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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive-Behavioral Intervention

    Other intervention

    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 intervention

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

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Cognitive Behavioral Intervention GroupExperimental treatment 1 intervention
Group B: No Intervention: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.

Secondary outcomes

Other outcomes

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