Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- The Tampa Scale for Kinesiophobia (TSK)-11
研究概览
简要总结
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.
详细描述
- 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. 3. Final Assessment All participants repeat the full assessment battery (T1) on the day of hospital admission for surgery. 4. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
No Intervention: Control Group
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.
干预措施: Control group (Other)
Cognitive Behavioral Intervention Group
Following the initial outpatient visit, participants in the experimental group will receive:
- 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.
干预措施: Cognitive-Behavioral Intervention (Other)
结局指标
主要结局
The Tampa Scale for Kinesiophobia (TSK)-11
时间窗: 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.
Electroencephalography
时间窗: 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.
次要结局
未报告次要终点