Knee OsteoarthritisNCT05601947
Investigation of the Effectiveness of Wii-Based Exercise Play Therapy in Knee Osteoarthritis Rehabilitation
A study testing Structured Proprioception and Closed Kinetic Chain Exercises Group and Wii Based Balance Training Program Group in people with Knee Osteoarthritis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is a slowly progressive, chronic and degenerative joint disease frequently seen in the knee and hip joints. OA is not only involved in degenerative changes of cartilage, but can also be a result of capsular hypertrophy, osteophytes, subchondral bone sclerosis, ulcerations, fibrillations. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Structured Proprioception and Closed Kinetic Chain Exercises Group and Wii Based Balance Training Program Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 25 Jan 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with knee pain due to OA for at least 6 months,
- diagnosed with primary OA according to the criteria of the American College of Rheumatology,
- Stage 2-3 knee OA according to the Kellgren-Lawrence classification,
- aged 55-65,
- without any neurological disease
- Individuals who volunteered to participate
- Patients with a Mini Mental State Scale score ≥23
Who cannot join
- Diagnosed with secondary OA,
- Patients who have undergone surgery to the knee, hip and/or spine,
- Severe knee trauma
- Have had physical therapy for the knee in the past year
- Presence of neurological disease that may affect balance and proprioception,
- Vertigo, hearing and vision problems,
Show all 9Show fewer
- Genu varum and Genu valgum and Individuals with scoliosis,
- Patients with a body Mass Index (BMI) ≥40 kg/m2
- Patients with a visual analog scale ≥8/10
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Wii-Based Exercise Play Therapy in Knee
Osteoarthritis (OA) is a slowly progressive, chronic and degenerative joint disease frequently seen in the knee and hip joints. OA is not only involved in degenerative changes of cartilage, but can also be a result of capsular hypertrophy, osteophytes, subchondral bone sclerosis, ulcerations, fibrillations. It progressively impairs the patient's independence, mobility and participation in social life, thus reducing the overall quality of life. Edema, stiffness, instability, decreased muscle strength, impaired range of motion and proprioceptive sensation, increased incidence of falls are seen together with the main symptom of pain. In OA, treatment options are available to manage symptoms and optimize quality of life. In clinical guidelines, evidence-based treatment for Osteoarthritis may include patient education and self-management programs that integrate weight management, structured exercise, and physical activity. Closed kinetic chain exercises have gained importance in the rehabilitation of many musculoskeletal problems in the last 20 years and have become one of the most preferred exercises. In addition, the virtual reality treatment approach, which is the most common example of technology use in rehabilitation, has also started to take place in rehabilitation studies. The aim of this project is to investigate the effects of Wii-based video-based exercise game therapy on muscle strength, proprioception, postural control and functional level in knee osteoarthritis rehabilitation.
Read the detailed description
Osteoarthritis (OA) is a slowly progressive, chronic and degenerative joint disease frequently seen in the knee and hip joints. OA is not only involved in degenerative changes of cartilage, but can also be a result of capsular hypertrophy, osteophytes, subchondral bone sclerosis, ulcerations, fibrillations. It progressively impairs the patient's independence, mobility and participation in social life, thus reducing the overall quality of life. Edema, stiffness, instability, decreased muscle strength, impaired range of motion and proprioceptive sensation, increased incidence of falls are seen together with the main symptom of pain. In OA, treatment options are available to manage symptoms and optimize quality of life. In clinical guidelines, evidence-based treatment for Osteoarthritis may include patient education and self-management programs that integrate weight management, structured exercise, and physical activity. Closed kinetic chain exercises have gained importance in the rehabilitation of many musculoskeletal problems in the last 20 years and have become one of the most preferred exercises. In addition, the virtual reality treatment approach, which is the most common example of technology use in rehabilitation, has also started to take place in rehabilitation studies. The aim of this project is to investigate the effects of Wii-based video-based exercise game therapy on muscle strength, proprioception, postural control and functional level in knee osteoarthritis rehabilitation.
