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

NCT07423767 | Recruiting

• 1 other identifier: M20251095
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anterior Cruciate Ligament (ACL) Tear

Keywords

Anterior cruciate ligament; Cognitive-Behavioral Intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

Study Arms (2)

Cognitive Behavioral Intervention Group

EXPERIMENTAL

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

No Intervention: Control Group

OTHER

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

Interventions

Cognitive-Behavioral Intervention OTHER

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.

Cognitive Behavioral Intervention Group

Control group OTHER

This group receives standard preoperative care only (no psychological intervention). They undergo identical outcome assessments at the same time points as the intervention group.

No Intervention: Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Concurrent severe meniscal tear.
• 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.
• Unwillingness to receive the treatment protocol of this study.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (2)

Peking university third hospital, Beijing,

Beijing, None Selected, 100191, China

RECRUITING

Peking university third hospital, Beijing,

Beijing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lacerations

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Shuang Ren, PhD

CONTACT

17610252992; xixishuang123@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: February 14, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)