Preoperative cognitive-behavioral program to reduce fear of movement and improve function after an ACL tear
Official title: Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction
Run by Peking University Third Hospital · NCT07423767 · Data updated 2026-11-12
This project tests whether a short pre-surgery cognitive-behavioral program can reduce fear of movement and improve walking, jogging, and balance in adults 18–45 with a recent ACL tear scheduled for reconstruction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 2 sites (Beijing, None Selected and 1 other locations) |
| Status | Recruiting |
| Started | February 14, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07423767 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–45 with a first-time ACL rupture within the past 3 months, planned for reconstruction at Peking University Third Hospital, with basic daily activities restored and only minimal other knee ligament injury are ideal candidates.
✕Probably not a fit
Patients younger than 18 or older than 45, with ACL rupture older than 3 months, significant concurrent ligament injuries, or BMI <18.5 or >35 kg/m² are ineligible and unlikely to benefit from this preoperative program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, assessor-blinded trial enrolling 44 adults with a primary ACL rupture scheduled for reconstruction. Participants undergo baseline testing including questionnaires (TSK), motor performance (gait, jogging, postural stability), and EEG, then are randomly assigned to usual care or to usual care plus a single 60-minute CBT-based in-person session and 3–4 weekly phone follow-ups. All participants repeat the full assessment on the day of hospital admission for surgery, and the primary outcome is change in kinesiophobia (TSK) from baseline to pre-op. Secondary outcomes include changes in motor performance metrics and EEG measures to explore brain-psychology-motor interactions.
Why it matters
Potential benefit: If successful, the intervention could lower fear of movement before surgery and improve preoperative movement patterns, which may simplify postoperative rehab and speed recovery.
How similar studies have gone: Psychological interventions like CBT have shown benefit for fear-avoidance in other musculoskeletal conditions, but applying a brief preoperative CBT protocol with EEG and motor metrics for ACL reconstruction is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 to 45 years with a diagnosis of anterior cruciate ligament (ACL) rupture. 2. ACL rupture within 3 months prior to enrollment. 3. First-time ACL rupture with a scheduled reconstruction surgery at this institution. 4. The affected knee shows no significant redness, swelling, pain, or inflammation, with basic activities of daily living restored. 5. No injury or only mild (grade I) injury to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament. Exclusion Criteria: 1. Body mass index (BMI) less than 18.5 or greater than 35 kg/m². 2. Age older than 45 years or younger than 18 years. 3. ACL rupture with a duration exceeding 3 months. 4. 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). 5. Concurrent severe meniscal tear. 6. History of prior knee surgery (e.g., meniscal repair, ligament reconstruction, joint replacement, arthroscopic debridement). 7. Presence of other significant knee pathologies, such as: knee osteoarthritis, knee tumor, rheumatoid arthritis, tuberculosis, or active infectious/inflammatory diseases of the knee. 8. Concurrent fracture, dislocation, or other osseous injuries involving the knee. 9. Unwillingness to receive the treatment protocol of this study.
Where it's running
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Peking university third hospital, Beijing,
Beijing, None Selected, China Recruiting -
Peking university third hospital, Beijing,
Beijing, China Not yet recruiting
Study contacts
- Study coordinator: Shuang Ren, PhD
- Email: xixishuang123@126.com
- Phone: 17610252992
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.