NCT07423767

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Anterior Cruciate Ligament (ACL) Tear

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2026-02-14
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2026-02-20
• Last updated: 2026-04-13

Locations

2 sites across 1 country: China