Method: 56 volunteers diagnosed with bilateral knee OA, who underwent routine electrotherapy and conventional exercise program in the laboratory of Istanbul Rumeli University and were directed to exercise according to the inclusion criteria, will be included in the study. Patients with knee pain due to OA for at least 6 months, diagnosed with primary OA according to the criteria of the American College of Rheumatology, Stage 2-3 knee OA according to the Kellgren-Lawrence classification, aged 55-65, without any neurological disease Individuals who volunteered to participate and had a Mini Mental State Scale score ≥23 will be included. Diagnosed with secondary OA, Operated on the knee, hip and/or spine, Severe knee trauma or physical therapy for the knee in the last year, Presence of neurological disease that may affect balance and proprioception, Vertigo, hearing and vision problems, Genu varum and Genu valgum and Individuals with scoliosis, Body Mass Index (BMI) ≥40 kg/m2 and Visual analog scale ≥8/10 will be excluded from the study. Pain with Visual Analog Scale, pain threshold with algometer, range of motion with goniometer, muscle strength with dynamometer, functional level with Western Ontario and McMaster Universities Osteoarthritis Index and Lequesne knee index, postural control with Berg balance scale, functional performance with timed get up and go test, 10 meters walking test and 10 steps climbing test, and proprioception with digital goniometer will be evaluated for all participants before and after treatment and at the 8th week of treatment. All individuals participating in the study will be randomly divided into 2 groups. All individuals participating in the study will receive 15 sessions of electrotherapy and conventional exercise program, 5 days a week for 3 weeks. In the first group, besides electrotherapy and conventional exercise program applications, structured proprioception and closed kinetic chain exercises will be applied for 3 weeks under the supervision of a physiotherapist. A rest period of 10 seconds will be given between exercises. The second group will be given a wii-based balance training program for 3 weeks, 5 days a week, in addition to the electrotherapy and conventional exercise program. It was aimed to find an effective treatment method in individuals with knee osteoarthritis by comparing the groups at the end of the treatment and at the 8th week.
- Conditions
- Knee Osteoarthritis
- Being tested
- Structured Proprioception and Closed Kinetic Chain Exercises Group, Wii Based Balance Training Program Group
- Keywords
- Virtual Reality, Exercise, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Proprioception and Closed Kinetic Chain Exercises GroupOther
In this group, an exercise program consisting of 3 stages, ranging from simple to difficult and including closed kinetic chain exercises and proprioceptive exercises, will be applied.
Wii Based Balance Training Program GroupOther
In addition to electrotherapy and conventional exercise program, wii-based balance training program will be applied 5 days a week for 3 weeks. "Balance Surf", which includes lateral weight transfer, "Balance Adventure", which includes versatile balance exercises, and "balance bowling" for static and dynamic postural control will be implemented in the Fizyosoft Balance System. Each game will be practiced under the supervision of a physiotherapist for a total of 3 minutes, respectively, Balance surf, Balance adventure, Balance surf, Balance bowling and Balance surf, for a total of 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Structured Proprioception and Closed Kinetic Chain Exercises Group | Experimental | In addition to electrotherapy and conventional exercise program applications, structured proprioception and closed kinetic chain exercises will be applied for 3 weeks under the supervision of a physiotherapist. A rest period of 10 seconds will be given between exercises. Receives: Other: Structured Proprioception and Closed Kinetic Chain Exercises Group |
| Wii Based Balance Training Program Group | Experimental | In addition to electrotherapy and conventional exercise program, wii-based balance training program will be applied 5 days a week for 3 weeks. Receives: Other: Wii Based Balance Training Program Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 5 minutes
pain threshold
with algometer
Measured: 5 minutes
Normal range of motion
Normal range of motion can be measured with goniometer
Measured: 5 minutes
muscle strength
muscle strength is measured with a dynamometer
Measured: 5 minutes
proprioception
digital goniometer
Measured: 10 minutes
Evaluation of Functional Performance
Functional performance was evaluated with the Timed Up and Go Test
Measured: 5 minutes
Evaluation of Functional Performance
Functional performance was evaluated with the 10-meter walk test
Measured: 5 minutes
Evaluation of Functional Performance
Functional performance was evaluated with the 10-step climbing test.
Measured: 5 minutes
Secondary outcomes (3)
functional level
Western Ontario and McMaster Universities Osteoarthritis Index
Measured: 10 minutes
functional level
lequesne knee index
Measured: 10 minutes
postural control
The Berg Balance Scale (BBS) consists of 14 different questions that evaluate the maintenance of the static position during changes in the orientation of the body center of gravity. Scoring is made between 0-4. In this scoring, 4 points represent the activity without any support, while 0 points represent full support or not performing the activity at all. The highest total score is 56 and reflects perfect balance.If the patient scores between 0-20 points, she is considered wheelchair dependent.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Nov 2022
- Primary completion15 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gulerbuyukyilmaz, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601947
- Sponsor's protocol ID
- E-10840098-772.02-65142
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will publish my manuscript about this study, so researchers can access my individual participant data with this way.
