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

NCT06347523 | Terminated

• 1 other identifier: FirstShantou
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. They will be randomly divided into two groups: an experimental group and a control group.

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction; Preoperative Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• SAS self-rating anxiety scale scale

  through study completion, an average of 6 months

• SDS self-rating depression scale scale

  through study completion, an average of 6 months

• Visual Analog Scale pain score

  through study completion, an average of 6 months

• Barthel Index for basic activities of daily living

  through study completion, an average of 6 months

• time to first ambulation post-surgery

  through study completion, an average of 6 months

Other Outcomes (2)

• postoperative complications

  through study completion, an average of 6 months

• nursing satisfaction

  through study completion, an average of 6 months

Study Arms (2)

experimental group

EXPERIMENTAL

The experimental group will receive an enhanced preoperative rehabilitation program incorporating Virtual Reality (VR) technology

Procedure: The VR-based preoperative rehabilitation program;

control group

ACTIVE COMPARATOR

The control group will receive standard nursing care.

Procedure: standard nursing care,

Interventions

The VR-based preoperative rehabilitation program; PROCEDURE

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.

Also known as: Virtual Reality Rehabilitation Program, VR Pre-op Rehab, VR Rehab Program

experimental group

standard nursing care, PROCEDURE

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.

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Shantou University Medical College: lead

Study Sites (1)

"The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515000, China

Location

Study Officials

• Yongsong Chen

  First Affiliated Hospital of Shantou University Medical College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Researcher

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 4, 2024
• Study Start: April 2, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available within a specified period after the publication of primary results, within 6 to 12 months
• 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.

Locations

CN (1)