Knee ArthropathyTKANCT05875324
Effects of Virtual Reality in TKA Patients
A study testing virtual reality application and exercise in people with Knee Arthropathy, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- virtual reality application and exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Oct 2019to 10 Aug 2021
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Pain, Kinesiophobia and Function in Total Knee Arthroplasty Patients
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
Read more
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
- Being tested
- virtual reality application, exercise
- Keywords
- Knee arthroplasty, VR, Exercise, Pain, Kinesiophobia, Catastrophization, Function
- Medical subject headings
- Motor Activity, Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality applicationDevice
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.
exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 4th week after TKA
Secondary outcomes (12)
knee pain assessed by Numerical Pain Rating Scale
The intensity of pain was evaluated by using the Numerical Pain Rating Scale (score between 0-10) (higher values indicate higher pain) at rest, at night and during functional tests (ICC: 0,84).
Measured: first day after TKA
knee pain assessed by Numerical Pain Rating Scale
The intensity of pain was evaluated by using the Numerical Pain Rating Scale (score between 0-10) (higher values indicate higher pain) at rest, at night and during functional tests (ICC: 0,84).
Measured: 4th week after TKA
pain catastrophizing assessed by Pain Catastrophizing Scale
Pain catastrophizing was evaluated by using the Pain Catastrophizing Scale (total score between 0-52) (higher values indicate higher pain catastrophizing). The scores of 30 and above taken from the Pain Catastrophizing Scale indicate the presence of high pain catastrophizing (ICC: 0,83).
Measured: first day after TKA
pain catastrophizing assessed by Pain Catastrophizing Scale
Pain catastrophizing was evaluated by using the Pain Catastrophizing Scale (total score between 0-52) (higher values indicate higher pain catastrophizing). The scores of 30 and above taken from the Pain Catastrophizing Scale indicate the presence of high pain catastrophizing (ICC: 0,83).
Measured: 4th week after TKA
knee range of motion assessed by universal goniometer
ROM was measured with a universal goniometer. Active flexion and extension measurements were performed while the patients were lying in the supine position (ICC: 0.81; ICC: 0.86, respectively). In the knee extension evaluation, cases where 0° could not be reached in the evaluation of knee extension were recorded as positive values, and the degrees of knee extension performed more than the initial position of 0° were recorded as negative values.
Measured: first day after TKA
knee range of motion assessed by universal goniometer
ROM was measured with a universal goniometer. Active flexion and extension measurements were performed while the patients were lying in the supine position (ICC: 0.81; ICC: 0.86, respectively). In the knee extension evaluation, cases where 0° could not be reached in the evaluation of knee extension were recorded as positive values, and the degrees of knee extension performed more than 0° were recorded as negative values.
Measured: 4th week after TKA
objective functional measurement assessed by functional tests
For the Five Times Sit to Stand Test (time-second), subjects were asked to rise from a standard height (43 cm) chair without armrests, five times, as fast as possible with their arms folded (ICC: 0.80).
For the Timed Up and Go Test (time-second), subjects were asked to rise from sitting in an armchair, walk 3 meters, turn, walk back to the chair, then sit down and a walking aid if required (ICC: 0.97).
For the Stair Climb Test (time-second), subjects were asked to ascend steps at the bottom of eight steps (15 cm high, 27.5 cm deep). Subjects could use the handrail if preferred and a walking aid if they normally used one. After a brief rest, the subject was asked to descend the stairs (ICC: 0.93).
Measured: first day after TKA
objective functional measurement assessed by functional tests
For the Five Times Sit to Stand Test (time-second), subjects were asked to rise from a standard height (43 cm) chair without armrests, five times, as fast as possible with their arms folded (ICC: 0.80).
For the Timed Up and Go Test (time-second), subjects were asked to rise from sitting in an armchair, walk 3 meters, turn, walk back to the chair, then sit down and a walking aid if required (ICC: 0.97).
For the Stair Climb Test (time-second), subjects were asked to ascend steps at the bottom of eight steps (15 cm high, 27.5 cm deep). Subjects could use the handrail if preferred and a walking aid if they normally used one. After a brief rest, the subject was asked to descend the stairs (ICC: 0.93).