Publications
Manlapaz DG, Sole G, Jayakaran P, Chapple CM. Exergaming to improve balance and decrease the risk of falling in adults with knee osteoarthritis: a mixed-methods feasibility study. Physiother Theory Pract. 2022 Nov;38(13):2428-2440. doi: 10.1080/09593985.2021.1952670. Epub 2021 Jul 19.
PubMed 34280069
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Wii-Based Exercise Play Therapy in Knee
- ClinicalTrials.gov ID
- NCT05601947
- Acronym / sponsor ID
- E-10840098-772.02-65142
- Conditions
- Knee Osteoarthritis
- Keywords
- Virtual Reality, Exercise, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 1 Nov 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.
Osteoarthritis (OA) is a slowly progressive, chronic and degenerative joint disease frequently seen in the knee and hip joints. OA is not only involved in degenerative changes of cartilage, but can also be a result of capsular hypertrophy, osteophytes, subchondral bone sclerosis, ulcerations, fibrillations. It progressively impairs the patient's independence, mobility and participation in social life, thus reducing the overall quality of life. Edema, stiffness, instability, decreased muscle strength, impaired range of motion and proprioceptive sensation, increased incidence of falls are seen together with the main symptom of pain. In OA, treatment options are available to manage symptoms and optimize quality of life. In clinical guidelines, evidence-based treatment for Osteoarthritis may include patient education and self-management programs that integrate weight management, structured exercise, and physical activity. Closed kinetic chain exercises have gained importance in the rehabilitation of many musculoskeletal problems in the last 20 years and have become one of the most preferred exercises. In addition, the virtual reality treatment approach, which is the most common example of technology use in rehabilitation, has also started to take place in rehabilitation studies. The aim of this project is to investigate the effects of Wii-based video-based exercise game therapy on muscle strength, proprioception, postural control and functional level in knee osteoarthritis rehabilitation.
Detailed description
Osteoarthritis (OA) is a slowly progressive, chronic and degenerative joint disease frequently seen in the knee and hip joints. OA is not only involved in degenerative changes of cartilage, but can also be a result of capsular hypertrophy, osteophytes, subchondral bone sclerosis, ulcerations, fibrillations. It progressively impairs the patient's independence, mobility and participation in social life, thus reducing the overall quality of life. Edema, stiffness, instability, decreased muscle strength, impaired range of motion and proprioceptive sensation, increased incidence of falls are seen together with the main symptom of pain. In OA, treatment options are available to manage symptoms and optimize quality of life. In clinical guidelines, evidence-based treatment for Osteoarthritis may include patient education and self-management programs that integrate weight management, structured exercise, and physical activity. Closed kinetic chain exercises have gained importance in the rehabilitation of many musculoskeletal problems in the last 20 years and have become one of the most preferred exercises. In addition, the virtual reality treatment approach, which is the most common example of technology use in rehabilitation, has also started to take place in rehabilitation studies. The aim of this project is to investigate the effects of Wii-based video-based exercise game therapy on muscle strength, proprioception, postural control and functional level in knee osteoarthritis rehabilitation.
