Knee OsteoarthritisNCT04011553
The Effectiveness of Virtual Reality Based Rehabilitation in Patients With Knee Osteoarthritis
A study testing Virtual Reality based Rehabilitation Program in people with Knee Osteoarthritis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to investigate the effects of virtual reality based rehabilitation program on patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Virtual Reality based Rehabilitation Program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2018to 29 May 2019
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- knee osteoarhritis aged 40 to 75 years who were at stage of 2-3 according to the Kellegren Lawrence radiological evaluation were included in the study.
Who cannot join
- Those who have received physical therapy in the last 6 months
- Having serious systemic and cardiovascular diseases that may prevent exercise
- Neurological and orthopedic problems affecting gait
- Those with sensory defects
- Malignancy diagnosed
- Those who have received PRP (Platelet-Rich Plasma) treatment or intra-articular steroid injection treatment in the last 6 months
Show all 9Show fewer
- With metal implants
- Serious hearing loss or visual impairment
- Communication problems
Trial locations and contacts
1 site in 1 country.
About this study
We aimed to investigate the effects of virtual reality based rehabilitation program on patients with knee osteoarthritis.
Read the detailed description
Sixty volunteer participants with knee osteoarthritis aged 40 to 65 years who were at stage of 2-3 according to the Kellgren Lawrence radiological evaluation were included in the study.
Participants were randomly divided into two groups as virtual and control group. While a conventional physiotherapy program consisting of electrotherapy and exercise program was applied to both groups 5 days a week for 6 weeks, a virtual reality program was added to the virtual group for 6 weeks, 5 days a week. At the beginning of the treatment and at the end of the sixth week, ROM, pain, kinesiophobia, proprioception, balance, muscle strength and functional status were evaluated between groups.
- Conditions
- Knee Osteoarthritis
- Being tested
- Virtual Reality based Rehabilitation Program
- Keywords
- Knee osteoarthritis, Virtual reality, Rehabilitation, Balance, Kinesiophobia
- Medical subject headings
- Osteoarthritis, Knee, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality based Rehabilitation ProgramOther
Virtual reality-based rehabilitation was implemented via MarVAJED system. At first the sensors of MarVAJED® were placed under and above the knee joint and then it was calibrated. The content of the game programs included in the MarVAJED system and how to perform these games with the exercises were explained to the participants. We used games called "Crazy Wings and Blasting Ball" included in the MarVAJED®.There was a bird figure in Crazy Wings game and represented knee joint of participants. Although the bird figure moved upwards during knee flexion, it moved downward in knee extension, there were some obstacles on the way of the bird went. The subjects were asked to follow the bird figure visually and to pass through the obstacles by flexing or extending their knees when they encountered obstacles.
| Study group | Role | What they receive |
|---|---|---|
| Virtual group | Experimental | This virtual realtiy was implemented with MarVAJED® (Marmara Visual Auditory Joint Education Device) system which was developed by Marmara University, Department of Physiotherapy and Rehabilitation, Istanbul,Turkey. MarVAJED® is a system that evaulates the range of motion of the joints, analyzes the sensation of joint position, provides biofeedback support to increase joint control and the same time allows exercises to be controlled. This device analyzes the joint motion with the help of small sensors (Figure 2). The obtained data transfers to your mobile phone, to the tablet or to your personal computer. It stores the data by downloading it to the central server via internet for storage. Receives: Other: Virtual Reality based Rehabilitation Program |
| Control group | Active comparator | Conventional physiotherapy consists of electrotherapy and exercise programs. Hotpack or coldpack, therapeutic ultrasound (US) and conventional TENS were applied as electrotherapy program. Receives: Other: Virtual Reality based Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Balance
PEDALO® Sensamove Balance System was used to evaluate postural balance of subjects.It has a balance board in which consists of sensors to record and process data about balance performance to a computer.
Measured: Change from baseline postural balance at week 6.
Severity of the knee Osteoarthritis
Severity of the knee Osteoarthritis of participants was evaulated with "Western Ontario and McMaster Universities Arthritis" (WOMAC LK 3.1). The WOMAC LK has 24 questions in three subscales (pain , stiffness, physical functions) and a total of 24 questions. Each item is scored 0 to 4. Maxiumum score is 96. the higher the scores indicate that the severity of the disease is worse.
Measured: Change from baseline severity of knee osteoarthritis at week 6.
Kinesiophobia
Kinesiophobia was assessed with TAMPA Scale for Kinesiophobia (TSK). TSK is a 17-item measure that assesses kinesiophobia (fear of movement). Each item is evaluated on a 4-point Likert scale with scoring alternatives ranging from 'strongly disagree' to 'strongly agree. Total scores range from 17 to 68, with higher scores reflecting greater kinesiophobia.
Measured: Change from baseline kinesiophobia at week 6.
