Clinical trial NCT06347523: VR-Based Preoperative Rehabilitation Program for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
Official title: The Application of a Preoperative Rehabilitation Program Based on Virtual Reality (VR) Technology in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament (ACL) Reconstruction
Preoperative Rehabilitation
Lead sponsor: First Affiliated Hospital of Shantou University Medical College
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: knee joint range of motion
timeFrame: through study completion, an average of 6 months
measure: Lysholm knee function score
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: SAS self-rating anxiety scale scale
timeFrame: through study completion, an average of 6 months
measure: SDS self-rating depression scale scale
timeFrame: through study completion, an average of 6 months
measure: Visual Analog Scale pain score
timeFrame: through study completion, an average of 6 months
measure: Barthel Index for basic activities of daily living
timeFrame: through study completion, an average of 6 months
measure: time to first ambulation post-surgery
timeFrame: through study completion, an average of 6 months
Other outcomes:
measure: postoperative complications
timeFrame: through study completion, an average of 6 months
measure: nursing satisfaction
timeFrame: through study completion, an average of 6 months
Locations:
city: Shantou
country: China
facility: "The First Affiliated Hospital of Shantou University Medical College
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital of Shantou University Medical College
name: Yongsong Chen
role: STUDY_DIRECTOR
References: