Recovery of Donor Ankle Sensorimotor Function Following Anterior Cruciate Ligament Reconstruction Using Peroneus Longus Tendon Autograft: A Prospective Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Mean Center of Pressure Velocity During Single-Leg Balance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 55 years.
- •Unilateral primary anterior cruciate ligament tear confirmed by clinical examination and magnetic resonance imaging.
- •Primary anterior cruciate ligament reconstruction performed using a peroneus longus tendon autograft.
- •Able and willing to attend the postoperative assessments at 6-8 weeks, 3 months, and 6 months.
- •Written informed consent provided before study participation.
排除标准
- •Multiligament knee injury.
- •Previous surgery on the index knee or donor ankle.
- •Pre-existing ankle instability or major foot or ankle pathology.
- •Neurological or neuromuscular disease.
- •Inflammatory or systemic disease that may affect the assessments.
- •Major lower-extremity deformity that may affect the assessments.
- •Unable to complete the postoperative rehabilitation program or scheduled follow-up assessments.
研究组 & 干预措施
Peroneus Longus Tendon Autograft ACLR Cohort
Adults after primary unilateral ACL reconstruction using a peroneus longus tendon autograft. Participants will undergo observational assessments at postoperative 6-8 weeks, 3 months, and 6 months. Donor-limb measures will be compared with measurements from the contralateral non-donor limb. No intervention is assigned by the study.
干预措施: Anterior Cruciate Ligament Reconstruction Using a Peroneus Longus Tendon Autograft (Procedure)
结局指标
主要结局
Change in Mean Center of Pressure Velocity During Single-Leg Balance
时间窗: 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.
次要结局
- Change in CoP Path Length During Single-Leg Balance(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in CoP Ellipse Area During Single-Leg Balance(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Mean CoP Velocity During Double-Leg Balance(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in CoP Path Length During Double-Leg Balance(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in CoP Ellipse Area During Double-Leg Balance(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Mean Normalized Peroneus Longus RMS Amplitude During Single-Leg Heel Rise(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Peak Normalized Peroneus Longus RMS Amplitude During Single-Leg Heel Rise(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Mean Normalized Peroneus Longus RMS Amplitude During Incline Heel Rise(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Peak Normalized Peroneus Longus RMS Amplitude During Incline Heel Rise(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Ankle Joint Position Sense Absolute Error(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Self-Selected Gait Speed(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Gait Cadence(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Step Length(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Gait Symmetry Index(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Pelvic Tilt During Gait(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in Pelvic Obliquity During Gait(Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in FAAM Activities of Daily Living Subscale(Preoperative, Postoperative 6-8 weeks, 3 months, and 6 months)
- Change in FAAM Sports Subscale(Preoperative, Postoperative 6-8 weeks, 3 months, and 6 months)
研究者
Dudu Özdemir
PhD Candidate, Department of Physiotherapy and Rehabilitation
Gazi University