Muscle Strength of Knee extensor and flexor Muscles
Muscle Strength was evaulated with Biodex System Pro 4 Isokinetic Dynamometer (Biodex Medical Systems, Inc, Shirley, NY. USA). The subjects were seated in such a position that knee and hip were at 900 flexion, and shoulders, ankle and pelvis were fixed to the machine. The centre of the knee joint was aligned with the centre of the dynamometer by using a laser-pointing device. Before testing, 5-min warming programme was performed by using treadmill. Isokinetic test was performed with 5 repetitions at 1200/s and 2400/s angular velocities. Tests were performed in a standardized order and all subjects have received identical instructions and encouragements.
Measured: Change from baseline muscle strength at week 6.
Knee Pain
Pain was evaulated with VAS (Visual Analog Scale). The VAS consists of a 10 cm straight line which presents a continuum of intensity and has verbal anchors at opposite ends representing 'no pain' at the bottom and 'pain as bad as it can be' at the top. The participants were asked to mark the representing point of their pain levels. The values were recorded in cm .
Measured: Change from baseline knee pain at week 6.
Knee Proprioception
Knee proprioception was evaulated with MarVAJED system (Marmara Visual Auditory Joint Education Device). MarVAJED® is used in virtual rehabilitation and also has test software which can evaluate knee proprioception. The sensors of the system were placed on the upper and lower parts of the knee joint. The subjects were asked to lie down in prone position. The system was calibrated and then the knee joint was passively flexed at 30 degree. Participants were allowed to wait for ten minutes in this position to perceive the degree of knee flexion. Then the knee joint was passively brought back to the initial position and the patients were asked to actively flex their knee at 300 with their eyes closed. The same protocol was performed in 60 degree. . The difference between the reference degree and the degree that the subject performed during the test was automatically calculated by the MarVAJED system.
Measured: Change from baseline knee proprioception at week 6.
Range of Motion (ROM)
The active range of motion of knee (flexion, extension) was assessed by using a universal goniometer. Kendall-McCreary criteria was considered in the assessments. Measurements were repeated three times and the average value was used in the statistical analysis.
Measured: Change from baseline Range of Motion (ROM) at week 6.
Functionality
Functionality of participants was evaulated with Aggregated Locomotor Function (ALF) test. Aggregated Locomotor Function (ALF) test consists of three parts: stair climbing, walk and transfer tests. The time was recorded for each of the tests. longer periods mean that functionality is worse.
Measured: Change baseline from functionality at week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start21 Apr 2018
- Primary completion27 May 2019
- Study completion29 May 2019
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
- Parallel groups
- Model description
- Randomized
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMEL METE, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011553
- Sponsor's protocol ID
- Istanbul Medeniyet University
- Status last verified
- Jul 2019
- First submitted
- 24 Jun 2019
- Last updated
- 8 Jul 2019
- 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 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Virtual Reality Based Rehabilitation in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04011553
- Acronym / sponsor ID
- Istanbul Medeniyet University
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Virtual reality, Rehabilitation, Balance, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 21 Apr 2018 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 8 Jul 2019 (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.
We aimed to investigate the effects of virtual reality based rehabilitation program on patients with knee osteoarthritis.
Detailed description
Sixty volunteer participants with knee osteoarthritis aged 40 to 65 years who were at stage of 2-3 according to the Kellgren Lawrence radiological evaluation were included in the study.
Participants were randomly divided into two groups as virtual and control group. While a conventional physiotherapy program consisting of electrotherapy and exercise program was applied to both groups 5 days a week for 6 weeks, a virtual reality program was added to the virtual group for 6 weeks, 5 days a week. At the beginning of the treatment and at the end of the sixth week, ROM, pain, kinesiophobia, proprioception, balance, muscle strength and functional status were evaluated between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Virtual group | Experimental | Other: Virtual Reality based Rehabilitation ProgramThis virtual realtiy was implemented with MarVAJED® (Marmara Visual Auditory Joint Education Device) system which was developed by Marmara University, Department of Physiotherapy and Rehabilitation, Istanbul,Turkey. MarVAJED® is a system that evaulates the range of motion of the joints, analyzes the sensation of joint position, provides biofeedback support to increase joint control and the same time allows exercises to be controlled. This device analyzes the joint motion with the help of small sensors (Figure 2). The obtained data transfers to your mobile phone, to the tablet or to your personal computer. It stores the data by downloading it to the central server via internet for storage. |
| Control group | Active comparator | Other: Virtual Reality based Rehabilitation ProgramConventional physiotherapy consists of electrotherapy and exercise programs. Hotpack or coldpack, therapeutic ultrasound (US) and conventional TENS were applied as electrotherapy program. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- knee osteoarhritis aged 40 to 75 years who were at stage of 2-3 according to the Kellegren Lawrence radiological evaluation were included in the study.
