- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05601947
Investigation of the Effectiveness of Wii-Based Exercise Play Therapy in Knee Osteoarthritis Rehabilitation
Investigation of the Effectiveness of Wii-Based Exercise Play Therapy in Knee
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Güler Büyükyılmaz
- Phone Number: +905544321608
- Email: guler_kb@hotmail.com
Study Contact Backup
- Name: Devrim Tarakçı
- Phone Number: +905322052282
- Email: dtarakci@medipol.edu.tr
Study Locations
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Istanbul, Turkey, 34820
- Recruiting
- Istanbul Medipol University
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Contact:
- Güler Büyükyılmaz
- Phone Number: +905544321608
- Email: guler_kb@hotmail.com
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Contact:
- Devrim Tarakçı
- Phone Number: +905322052282
- Email: dtarakci@medipol.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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,
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Structured Proprioception and Closed Kinetic Chain Exercises Group
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.
|
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.
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Experimental: Wii Based Balance Training Program Group
In addition to electrotherapy and conventional exercise program, wii-based balance training program will be applied 5 days a week for 3 weeks.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 minutes
|
pain threshold
Time Frame: 5 minutes
|
with algometer
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5 minutes
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Normal range of motion
Time Frame: 5 minutes
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Normal range of motion can be measured with goniometer
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5 minutes
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muscle strength
Time Frame: 5 minutes
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muscle strength is measured with a dynamometer
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5 minutes
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proprioception
Time Frame: 10 minutes
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digital goniometer
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10 minutes
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Evaluation of Functional Performance
Time Frame: 5 minutes
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Functional performance was evaluated with the Timed Up and Go Test
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5 minutes
|
Evaluation of Functional Performance
Time Frame: 5 minutes
|
Functional performance was evaluated with the 10-meter walk test
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5 minutes
|
Evaluation of Functional Performance
Time Frame: 5 minutes
|
Functional performance was evaluated with the 10-step climbing test.
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5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional level
Time Frame: 10 minutes
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Western Ontario and McMaster Universities Osteoarthritis Index
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10 minutes
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functional level
Time Frame: 10 minutes
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lequesne knee index
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10 minutes
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postural control
Time Frame: 10 minutes
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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.
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10 minutes
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-65142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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