Measured: 4th week after TKA
subjective functional measurement assessed by Western Ontario and McMaster Universities Osteoarthritis Index
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (total score between 0-96) (higher values indicate worse function) is a disease-specific, self-administered questionnaire developed to study patients with hip or knee OA. It consists of 24 questions, grouped into 3 subscales (pain, stiffness, and physical function). In Likert scale, there are five alternative answers to every question (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). The maximum score in Likert scale scale is 20 points for pain, 8 points for stiffness, and 68 points for physical function (ICC: 0.71-0.94).
Measured: first day after TKA
subjective functional measurement assessed by Western Ontario and McMaster Universities Osteoarthritis Index
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (total score between 0-96) (higher values indicate worse function) is a disease-specific, self-administered questionnaire developed to study patients with hip or knee OA. It consists of 24 questions, grouped into 3 subscales (pain, stiffness, and physical function). In Likert scale, there are five alternative answers to every question (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). The maximum score in Likert scale scale is 20 points for pain, 8 points for stiffness, and 68 points for physical function (ICC: 0.71-0.94).
Measured: 4th week after TKA
quality of life assessed by Short Form 36
Quality of life was evaluated using the Short Form 36 (SF-36) quality of life scale (total score between 0-100 for each subscale) (higher values indicate better health). SF-36 consists of a total of 36 items belonging to 8 different subgroups called physical, social, emotional function, physical role, mental health, fatigue, pain, and general health. An increase in the score indicates better health, while a decrease indicates worse health (Cronbach's Alpha: 0.7324-0.7612).
Measured: first day after TKA
quality of life assessed by Short Form 36
Quality of life was evaluated using the Short Form 36 (SF-36) quality of life scale (total score between 0-100 for each subscale) (higher values indicate better health). SF-36 consists of a total of 36 items belonging to 8 different subgroups called physical, social, emotional function, physical role, mental health, fatigue, pain, and general health. An increase in the score indicates better health, while a decrease indicates worse health (Cronbach's Alpha: 0.7324-0.7612).
Measured: 4th week after TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start13 Oct 2019
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies 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
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Ozan Gür, PT, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875324
- Sponsor's protocol ID
- 611
- Acronym
- TKA
- Status last verified
- May 2023
- First submitted
- 13 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Pain, Kinesiophobia and Function in Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT05875324
- Acronym / sponsor ID
- TKA / 611
- Conditions
- Knee Arthropathy
- Keywords
- Knee arthroplasty, VR, Exercise, Pain, Kinesiophobia, Catastrophization, Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 13 Oct 2019 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 25 May 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Group | Experimental | Device: virtual reality application, Other: exerciseThe 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. |
| Exercise Group | Active comparator | Other: exerciseExercise 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 applicationVR 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. | Device | VR Group |
| exerciseactivities 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. | Other | Exercise Group, VR Group |
Primary outcome
Kinesiophobia assessed by Tampa Kinesiophobia Scale
Time frame: first day after TKA
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).
Kinesiophobia assessed by Tampa Kinesiophobia Scale
Time frame: 4th week after TKA
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).
12 secondary outcomes
knee pain assessed by Numerical Pain Rating Scale
Time frame: first day after TKA
knee pain assessed by Numerical Pain Rating Scale
Time frame: 4th week after TKA
pain catastrophizing assessed by Pain Catastrophizing Scale
Time frame: first day after TKA
pain catastrophizing assessed by Pain Catastrophizing Scale
Time frame: 4th week after TKA
knee range of motion assessed by universal goniometer
Time frame: first day after TKA
knee range of motion assessed by universal goniometer
Time frame: 4th week after TKA
objective functional measurement assessed by functional tests
Time frame: first day after TKA
objective functional measurement assessed by functional tests
Time frame: 4th week after TKA
subjective functional measurement assessed by Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: first day after TKA
subjective functional measurement assessed by Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 4th week after TKA
quality of life assessed by Short Form 36
Time frame: first day after TKA
quality of life assessed by Short Form 36
Time frame: 4th week after TKA
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 25 May 2023.
- Individual participant dataSharing planned: Undecided
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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 application and exercise in people with Knee Arthropathy, run by Kırklareli 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 5 inclusion and 6 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 25 May 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. 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?
Kinesiophobia assessed by Tampa Kinesiophobia Scale (time frame: first day after TKA). 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 25 May 2023.