An interventional study of Cognitive-Behavioral Intervention and Control group in Anterior Cruciate Ligament (ACL) Tear, sponsored by Peking University Third Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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.
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.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 44 is below the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following the initial outpatient visit, participants in the experimental group will receive: 1. A Single Face-to-Face Psychological Guidance Session (Encouraging Attempts at Pain-Free Activity), which includes: Encouraged training within a normal range of motion. Guided practice of normal walking and slow jogging without the use of crutches or a functional knee brace. 2. Weekly Telephone Follow-ups (for a duration of 3-4 weeks), with each call designed to: Provide ongoing psychological support. Inquire about the status of the knee joint. Encourage the continued practice of normal activities without crutches or brace.
Other: Cognitive-Behavioral Intervention
Participants in this group will receive standard preoperative care only during the waiting period before surgery. This includes routine medical consultations and general preoperative instructions as per the hospital's standard clinical pathway, without any additional structured psychological intervention provided by the study protocol.
Other: Control group
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.
This group receives standard preoperative care only (no psychological intervention). They undergo identical outcome assessments at the same time points as the intervention group.
The Tampa Scale for Kinesiophobia (TSK)-11
The Tampa Scale for Kinesiophobia (TSK) is a validated, patient-reported questionnaire designed to assess the fear of movement and (re)injury. The 11-item version (TSK-11) used in this study is a widely adopted shortened form with robust psychometric properties. It consists of 11 statements (e.g., "I'm afraid that I might injure myself if I exercise") to which participants indicate their level of agreement on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The total score is calculated by summing the responses to all 11 items, resulting in a possible score range from 11 to 44. A higher total score indicates a greater degree of kinesiophobia.
Time frame: 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
Electroencephalography is a non-invasive neurophysiological technique used to record and measure the brain's spontaneous electrical activity from the scalp.
Time frame: 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.
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Jun 2027, 15 months after the start.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's planned 15 months is below that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
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