Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:51 AM
Study NCT ID:
NCT07423767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D022125', 'term': 'Lacerations'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Tampa Scale for Kinesiophobia (TSK)-11', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Electroencephalography', 'timeFrame': '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.', 'description': "Electroencephalography is a non-invasive neurophysiological technique used to record and measure the brain's spontaneous electrical activity from the scalp."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior cruciate ligament; Cognitive-Behavioral Intervention'], 'conditions': ['Anterior Cruciate Ligament (ACL) Tear']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '1. Study Design This is a prospective, randomized controlled trial with assessor blinding, evaluating a preoperative psychological intervention for ACL reconstruction patients.\n2. 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.\n\n Control Group: Receives standard preoperative care only.\n\n Intervention Group: Receives standard care plus:\n\n 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).\n\n Weekly Phone Follow-ups (3-4 weeks): To provide support, monitor the knee, and encourage continued practice of unassisted activities.\n3. Final Assessment All participants repeat the full assessment battery (T1) on the day of hospital admission for surgery.\n4. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 to 45 years with a diagnosis of anterior cruciate ligament (ACL) rupture.\n2. ACL rupture within 3 months prior to enrollment.\n3. First-time ACL rupture with a scheduled reconstruction surgery at this institution.\n4. The affected knee shows no significant redness, swelling, pain, or inflammation, with basic activities of daily living restored.\n5. No injury or only mild (grade I) injury to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament.\n\nExclusion Criteria:\n\n1. Body mass index (BMI) less than 18.5 or greater than 35 kg/m².\n2. Age older than 45 years or younger than 18 years.\n3. ACL rupture with a duration exceeding 3 months.\n4. 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).\n5. Concurrent severe meniscal tear.\n6. History of prior knee surgery (e.g., meniscal repair, ligament reconstruction, joint replacement, arthroscopic debridement).\n7. Presence of other significant knee pathologies, such as: knee osteoarthritis, knee tumor, rheumatoid arthritis, tuberculosis, or active infectious/inflammatory diseases of the knee.\n8. Concurrent fracture, dislocation, or other osseous injuries involving the knee.\n9. Unwillingness to receive the treatment protocol of this study.'}, 'identificationModule': {'nctId': 'NCT07423767', 'briefTitle': 'Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'M20251095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Intervention Group', 'description': 'Following the initial outpatient visit, participants in the experimental group will receive:\n\n1. A Single Face-to-Face Psychological Guidance Session (Encouraging Attempts at Pain-Free Activity), which includes:\n\n 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.\n2. Weekly Telephone Follow-ups (for a duration of 3-4 weeks), with each call designed to:\n\nProvide ongoing psychological support. Inquire about the status of the knee joint. Encourage the continued practice of normal activities without crutches or brace.', 'interventionNames': ['Other: Cognitive-Behavioral Intervention']}, {'type': 'OTHER', 'label': 'No Intervention: Control Group', 'description': "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.", 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Cognitive-Behavioral Intervention', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Cognitive Behavioral Intervention Group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'This group receives standard preoperative care only (no psychological intervention). They undergo identical outcome assessments at the same time points as the intervention group.', 'armGroupLabels': ['No Intervention: Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Shuang Ren', 'role': 'CONTACT', 'email': 'xixishuang123@126.com', 'phone': '17610252992'}], 'facility': 'Peking university third hospital, Beijing,', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shuang Ren, PhD', 'role': 'CONTACT', 'email': 'xixishuang123@126.com', 'phone': '17610252992'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}