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NCT Number: NCT07423767

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

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.

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Key information

Conditions

Anterior Cruciate Ligament (ACL) Tear Lacerations Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking university third hospital, Beijing,, Beijing, None Selected, China

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About this study

  • Study Design This is a prospective, randomized controlled trial with assessor blinding, evaluating a preoperative psychological intervention for ACL reconstruction patients.
  • 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.

  • Final Assessment All participants repeat the full assessment battery (T1) on the day of hospital admission for surgery.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The Tampa Scale for Kinesiophobia (TSK)-11

    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.

    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.

  2. Electroencephalography

    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.

    Electroencephalography is a non-invasive neurophysiological technique used to record and measure the brain's spontaneous electrical activity from the scalp.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuang Ren, PhD

CONTACT

[email protected]

17610252992

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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