Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Ante… (NCT07423767) | Clinical Trial Compass
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Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction
China44 participantsStarted 2026-02-14
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
The Tampa Scale for Kinesiophobia (TSK)-11
Timeframe: 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.
2
Electroencephalography
Timeframe: 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.
✕. 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.