Anterior Cruciate Ligament (ACL) ReconstructionNCT06347523
VR-Based Preoperative Rehabilitation Program for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
A study testing The VR-based preoperative rehabilitation program; and standard nursing care, in people with Anterior Cruciate Ligament (ACL) Reconstruction and Preoperative Rehabilitation, run by First Affiliated Hospital of Shantou University Medical College at 1 site in China.
Trial summary
Between April 2, 2024, and October 1, 2024, a study will be conducted at the Department of Orthopedics in the First Affiliated Hospital of Shantou University Medical College involving 120 patients who will undergo anterior cruciate ligament reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Reconstruction, Preoperative Rehabilitation
- What is being tested?
- The VR-based preoperative rehabilitation program; and standard nursing care,
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals eligible for inclusion in the study are those who undergo their initial anterior cruciate ligament (ACL) reconstruction surgery, aged between 18 and 60 years, possess adequate hearing and vision, have clear consciousness, and demonstrate proficient language communication skills.
Who cannot join
- Individuals with cognitive impairments, severe hearing or vision impairments, limb paralysis, or non-compliance with the experiment will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
China1 site
"The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515000
About this study
Official title: The Application of a Preoperative Rehabilitation Program Based on Virtual Reality (VR) Technology in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
Between April 2, 2024, and October 1, 2024, a study will be conducted at the Department of Orthopedics in the First Affiliated Hospital of Shantou University Medical College involving 120 patients who will undergo anterior cruciate ligament reconstruction surgery. They will be randomly divided into two groups: an experimental group and a control group.
Read the detailed description
The control group will receive standard nursing care, while the experimental group will receive an enhanced preoperative rehabilitation program incorporating Virtual Reality (VR) technology. This program will include patient assessments, personalized exercise prescriptions, and VR-based educational videos covering psychological support, nutritional guidance, and exercise instructions.
Patients in the experimental group will use VR headsets for preoperative and postoperative interactive training sessions, as well as for viewing postoperative educational videos. The intervention will start upon admission and will continue until discharge.
Primary outcome measures will include knee joint range of motion and the Lysholm knee function score. Secondary measures will encompass anxiety, depression, pain scores, activities of daily living, time to ambulation, postoperative complications, and patient satisfaction.
Statistical analysis will be conducted to compare outcomes between the two groups.
- Being tested
- The VR-based preoperative rehabilitation program;, standard nursing care,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The VR-based preoperative rehabilitation program;Procedure or surgery
Also called Virtual Reality Rehabilitation Program, VR Pre-op Rehab, VR Rehab Program
Patients are provided with VR headsets for personalized pre-rehabilitation educational videos prior to surgery. These videos cover psychological counseling, nutritional advice, and exercise instructions. Additionally, patients engage in VR interactive functional training. After surgery, patients continue with VR technology interactive functional training and watch postoperative educational videos. This intervention is initiated upon the patient's admission and continues until their discharge.
standard nursing care,Procedure or surgery
Patients in the control group receive traditional preoperative rehabilitation methods, which may include the following interventions: Joint exercises and rehabilitation exercises guided by a physical therapist. Written or verbal rehabilitation educational materials.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group will receive an enhanced preoperative rehabilitation program incorporating Virtual Reality (VR) technology Receives: Procedure: The VR-based preoperative rehabilitation program; |
| control group | Active comparator | The control group will receive standard nursing care. Receives: Procedure: standard nursing care, |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee joint range of motion
This refers to the bending of the knee joint, bringing the heel toward the buttocks
Measured: through study completion, an average of 6 months
Lysholm knee function score
The Lysholm knee function score typically includes a series of questions or items that ask the patient to rate their ability to perform various activities and movements involving the knee joint. These activities may include walking, running, squatting, climbing stairs, and other functional tasks. Patients are asked to rate their knee function and any associated symptoms such as pain or instability.
The scoring system for the Lysholm knee function score can vary, but it often ranges from 0 to 100, with higher scores indicating better knee function and lower scores suggesting greater impairment or limitations.
Measured: through study completion, an average of 6 months
Secondary outcomes (5)
SAS self-rating anxiety scale scale
The SAS scale typically consists of 20 items that assess both psychological and physical symptoms of anxiety, such as nervousness, restlessness, tension, and palpitations. Individuals are asked to rate how often they have experienced each symptom over a specific period, often the past week or two weeks. Responses are typically scored on a Likert scale, where higher scores indicate a greater degree of anxiety symptom severity.
The total score on the SAS scale provides an overall measure of an individual's anxiety level. Higher scores indicate a higher level of anxiety, while lower scores suggest a lower level of anxiety.
Measured: through study completion, an average of 6 months
SDS self-rating depression scale scale
The SDS scale typically consists of 20 items that assess various aspects of depression, including mood, sleep patterns, appetite changes, and physical symptoms. Individuals are asked to rate how often they have experienced each symptom over a specific period, often the past week or two weeks. Responses are typically scored on a Likert scale, where higher scores indicate a greater degree of depression symptom severity.
The total score on the SDS scale provides an overall measure of an individual's depression level. Higher scores suggest a higher level of depressive symptoms, while lower scores indicate a lower level of depressive symptoms.
Measured: through study completion, an average of 6 months
Visual Analog Scale pain score
The VAS pain score consists of a horizontal or vertical line, typically 10 centimeters in length. One end of the line is labeled "No Pain," indicating the absence of pain, while the other end is labeled "Worst Pain Imaginable," signifying the most severe pain imaginable.
Assessment: Patients or study participants are asked to mark a point on the line that represents their current level of pain. The distance from the "No Pain" end to the marked point is measured in millimeters, and this measurement is recorded as the pain score.
Scoring: The VAS pain score is recorded as a number on a scale from 0 to 10, where 0 indicates no pain, and 10 represents the worst possible pain. Higher scores correspond to higher perceived pain intensity.
Measured: through study completion, an average of 6 months
Barthel Index for basic activities of daily living
The Barthel Index (BI) is a widely used tool for assessing an individual's level of independence in performing basic daily life activities. It comprises a series of tasks, such as eating, bathing, dressing, toileting, transferring from bed to chair, walking, and climbing stairs, among others. Each task is scored based on the individual's level of independence in completing it.
Total Score: The total score on the Barthel Index is calculated by summing the scores for each task. Typically, the maximum score is 100, indicating complete independence in all assessed activities.
Measured: through study completion, an average of 6 months
time to first ambulation post-surgery
it aims to assess when patients start moving after surgery, whether it's independent walking or with some degree of assistance.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start2 Apr 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Why it stopped: The sample size is insufficient
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) ReconstructionStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Shantou University Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeshan Chen, First Affiliated Hospital of Shantou University Medical College
- Investigators
- Yongsong Chen, Study director, First Affiliated Hospital of Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347523
- Sponsor's protocol ID
- FirstShantou
- Status last verified
- Aug 2025
- First submitted
- 22 Mar 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scope of Data: The shared IPD will include participants' demographic information, ACL injury characteristics, treatment plans, recovery progress, and complication records. Data Format: The shared de-identified individual participant data will be provided in Excel format. Access Procedures: Access to the data will be granted through the submission of a data request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of a Preoperative Rehabilitation Program Based on Virtual Reality (VR) Technology in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
- ClinicalTrials.gov ID
- NCT06347523
- Acronym / sponsor ID
- FirstShantou
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sample size is insufficient
- Enrolment
- 100 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Shantou University Medical CollegeUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 4 Apr 2024 (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.
Between April 2, 2024, and October 1, 2024, a study will be conducted at the Department of Orthopedics in the First Affiliated Hospital of Shantou University Medical College involving 120 patients who will undergo anterior cruciate ligament reconstruction surgery. They will be randomly divided into two groups: an experimental group and a control group.