Method: 56 volunteers diagnosed with bilateral knee OA, who underwent routine electrotherapy and conventional exercise program in the laboratory of Istanbul Rumeli University and were directed to exercise according to the inclusion criteria, will be included in the study. Patients with knee pain due to OA for at least 6 months, diagnosed with primary OA according to the criteria of the American College of Rheumatology, Stage 2-3 knee OA according to the Kellgren-Lawrence classification, aged 55-65, without any neurological disease Individuals who volunteered to participate and had a Mini Mental State Scale score ≥23 will be included. Diagnosed with secondary OA, Operated on the knee, hip and/or spine, Severe knee trauma or physical therapy for the knee in the last year, Presence of neurological disease that may affect balance and proprioception, Vertigo, hearing and vision problems, Genu varum and Genu valgum and Individuals with scoliosis, Body Mass Index (BMI) ≥40 kg/m2 and Visual analog scale ≥8/10 will be excluded from the study. Pain with Visual Analog Scale, pain threshold with algometer, range of motion with goniometer, muscle strength with dynamometer, functional level with Western Ontario and McMaster Universities Osteoarthritis Index and Lequesne knee index, postural control with Berg balance scale, functional performance with timed get up and go test, 10 meters walking test and 10 steps climbing test, and proprioception with digital goniometer will be evaluated for all participants before and after treatment and at the 8th week of treatment. All individuals participating in the study will be randomly divided into 2 groups. All individuals participating in the study will receive 15 sessions of electrotherapy and conventional exercise program, 5 days a week for 3 weeks. In the first group, besides electrotherapy and conventional exercise program applications, structured proprioception and closed kinetic chain exercises will be applied for 3 weeks under the supervision of a physiotherapist. A rest period of 10 seconds will be given between exercises. The second group will be given a wii-based balance training program for 3 weeks, 5 days a week, in addition to the electrotherapy and conventional exercise program. It was aimed to find an effective treatment method in individuals with knee osteoarthritis by comparing the groups at the end of the treatment and at the 8th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Proprioception and Closed Kinetic Chain Exercises Group | Experimental | Other: Structured Proprioception and Closed Kinetic Chain Exercises GroupIn addition to electrotherapy and conventional exercise program applications, structured proprioception and closed kinetic chain exercises will be applied for 3 weeks under the supervision of a physiotherapist. A rest period of 10 seconds will be given between exercises. |
| Wii Based Balance Training Program Group | Experimental | Other: Wii Based Balance Training Program GroupIn addition to electrotherapy and conventional exercise program, wii-based balance training program will be applied 5 days a week for 3 weeks. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with knee pain due to OA for at least 6 months,
- diagnosed with primary OA according to the criteria of the American College of Rheumatology,
- Stage 2-3 knee OA according to the Kellgren-Lawrence classification,
- aged 55-65,
- without any neurological disease
Key exclusion criteria (9 listed)
- Diagnosed with secondary OA,
- Patients who have undergone surgery to the knee, hip and/or spine,
- Severe knee trauma
- Have had physical therapy for the knee in the past year
- Presence of neurological disease that may affect balance and proprioception,
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 |
|---|---|---|
| Structured Proprioception and Closed Kinetic Chain Exercises GroupIn this group, an exercise program consisting of 3 stages, ranging from simple to difficult and including closed kinetic chain exercises and proprioceptive exercises, will be applied. | Other | Structured Proprioception and Closed Kinetic Chain Exercises Group |
| Wii Based Balance Training Program GroupIn addition to electrotherapy and conventional exercise program, wii-based balance training program will be applied 5 days a week for 3 weeks. "Balance Surf", which includes lateral weight transfer, "Balance Adventure", which includes versatile balance exercises, and "balance bowling" for static and dynamic postural control will be implemented in the Fizyosoft Balance System. Each game will be practiced under the supervision of a physiotherapist for a total of 3 minutes, respectively, Balance surf, Balance adventure, Balance surf, Balance bowling and Balance surf, for a total of 15 minutes. | Other | Wii Based Balance Training Program Group |
Primary outcome
VAS
Time frame: 5 minutes
The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
pain threshold
Time frame: 5 minutes
with algometer
Normal range of motion
Time frame: 5 minutes
Normal range of motion can be measured with goniometer
muscle strength
Time frame: 5 minutes
muscle strength is measured with a dynamometer
proprioception
Time frame: 10 minutes
digital goniometer
Evaluation of Functional Performance
Time frame: 5 minutes
Functional performance was evaluated with the Timed Up and Go Test
Evaluation of Functional Performance
Time frame: 5 minutes
Functional performance was evaluated with the 10-meter walk test
Evaluation of Functional Performance
Time frame: 5 minutes
Functional performance was evaluated with the 10-step climbing test.
3 secondary outcomes
functional level
Time frame: 10 minutes
functional level
Time frame: 10 minutes
postural control
Time frame: 10 minutes
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 Mar 2023.
- Results publication: PubMed 34280069Manlapaz DG, Sole G, Jayakaran P, Chapple CM. Exergaming to improve balance and decrease the risk of falling in adults with knee osteoarthritis: a mixed-methods feasibility study. Physiother Theory Pract. 2022 Nov;38(13):2428-2440. doi: 10.1080/09593985.2021.1952670. Epub 2021 Jul 19.
- Individual participant dataSharing planned: No. I will publish my manuscript about this study, so researchers can access my individual participant data with this way.
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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 Structured Proprioception and Closed Kinetic Chain Exercises Group and Wii Based Balance Training Program Group in people with Knee Osteoarthritis, run by Istanbul Medipol University Hospital 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 7 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 Mar 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?
VAS (time frame: 5 minutes). 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?
On the ClinicalTrials.gov record for NCT05601947, which also lists 1 linked publication.
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 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.