Effects of Virtual Reality in TKA Patients

NCT05875324 | Completed

• 1 other identifier: 611
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Knee arthroplasty; VR; Exercise; Pain; Kinesiophobia; Catastrophization; Function

Outcome Measures

Primary Outcomes (2)

• Kinesiophobia assessed by Tampa Kinesiophobia Scale

  Kinesiophobia was evaluated by using the Tampa Kinesiophobia Scale (total score between 17-68) (higher values indicate higher kinesiophobia). The Tampa Kinesiophobia Scale includes the parameters of injury/re-injury and fear of movement; scores of 37 and above indicate the presence of high kinesiophobia (ICC: 0,806).

  first day after TKA

• Kinesiophobia assessed by Tampa Kinesiophobia Scale

  Kinesiophobia was evaluated by using the Tampa Kinesiophobia Scale (total score between 17-68) (higher values indicate higher kinesiophobia). The Tampa Kinesiophobia Scale includes the parameters of injury/re-injury and fear of movement; scores of 37 and above indicate the presence of high kinesiophobia (ICC: 0,806).

  4th week after TKA

Secondary Outcomes (12)

• knee pain assessed by Numerical Pain Rating Scale

  first day after TKA

• knee pain assessed by Numerical Pain Rating Scale

  4th week after TKA

• pain catastrophizing assessed by Pain Catastrophizing Scale

  first day after TKA

• pain catastrophizing assessed by Pain Catastrophizing Scale

  4th week after TKA

• knee range of motion assessed by universal goniometer

  first day after TKA

Study Arms (2)

VR Group

EXPERIMENTAL

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.

Device: virtual reality application; Other: exercise

Exercise Group

ACTIVE COMPARATOR

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.

Other: exercise

Interventions

virtual reality application 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.

VR Group

exercise 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; VR Group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: It has been determined that women's proportion of knee extensors, knee flexors and knee Flexors / extensors ratio when compared with men, the ratio of the knee extender and flexor muscle groups is different in relation to the overall body muscle mass, and there are differences in functional outcomes in women and men in the early post-TKA period. It is also believed that women have more pain sensitivity than men and that pain inhibition mechanisms are less effective. Only female patients were included in this study because differences between groups and within-groups could not affect the results of the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırklareli University: lead
• Gazi University: collaborator

Study Sites (1)

Kırklareli University

Kırklareli, 39000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Pain; Kinesiophobia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: May 25, 2023
• Study Start: October 13, 2019
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

TU (1)