VR-Based Preoperative Rehabilitation Program for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction

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.

Study Overview

• Status: Terminated
• Conditions: Anterior Cruciate Ligament (ACL) Reconstruction; Preoperative Rehabilitation
• Intervention / Treatment: Procedure: The VR-based preoperative rehabilitation program;; Procedure: standard nursing care,

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shantou, Guangdong, China, 515000
      • "The First Affiliated Hospital of Shantou University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Individuals with cognitive impairments, severe hearing or vision impairments, limb paralysis, or non-compliance with the experiment will be excluded from participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; The experimental group will receive an enhanced preoperative rehabilitation program incorporating Virtual Reality (VR) technology	Procedure: The VR-based preoperative rehabilitation 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.; Other Names: Virtual Reality Rehabilitation Program, VR Pre-op Rehab, VR Rehab Program
Active Comparator: control group; The control group will receive standard nursing care.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee joint range of motion	This refers to the bending of the knee joint, bringing the heel toward the buttocks	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.	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	Postoperative complications include any unexpected medical conditions or events that arise in a patient after surgery. These complications can include infections, bleeding, organ dysfunction, adverse reactions to anesthesia or medications, wound problems, and other health-related issues.	through study completion, an average of 6 months
nursing satisfaction	Nursing satisfaction involves evaluating how content and fulfilled nursing staff or healthcare providers are with their professional roles, workplace conditions, and the support they receive. It measures their overall sense of well-being and job satisfaction.	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Shantou University Medical College
• Investigators: Study Director: Yongsong Chen, First Affiliated Hospital of Shantou University Medical College

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FirstShantou

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: The data will become available within a specified period after the publication of primary results, within 6 to 12 months

IPD Sharing Access Criteria

Research Purpose: only those planning further analysis or validation studies related to the original trial would qualify for data access.

Data Request Procedure: Access seekers must submit their requests through a designated data request procedure. This procedure may require them to provide detailed information such as research plans, data utilization strategies, and anticipated outcomes.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No