Effects of Virtual Reality in TKA Patients

NCT ID: NCT05875324

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-13
• Study Completion Date: 2021-08-10

Brief Summary

The goal of this clinical trial] is to investigate the effects of virtual reality (VR) in patients undergoing total knee arthroplasty (TKA). The main questions it aims to answer are:

• Does VR have effects on pain, kinesiophobia, and function during the early rehabilitation period of patients who have undergone TKA
• Does VR contribute to the success of exercise treatment after TKA

All the patients included in the study were informed about the disease, the goals of post-surgical rehabilitation, the conditions to be considered after TKA and exercises. Sitting on the side of the bed and mobilization in or out of the room with a walker were provided with the postoperative 1st day exercises. The patients were discharged 2.5 days after surgery. The patients in both groups were taught an exercise program for home practice.

In addition to the exercise program, the virtual reality application was applied before the exercises to the VR group. The second evaluation was made 3 days after the end of the treatment in both patient groups.

Researchers compared VR and exercise to see if pain, kinesiophobia, pain catastrophizing, knee range of motion, function, and quality of life had changed.

Conditions

Knee Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR Group

The patients in the VR group were informed about the disease, the goals of post-surgical rehabilitation, the exercises, and the circumstances to be considered following TKA. On the postoperative first day, activities included sitting on the side of the bed and mobilizing in and out of the room using a walker. Patients were discharged 2.5 days after surgery. Patients were provided an exercise program for at-home practice. In addition to the exercise program, VR glasses were used before the exercises in the VR group. The second examination was performed three days after the completion of treatment.

Group Type: EXPERIMENTAL

virtual reality application

Intervention Type: DEVICE

VR was used for 10 minutes a day in the sitting position for three weeks, twice a week, by watching a walking video before beginning the exercises. Patients were instructed to imagine themselves walking while concentrating on walking and watching the video. The patients were asked to stop watching video by removing their VR glass if they experienced discomfort such as dizziness and nausea during the VR application. They were told to continue watching the video when the discomfort was gone. In cases where similar discomforts recurred, the treatment was terminated.

exercise

Intervention Type: OTHER

activities included sitting on the side of the bed and mobilizing in and out of the room using a walker. Patients were provided an exercise program for at-home practice.

Exercise Group

Exercise group were informed about the disease, the goals of post-surgical rehabilitation, the exercises, and the circumstances to be considered following TKA. On the postoperative first day, activities included sitting on the side of the bed and mobilizing in and out of the room using a walker. Patients were discharged 2.5 days after surgery. Patients in the exercise group were provided an exercise program for at-home practice. The second examination was performed three days after the completion of treatment.

Group Type: ACTIVE_COMPARATOR

exercise

Intervention Type: OTHER

activities included sitting on the side of the bed and mobilizing in and out of the room using a walker. Patients were provided an exercise program for at-home practice.

Interventions

virtual reality application

VR was used for 10 minutes a day in the sitting position for three weeks, twice a week, by watching a walking video before beginning the exercises. Patients were instructed to imagine themselves walking while concentrating on walking and watching the video. The patients were asked to stop watching video by removing their VR glass if they experienced discomfort such as dizziness and nausea during the VR application. They were told to continue watching the video when the discomfort was gone. In cases where similar discomforts recurred, the treatment was terminated.

Intervention Type: DEVICE

exercise

activities included sitting on the side of the bed and mobilizing in and out of the room using a walker. Patients were provided an exercise program for at-home practice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being between the ages of 50 and 70
• Being female
• Having received TKA due to being at stage III or IV according to the Kellgren-Lawrence Osteoarthritis Classification
• Having sufficient eyesight
• Having kinesiophobia and pain catastrophizing

Exclusion Criteria

• Having undergone bilateral knee arthroplasty/revision knee arthroplasty
• Vertigo or motion-sensitive nausea
• Being diagnosed with an additional neurological, rheumatological, or oncological disease
• Having a Mini Mental Test score of less than 24
• Being diagnosed with severe anxiety by a specialist physician
• Inability to complete the treatment program

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: collaborator

Kırklareli University

OTHER

Sponsor Role: lead

Responsible Party

Ozan Gür, PT

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kırklareli University

Kırklareli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

611

Identifier Type: -

Identifier Source: org_study_id