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

NCT05595317 | Completed

• 1 other identifier: ErzurumTU
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis; Virtual Reality

Keywords

Balance; Muscle excitability

Outcome Measures

Primary Outcomes (2)

• Muscle Excitability

  Electromyography will be used to evaluate muscle excitability. Superficial electrodes will be used for assessments, no needle electrodes will be used. EMG or ENMG (electroneuromyography); It is expressed by the abbreviation of the terms electro (electrical), neuro (nerve), myo (muscle) and graphy (writing). Electromyography is a test used to measure the natural electrical activity of muscles. It can be determined that the disease, which is evaluated by EMG, originates from the muscle or nervous system. During the EMG process, the signals coming from the muscles and nerves are transferred to the digital environment as data through a special device and electrodes. The data in the digital environment are interpreted by neurologists and it is evaluated whether there is any abnormality. EMG is divided into two applications: surface EMG, where the electrodes are attached to the skin, and needle EMG, where the needle electrode is inserted into the muscle.

  Change from baseline muscle excitability at week 3.

• Static Balance

  The Tetrax® Interactive Static Posturography System (Tetrax°) (Sunlight Medical Ltd, Israel) will be used to assess static balance. It is a computerized posturography measuring device that is frequently used in the measurement of static balance. A total of 8 different measurements are made, with eyes open and closed. Eight different postures are evaluated for the test, and each posture is measured for 32 seconds. Initial stance, head up, eyes open (NO), then head upright, eyes closed (NC) stance is evaluated to limit visual impact; thereby emphasizing the influence of the somatic sense or vestibular organ. Next, four different postures are tested in the following order: head to the right (HR), head turned 45° to the right; head left (HL), head turned 45° left; Measurements are completed with the head back (HB), tilting the head back 30° and facing the ceiling, and forward (HF), tilting the head forward 30° and facing the floor.

  Change from baseline static balance at week 3.

Secondary Outcomes (6)

• Knee Proprioception

  Change from baseline knee proprioception at week 3.

• Physical Function Level

  Change from baseline Physical Function Level at week 3.

• Independence in Activities of Daily Living

  Change from baseline Independence in Activities of Daily Living at week 3.

• Muscle Endurance

  Change from baseline Endurance at week 3.

• Dynamic Balance

  Change from baseline Dynamic Balance at week 3.

Study Arms (2)

Study group

EXPERIMENTAL

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

Device: Non-immersive Virtual Reality

Sham-controlled group

SHAM COMPARATOR

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

Device: Sham Non-immersive Virtual Reality

Interventions

Non-immersive Virtual Reality 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).

Also known as: Microsoft Kinect Xbox 360 based therapy, Kinect sensors based therapy, Commercial game consoles based therapy

Study group

Sham Non-immersive Virtual Reality 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).

Also known as: Microsoft Kinect Xbox 360 based sham therapy, Kinect sensors based sham therapy, Commercial game consoles based sham therapy

Sham-controlled group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mehmet Sönmez: lead

Study Sites (1)

Erzurum Technical University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Şebnem AVCI, PhD

  Abant Izzet Baysal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Study group will take Non-immersive Virtual reality (VR) exercise, sham controlled group will take sham VR.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 26, 2022
• Study Start: October 29, 2022
• Primary Completion: April 30, 2023
• Study Completion: September 3, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)