The Effects of Non-Immersive Virtual Reality Exercises on Muscle Excitability in Knee Osteoarthritis

NCT ID: NCT05595317

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-29
• Study Completion Date: 2023-09-03

Brief Summary

The main goal of this sham-controlled clinical trial is to learn the excitability levels of the muscles around the knee and balance using objective measurement methods in patients with knee osteoarthritis of non-immersive virtual reality application. The secondary aims of the study are to investigate in which direction the proprioception, physical function level, independence level in activities of daily living, muscle endurance around the knee and patient satisfaction change with non-immersive virtual reality application in patients with knee osteoarthritis. In this study, main questions are to answer:

1. Are non-immersive virtual reality-based knee exercises effective on muscle excitability around the knee and balance in patients with knee osteoarthritis?

2. Are non-immersive virtual reality-based knee exercises effective in improving the level of physical function in patients with knee osteoarthritis?

The data collection part of this study will be carried out on volunteers, male and female, who have been diagnosed with knee osteoarthritis by a Physical Medicine and Rehabilitation specialist at Erzurum Atatürk University Training and Research Hospital. After informing the participants about the study, the consent form will be signed. Participants will be patients receiving routine outpatient physical therapy. The study was planned as a randomized controlled trial with a sham-control group.

The study group will receive non-immersive virtual reality in addition to traditional physiotherapy, and the control group will receive sham virtual reality exercise in addition to traditional physiotherapy.

Detailed Description

Estimated Forty-four volunteer participants with knee osteoarthritis over 18 years who will be at stage of 1-3 according to the Kellgren Lawrence radiological evaluation will be included in the study. The groups will be formed by computerized randomization method after stratification based on gender and knee osteoarthritis severity.

The study group will receive 45 minutes of traditional physiotherapy a day, 5 days a week for 3 weeks, plus 30 minutes of non-immersive virtual reality-based knee joint exercises. The sham-control group will receive 45 minutes of traditional physiotherapy a day, 5 days a week for 3 weeks and 30 minutes of sham non-immersive virtual reality practice.

Demographic data will be evaluated by Demographic Information Form, muscle excitability will be evaluated by superficial Electromyography (EMG) and static balance will be evaluated by Tetrax posturography device. Knee joint proprioception sensation will be achieved with the Protractor and Angle Gauge (Toolkit, Korea) application. Physical function assessment with Western Ontario and McMaster Universities Arthritis Index (WOMAC), independence level with Katz Activities of Daily Living Independence Index, muscular endurance with 30-second stand-up test (30 Seconds Chair Stand Test), dynamic balance with Timed Up and Go test, Participants' satisfaction with the treatment they receive will be evaluated with a 10-centimeter Visual Analogue Scale (VAS). Measurements will be performed at baseline and at the end of the 3rd week of treatment as post-intervention.

Conditions

Knee Osteoarthritis; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Study group

Traditional physiotherapy + A non-immersive virtual reality game will be played to provide treatment for lower limbs.

Group Type: EXPERIMENTAL

Non-immersive Virtual Reality

Intervention Type: DEVICE

The traditional physiotherapy program will consist of hot pack (15 minutes), TENS (20 minutes), and 1 set of /10 repetitions of knee flexion/extension exercise for the right and left in a sitting position with hands clasped on opposite shoulders. In the non-immersive virtual reality application, Microsoft Kinect Xbox 360 Adventures games will be applied at the light level exercise level under the supervision of a physiotherapist. The participant will play a game in which he stands in a standing boat in a boat going on a flowing river and has to overcome obstacles by jumping, crouching and stepping left and right (River rush game).

Sham-controlled group

Traditional physiotherapy + A sham non-immersive virtual reality game will be played but not provides treatment for lower limbs.

Group Type: SHAM_COMPARATOR

Sham Non-immersive Virtual Reality

Intervention Type: DEVICE

The traditional physiotherapy program will consist of hot pack (15 minutes), TENS (20 minutes), and 1 set of /10 repetitions of knee flexion/extension exercise for the right and left in a sitting position with hands clasped on opposite shoulders. As a sham application, the participants will sit in a chair in front of the screen and try to prevent the balls sent from the opposite direction by using their upper extremities while their bodies are fixed with the help of a belt, under the supervision of a physiotherapist (Rally ball game).

Interventions

Non-immersive Virtual Reality

The traditional physiotherapy program will consist of hot pack (15 minutes), TENS (20 minutes), and 1 set of /10 repetitions of knee flexion/extension exercise for the right and left in a sitting position with hands clasped on opposite shoulders. In the non-immersive virtual reality application, Microsoft Kinect Xbox 360 Adventures games will be applied at the light level exercise level under the supervision of a physiotherapist. The participant will play a game in which he stands in a standing boat in a boat going on a flowing river and has to overcome obstacles by jumping, crouching and stepping left and right (River rush game).

Intervention Type: DEVICE

Sham Non-immersive Virtual Reality

The traditional physiotherapy program will consist of hot pack (15 minutes), TENS (20 minutes), and 1 set of /10 repetitions of knee flexion/extension exercise for the right and left in a sitting position with hands clasped on opposite shoulders. As a sham application, the participants will sit in a chair in front of the screen and try to prevent the balls sent from the opposite direction by using their upper extremities while their bodies are fixed with the help of a belt, under the supervision of a physiotherapist (Rally ball game).

Intervention Type: DEVICE

Other Intervention Names

Microsoft Kinect Xbox 360 based therapy; Kinect sensors based therapy; Commercial game consoles based therapy; Microsoft Kinect Xbox 360 based sham therapy; Kinect sensors based sham therapy; Commercial game consoles based sham therapy

Eligibility Criteria

Inclusion Criteria

• Those over the age of 18
• Those with a Kellgren and Lawrence score between 1-3
• Those who can walk > 15 m independently
• Those who agreed to participate in the study.

Exclusion Criteria

• Those with knee osteoarthritis with any contagious infection, autoimmune disease or fracture
• Those with a history of malignancy, dizziness, vertigo or stroke that may affect posture and balance, or a history of underlying neurological and vestibular disease
• Those who have undergone any knee operation
• Those receiving injection therapy for knee OA

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mehmet Sönmez

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Sönmez

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Şebnem AVCI, PhD

Role: STUDY_DIRECTOR

Abant Izzet Baysal University

Locations

Erzurum Technical University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ErzurumTU

Identifier Type: -

Identifier Source: org_study_id