Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction

Обзор

This study aims to systematically elucidate the integrative effects of psychological rehabilitation on the "brain-psychology-motor" triad in patients with anterior cruciate ligament (ACL) rupture. We plan to recruit 44 patients (aged 18-45) diagnosed with ACL rupture and scheduled for reconstruction surgery at Peking University Third Hospital, who will be randomly assigned to two groups. Through synchronous acquisition of questionnaire scores, motor performance data (gait, jogging, postural stability), and central neural activity (EEG), this research seeks to establish a foundation for developing neuroscience evidence-based, precision rehabilitation strategies.

Подробное описание

1. Study Design This is a prospective, randomized controlled trial with assessor blinding, evaluating a preoperative psychological intervention for ACL reconstruction patients. 2. Procedures After providing consent at the first clinic visit, all participants complete a baseline assessment (T0) including motor tests (gait, jogging, balance), EEG, and questionnaires (e.g., TSK for kinesiophobia). They are then randomly assigned to the Control or Intervention group.

Control Group: Receives standard preoperative care only.

Intervention Group: Receives standard care plus:

One In-Person Session: A 60-minute CBT-based session after T0, focusing on psychoeducation and guided, encouraged practice of pain-free movements (normal ROM, walking/jogging without crutches/brace).

Weekly Phone Follow-ups (3-4 weeks): To provide support, monitor the knee, and encourage continued practice of unassisted activities. 3. Final Assessment All participants repeat the full assessment battery (T1) on the day of hospital admission for surgery. 4. Outcomes The primary outcome is the change in kinesiophobia (TSK score) from T0 to T1. Secondary outcomes include changes in motor performance, EEG activity, and other patient-reported measures.

Вмешательства

• Другое Cognitive-Behavioral Intervention
  This is a preoperative psychological intervention that uniquely combines a single in-person session (featuring guided practice of normal movement without assistive devices) with weekly phone support for 3-4 weeks, specifically designed to reduce kinesiophobia before anterior cruciate ligament reconstruction surgery.
• Другое Control group
  This group receives standard preoperative care only (no psychological intervention). They undergo identical outcome assessments at the same time points as the intervention group.

Первичные конечные точки

• The Tampa Scale for Kinesiophobia (TSK)-11 [Срок оценки: The intervention group is assessed at baseline (T0, post-initial visit), post-intervention (T1, 3 weeks), and at 12 (T2), and 24 (T3) weeks post-surgery.]
• Electroencephalography [Срок оценки: This study follows a parallel assessment schedule. The intervention group is assessed at baseline (T0, post-initial visit), post-intervention (T1, 3 weeks), and at 12 (T2), and 24 (T3) weeks post-surgery.]

Критерии участия

Критерии включения

• Patients aged 18 to 45 years with a diagnosis of anterior cruciate ligament (ACL) rupture.
• ACL rupture within 3 months prior to enrollment.
• First-time ACL rupture with a scheduled reconstruction surgery at this institution.
• The affected knee shows no significant redness, swelling, pain, or inflammation, with basic activities of daily living restored.
• No injury or only mild (grade I) injury to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament.

Критерии исключения

• Body mass index (BMI) less than 18.5 or greater than 35 kg/m².
• Age older than 45 years or younger than 18 years.
• ACL rupture with a duration exceeding 3 months.
• Concurrent severe injury (greater than grade I sprain) to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament. (Note: Grade II indicates partial tear with ligament thickening, laxity, and partial fiber disruption; Grade III indicates complete rupture).
• Concurrent severe meniscal tear.
• History of prior knee surgery (e.g., meniscal repair, ligament reconstruction, joint replacement, arthroscopic debridement).
• Presence of other significant knee pathologies, such as: knee osteoarthritis, knee tumor, rheumatoid arthritis, tuberculosis, or active infectious/inflammatory diseases of the knee.
• Concurrent fracture, dislocation, or other osseous injuries involving the knee.
• Unwillingness to receive the treatment protocol of this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Peking university third hospital, Beijing, — Пекин
• Peking university third hospital, Beijing, — Пекин

Идентификаторы

NCT: NCT07423767 · M20251095

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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