Anterior Cruciate Ligament (ACL) TearNCT07423767
Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction
A study testing Cognitive-Behavioral Intervention in people with Anterior Cruciate Ligament (ACL) Tear, run by Peking University Third Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tear
- What is being tested?
- Cognitive-Behavioral Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesChina
- Study dates
- 14 Feb 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking university third hospital, Beijing,
Beijing, None Selected, 100191
Shuang Ren, 15291492217, xixishuang123@126.com
- Not yet recruiting
Peking university third hospital, Beijing,
Beijing
Shuang Ren, 17610252992, xixishuang123@126.com
About this study
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.
Read the detailed description
- 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.
- Conditions
- Anterior Cruciate Ligament (ACL) Tear
- Being tested
- Cognitive-Behavioral Intervention, Control group
- Keywords
- Anterior cruciate ligament; Cognitive-Behavioral Intervention
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral InterventionOther
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 groupOther
This group receives standard preoperative care only (no psychological intervention). They undergo identical outcome assessments at the same time points as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start14 Feb 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL) TearStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423767
- Sponsor's protocol ID
- M20251095
- Status last verified
- Oct 2025
- First submitted
- 13 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Preoperative Cognitive-Behavioral Intervention on Kinesiophobia and Function in Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07423767
- Acronym / sponsor ID
- M20251095
- Conditions
- Anterior Cruciate Ligament (ACL) Tear
- Keywords
- Anterior cruciate ligament; Cognitive-Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 14 Feb 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Intervention Group | Experimental | Other: Cognitive-Behavioral InterventionFollowing 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. |
| No Intervention: Control Group | Other | Other: Control groupParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral InterventionThis 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. | Other | Cognitive Behavioral Intervention Group |
| Control groupThis group receives standard preoperative care only (no psychological intervention). They undergo identical outcome assessments at the same time points as the intervention group. | Other | No Intervention: Control Group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Intervention in people with Anterior Cruciate Ligament (ACL) Tear, run by Peking University Third Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuang Ren, PhD (17610252992, xixishuang123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.