Actively Recruiting
Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction
Led by Peking University Third Hospital · Updated on 2026-04-13
44
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combined effects of psychological rehabilitation on brain activity, psychological state, and motor function in patients with anterior cruciate ligament (ACL) rupture. This randomized controlled trial involves 44 patients aged 18 to 45 years, all scheduled for ACL reconstruction surgery. The study aims to gather neuroscience evidence to help develop precise rehabilitation strategies by measuring questionnaire scores, motor performance (including gait, jogging, and postural stability), and brain activity using EEG. Participants are randomly assigned to either a cognitive-behavioral intervention group or a control group. The intervention group receives standard preoperative care plus one 60-minute in-person cognitive-behavioral therapy (CBT) session focused on pain-free movement practice and weekly phone follow-ups for 3 to 4 weeks to provide psychological support and encourage continued knee activity without assistive devices. The control group receives only standard preoperative care without additional psychological intervention. Throughout the study, participants complete baseline assessments and repeat them on the day of hospital admission for surgery. These assessments include motor tests, EEG, and questionnaires such as the Tampa Scale for Kinesiophobia (TSK). Researchers will measure changes in kinesiophobia, motor performance, and brain activity over time. The study also includes follow-ups at 12 and 24 weeks post-surgery to monitor longer-term effects and safety. Total participation covers the period from initial assessment through post-surgery follow-up.
CONDITIONS
Brief Title
Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 45 years with a diagnosis of anterior cruciate ligament (ACL) rupture.
- ACL rupture occurred within 3 months before enrollment.
- First-time ACL rupture with planned reconstruction surgery at this hospital.
- The affected knee shows no significant redness, swelling, pain, or inflammation, and basic daily activities are restored.
- No injury or only mild (grade I) injury to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament.
You will not qualify if you...
- Body mass index (BMI) less than 18.5 or greater than 35 kg/m².
- Age younger than 18 years or older than 45 years.
- ACL rupture lasting more than 3 months.
- Severe injury (greater than grade I sprain) to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament.
- Severe meniscal tear.
- History of prior knee surgery such as meniscal repair, ligament reconstruction, joint replacement, or arthroscopic debridement.
- Other significant knee conditions like osteoarthritis, knee tumor, rheumatoid arthritis, tuberculosis, or active infections/inflammation.
- Concurrent fracture, dislocation, or other bone injuries involving the knee.
- Unwillingness to follow the study treatment protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 4 weeks
Participants complete baseline assessments including motor tests, EEG, and questionnaires, then are randomized to groups. The intervention group receives a single 60-minute cognitive-behavioral therapy session focusing on guided practice of pain-free movements, followed by weekly phone follow-ups to support and encourage activity.
1 in-person session and weekly phone calls for 3 to 4 weeks
Duration - 1 day
Participants undergo anterior cruciate ligament reconstruction surgery after completing preoperative assessments and interventions.
1 visit (hospital admission for surgery)
Trial Site Locations
Total: 2 locations
1
Peking university third hospital, Beijing,
Beijing, None Selected, China, 100191
Actively Recruiting
2
Peking university third hospital, Beijing,
Beijing, China
Not Yet Recruiting
Research Team
S
Shuang Ren, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here