Detailed description
The control group will receive standard nursing care, while the experimental group will receive an enhanced preoperative rehabilitation program incorporating Virtual Reality (VR) technology. This program will include patient assessments, personalized exercise prescriptions, and VR-based educational videos covering psychological support, nutritional guidance, and exercise instructions.
Patients in the experimental group will use VR headsets for preoperative and postoperative interactive training sessions, as well as for viewing postoperative educational videos. The intervention will start upon admission and will continue until discharge.
Primary outcome measures will include knee joint range of motion and the Lysholm knee function score. Secondary measures will encompass anxiety, depression, pain scores, activities of daily living, time to ambulation, postoperative complications, and patient satisfaction.
Statistical analysis will be conducted to compare outcomes between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: The VR-based preoperative rehabilitation program;The experimental group will receive an enhanced preoperative rehabilitation program incorporating Virtual Reality (VR) technology |
| control group | Active comparator | Procedure: standard nursing care,The control group will receive standard nursing care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals eligible for inclusion in the study are those who undergo their initial anterior cruciate ligament (ACL) reconstruction surgery, aged between 18 and 60 years, possess adequate hearing and vision, have clear consciousness, and demonstrate proficient language communication skills.
Key exclusion criteria (1 listed)
- Individuals with cognitive impairments, severe hearing or vision impairments, limb paralysis, or non-compliance with the experiment will be excluded from participation.
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 |
|---|---|---|
| The VR-based preoperative rehabilitation program;Also: Virtual Reality Rehabilitation Program, VR Pre-op Rehab, VR Rehab ProgramPatients are provided with VR headsets for personalized pre-rehabilitation educational videos prior to surgery. These videos cover psychological counseling, nutritional advice, and exercise instructions. Additionally, patients engage in VR interactive functional training. After surgery, patients continue with VR technology interactive functional training and watch postoperative educational videos. This intervention is initiated upon the patient's admission and continues until their discharge. | Procedure or surgery | experimental group |
| standard nursing care,Patients in the control group receive traditional preoperative rehabilitation methods, which may include the following interventions: Joint exercises and rehabilitation exercises guided by a physical therapist. Written or verbal rehabilitation educational materials. | Procedure or surgery | control group |
Primary outcome
knee joint range of motion
Time frame: through study completion, an average of 6 months
This refers to the bending of the knee joint, bringing the heel toward the buttocks
Lysholm knee function score
Time frame: through study completion, an average of 6 months
The Lysholm knee function score typically includes a series of questions or items that ask the patient to rate their ability to perform various activities and movements involving the knee joint. These activities may include walking, running, squatting, climbing stairs, and other functional tasks. Patients are asked to rate their knee function and any associated symptoms such as pain or instability. The scoring system for the Lysholm knee function score can vary, but it often ranges from 0 to 100, with higher scores indicating better knee function and lower scores suggesting greater impairment or limitations.
5 secondary outcomes
SAS self-rating anxiety scale scale
Time frame: through study completion, an average of 6 months
SDS self-rating depression scale scale
Time frame: through study completion, an average of 6 months
Visual Analog Scale pain score
Time frame: through study completion, an average of 6 months
Barthel Index for basic activities of daily living
Time frame: through study completion, an average of 6 months
time to first ambulation post-surgery
Time frame: through study completion, an average of 6 months
Results and safety
The study was stopped early (reason given: The sample size is insufficient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Yes. Scope of Data: The shared IPD will include participants' demographic information, ACL injury characteristics, treatment plans, recovery progress, and complication records. Data Format: The shared de-identified individual participant data will be provided in Excel format. Access Procedures: Access to the data will be granted through the submission of a data request.
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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. This study is not recruiting at the moment.
Yongsong Chen study director
First Affiliated Hospital of Shantou University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The VR-based preoperative rehabilitation program; and standard nursing care, in people with Anterior Cruciate Ligament (ACL) Reconstruction and Preoperative Rehabilitation, run by First Affiliated Hospital of Shantou University Medical College at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: The sample size is insufficient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee joint range of motion (time frame: through study completion, an average of 6 months). 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 7 Aug 2025.