Knee OsteoarthritisNCT05595317
The Effects of Non-Immersive Virtual Reality Exercises on Muscle Excitability in Knee Osteoarthritis
A study testing Non-immersive Virtual Reality in people with Knee Osteoarthritis and Virtual Reality, run by Mehmet Sönmez at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Virtual Reality
- What is being tested?
- Non-immersive Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Oct 2022to 3 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of the Effects of Non-Immersive Virtual Reality Exercises on Muscle Excitability Around the Knee and Balance in Patients With Knee Osteoarthritis
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:
- Are non-immersive virtual reality-based knee exercises effective on muscle excitability around the knee and balance in patients with knee osteoarthritis?
- Are non-immersive virtual reality-based knee exercises effective in improving the level of physical function in patients with knee osteoarthritis?
Read more
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.
Read the 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
- Being tested
- Non-immersive Virtual Reality, Sham Non-immersive Virtual Reality
- Keywords
- Balance, Muscle excitability
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-immersive Virtual RealityDevice
Also called Microsoft Kinect Xbox 360 based therapy, Kinect sensors based therapy, Commercial game consoles based therapy
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 Non-immersive Virtual RealityDevice
Also called Microsoft Kinect Xbox 360 based sham therapy, Kinect sensors based sham therapy, Commercial game consoles based sham therapy
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).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Traditional physiotherapy + A non-immersive virtual reality game will be played to provide treatment for lower limbs. Receives: 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. Receives: Device: Sham Non-immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline static balance at week 3.
Secondary outcomes (6)
Knee Proprioception
Protractor and Angle Gauge (Toolkit, Korea) will be used to evaluate knee proprioception.It is a free phone application that evaluates by measuring the angular changes precisely by marking the joints through an application.
Measured: Change from baseline knee proprioception at week 3.
Physical Function Level
Physical function level will be assessed with Western Ontario and McMaster Universities Arthritis Index (WOMAC) Turkish version. It is a scale that evaluates the disability associated with these conditions in hip and/or knee osteoarthritis. It consists of three parts: pain, stiffness and physical function. It contains a total of 24 items. Items are scored on a Likert scale. The degree of pain and strain is indicated by giving points from 0 to 4 on the Likert scale. Total score can be between 0-96 points. Higher score indicates worse functional level.
Measured: Change from baseline Physical Function Level at week 3.
Independence in Activities of Daily Living
KATZ Index Turkish version will be used to evaluate Independence in Activities of Daily Living. It determines the independence levels of the participants in 6 different areas: bathing, dressing, toileting, transfer, continence and feeding. It is scored from 0 to 6 points. 0 means dependent, 6 means fully independent.
Measured: Change from baseline Independence in Activities of Daily Living at week 3.
Muscle Endurance
The muscle endurance will be measured with 30 Seconds Chair Stand Test. It is a test that evaluates the participant's sitting and standing endurance. The number of sit-ups performed during 30 seconds is recorded. If it is less than 10, the endurance is considered insufficient.
Measured: Change from baseline Endurance at week 3.
Dynamic Balance
Dynamic balance measurement will be performed by using Timed Up and Go test.This test requires a standard chair, a stopwatch, and a 3-metre hole. The participant gets up from the chair at the command and returns from the marked point 3 meters ahead, sits on the chair and the time is recorded. If it is longer than 12 seconds, it is said that there is a dynamic balance disorder.
Measured: Change from baseline Dynamic Balance at week 3.
Patient Satisfaction from Treatment
Visual Analogue Scale will be used to evaluate patient satisfaction regarding treatment. This scale is found by measuring the distance of the marked point with the help of a ruler after the participant randomly marks any point on a 10 cm long horizontal line. On the line, the leftmost point is marked as dissatisfied, and the rightmost point is marked as very satisfied with the treatment. Participants mark any point above or between these two points. Higher score show more satisfaction level.
Measured: At week 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start29 Oct 2022
- Primary completion30 Apr 2023
- Study completion3 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Study group will take Non-immersive Virtual reality (VR) exercise, sham controlled group will take sham VR.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Sönmez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Sönmez, Erzurum Technical University
- Investigators
- Şebnem AVCI, PhD, Study director, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595317
- Sponsor's protocol ID
- ErzurumTU
- Status last verified
- Sep 2023
- First submitted
- 17 Oct 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Effects of Non-Immersive Virtual Reality Exercises on Muscle Excitability Around the Knee and Balance in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05595317
- Acronym / sponsor ID
- ErzurumTU
- Conditions
- Knee Osteoarthritis, Virtual Reality
- Keywords
- Balance, Muscle excitability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mehmet SönmezUniversity, hospital or other
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 3 Sep 2023 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are non-immersive virtual reality-based knee exercises effective on muscle excitability around the knee and balance in patients with knee osteoarthritis?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Study group will take Non-immersive Virtual reality (VR) exercise, sham controlled group will take sham VR.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Non-immersive Virtual RealityTraditional physiotherapy + A non-immersive virtual reality game will be played to provide treatment for lower limbs. |
| Sham-controlled group | Sham comparator | Device: Sham Non-immersive Virtual RealityTraditional physiotherapy + A sham non-immersive virtual reality game will be played but not provides treatment for lower limbs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-immersive Virtual RealityAlso: Microsoft Kinect Xbox 360 based therapy, Kinect sensors based therapy, Commercial game consoles based therapyThe 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). | Device | Study group |
| Sham Non-immersive Virtual RealityAlso: Microsoft Kinect Xbox 360 based sham therapy, Kinect sensors based sham therapy, Commercial game consoles based sham therapyThe 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). | Device | Sham-controlled group |
Primary outcome
Muscle Excitability
Time frame: Change from baseline muscle excitability at week 3.
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.
Static Balance
Time frame: Change from baseline static balance at week 3.
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.
6 secondary outcomes
Knee Proprioception
Time frame: Change from baseline knee proprioception at week 3.
Physical Function Level
Time frame: Change from baseline Physical Function Level at week 3.
Independence in Activities of Daily Living
Time frame: Change from baseline Independence in Activities of Daily Living at week 3.
Muscle Endurance
Time frame: Change from baseline Endurance at week 3.
Dynamic Balance
Time frame: Change from baseline Dynamic Balance at week 3.
Patient Satisfaction from Treatment
Time frame: At week 3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şebnem AVCI, PhD study director
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-immersive Virtual Reality in people with Knee Osteoarthritis and Virtual Reality, run by Mehmet Sönmez at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Excitability (time frame: Change from baseline muscle excitability at week 3.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.