).
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Cadence recorded with the G-Walk inertial sensor during self-selected walking, averaged across three trials. Unit: steps per minute.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Step length recorded with the G-Walk inertial sensor during self-selected walking, averaged across three trials. Unit: meters (m).
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Between-limb gait symmetry index derived from G-Walk spatiotemporal data. Unit: percent (%); values closer to the device-defined symmetry reference indicate greater symmetry.
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Sagittal-plane pelvic tilt measured by the G-Walk inertial sensor during self-selected walking, averaged across three trials. Unit: degrees (°).
Time frame: Postoperative 6-8 weeks, 3 months, and 6 months
Frontal-plane pelvic obliquity measured by the G-Walk inertial sensor during self-selected walking, averaged across three trials. Unit: degrees (°).
Time frame: Preoperative, Postoperative 6-8 weeks, 3 months, and 6 months
Foot and Ankle Ability Measure Activities of Daily Living subscale, transformed to a 0%-100% score. Higher percentages indicate better self-reported function.
Time frame: Preoperative, Postoperative 6-8 weeks, 3 months, and 6 months
Foot and Ankle Ability Measure Sports subscale, transformed to a 0%-100% score. Higher percentages indicate better self-reported sport-related function.
Contact information is provided by the study sponsor or research team.
Gazi University
Other
Recovery of Donor Ankle Sensorimotor Function Following Anterior Cruciate Ligament Reconstruction Using Peroneus Longus Tendon Autograft: A Prospective Longitudinal Study
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