Key exclusion criteria (9 listed)
- Those who have received physical therapy in the last 6 months
- Having serious systemic and cardiovascular diseases that may prevent exercise
- Neurological and orthopedic problems affecting gait
- Those with sensory defects
- Malignancy diagnosed
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 |
|---|---|---|
| Virtual Reality based Rehabilitation ProgramVirtual reality-based rehabilitation was implemented via MarVAJED system. At first the sensors of MarVAJED® were placed under and above the knee joint and then it was calibrated. The content of the game programs included in the MarVAJED system and how to perform these games with the exercises were explained to the participants. We used games called "Crazy Wings and Blasting Ball" included in the MarVAJED®.There was a bird figure in Crazy Wings game and represented knee joint of participants. Although the bird figure moved upwards during knee flexion, it moved downward in knee extension, there were some obstacles on the way of the bird went. The subjects were asked to follow the bird figure visually and to pass through the obstacles by flexing or extending their knees when they encountered obstacles. | Other | Control group, Virtual group |
Primary outcome
Postural Balance
Time frame: Change from baseline postural balance at week 6.
PEDALO® Sensamove Balance System was used to evaluate postural balance of subjects.It has a balance board in which consists of sensors to record and process data about balance performance to a computer.
Severity of the knee Osteoarthritis
Time frame: Change from baseline severity of knee osteoarthritis at week 6.
Severity of the knee Osteoarthritis of participants was evaulated with "Western Ontario and McMaster Universities Arthritis" (WOMAC LK 3.1). The WOMAC LK has 24 questions in three subscales (pain , stiffness, physical functions) and a total of 24 questions. Each item is scored 0 to 4. Maxiumum score is 96. the higher the scores indicate that the severity of the disease is worse.
Kinesiophobia
Time frame: Change from baseline kinesiophobia at week 6.
Kinesiophobia was assessed with TAMPA Scale for Kinesiophobia (TSK). TSK is a 17-item measure that assesses kinesiophobia (fear of movement). Each item is evaluated on a 4-point Likert scale with scoring alternatives ranging from 'strongly disagree' to 'strongly agree. Total scores range from 17 to 68, with higher scores reflecting greater kinesiophobia.
Muscle Strength of Knee extensor and flexor Muscles
Time frame: Change from baseline muscle strength at week 6.
Muscle Strength was evaulated with Biodex System Pro 4 Isokinetic Dynamometer (Biodex Medical Systems, Inc, Shirley, NY. USA). The subjects were seated in such a position that knee and hip were at 900 flexion, and shoulders, ankle and pelvis were fixed to the machine. The centre of the knee joint was aligned with the centre of the dynamometer by using a laser-pointing device. Before testing, 5-min warming programme was performed by using treadmill. Isokinetic test was performed with 5 repetitions at 1200/s and 2400/s angular velocities. Tests were performed in a standardized order and all subjects have received identical instructions and encouragements.
Knee Pain
Time frame: Change from baseline knee pain at week 6.
Pain was evaulated with VAS (Visual Analog Scale). The VAS consists of a 10 cm straight line which presents a continuum of intensity and has verbal anchors at opposite ends representing 'no pain' at the bottom and 'pain as bad as it can be' at the top. The participants were asked to mark the representing point of their pain levels. The values were recorded in cm .
Knee Proprioception
Time frame: Change from baseline knee proprioception at week 6.
Knee proprioception was evaulated with MarVAJED system (Marmara Visual Auditory Joint Education Device). MarVAJED® is used in virtual rehabilitation and also has test software which can evaluate knee proprioception. The sensors of the system were placed on the upper and lower parts of the knee joint. The subjects were asked to lie down in prone position. The system was calibrated and then the knee joint was passively flexed at 30 degree. Participants were allowed to wait for ten minutes in this position to perceive the degree of knee flexion. Then the knee joint was passively brought back to the initial position and the patients were asked to actively flex their knee at 300 with their eyes closed. The same protocol was performed in 60 degree. . The difference between the reference degree and the degree that the subject performed during the test was automatically calculated by the MarVAJED system.
Range of Motion (ROM)
Time frame: Change from baseline Range of Motion (ROM) at week 6.
The active range of motion of knee (flexion, extension) was assessed by using a universal goniometer. Kendall-McCreary criteria was considered in the assessments. Measurements were repeated three times and the average value was used in the statistical analysis.
Functionality
Time frame: Change baseline from functionality at week 6.
Functionality of participants was evaulated with Aggregated Locomotor Function (ALF) test. Aggregated Locomotor Function (ALF) test consists of three parts: stair climbing, walk and transfer tests. The time was recorded for each of the tests. longer periods mean that functionality is worse.
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 8 Jul 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality based Rehabilitation Program in people with Knee Osteoarthritis, run by Istanbul Medeniyet University 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 1 inclusion and 9 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 8 Jul 2019. 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. 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?
Postural Balance (time frame: Change from baseline postural balance at week 6.). The study lists 8 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 8 Jul 2019.