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Investigation of the Effectiveness of Wii-Based Exercise Play Therapy in Knee Osteoarthritis Rehabilitation

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Structured Proprioception and Closed Kinetic Chain Exercises Group
Wii Based Balance Training Program Group
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Virtual Reality, Exercise, Knee Osteoarthritis

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Structured Proprioception and Closed Kinetic Chain Exercises Group

Wii Based Balance Training Program Group

Arm Description

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 addition to electrotherapy and conventional exercise program, wii-based balance training program will be applied 5 days a week for 3 weeks.

Outcomes

Primary Outcome Measures

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.
pain threshold
with algometer
Normal range of motion
Normal range of motion can be measured with goniometer
muscle strength
muscle strength is measured with a dynamometer
proprioception
digital goniometer
Evaluation of Functional Performance
Functional performance was evaluated with the Timed Up and Go Test
Evaluation of Functional Performance
Functional performance was evaluated with the 10-meter walk test
Evaluation of Functional Performance
Functional performance was evaluated with the 10-step climbing test.

Secondary Outcome Measures

functional level
Western Ontario and McMaster Universities Osteoarthritis Index
functional level
lequesne knee index
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.

Full Information

First Posted
October 25, 2022
Last Updated
March 7, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05601947
Brief Title
Investigation of the Effectiveness of Wii-Based Exercise Play Therapy in Knee Osteoarthritis Rehabilitation
Official Title
Investigation of the Effectiveness of Wii-Based Exercise Play Therapy in Knee
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Virtual Reality, Exercise, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured Proprioception and Closed Kinetic Chain Exercises Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wii Based Balance Training Program Group
Arm Type
Experimental
Arm Description
In addition to electrotherapy and conventional exercise program, wii-based balance training program will be applied 5 days a week for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Structured Proprioception and Closed Kinetic Chain Exercises Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Wii Based Balance Training Program Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
VAS
Description
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.
Time Frame
5 minutes
Title
pain threshold
Description
with algometer
Time Frame
5 minutes
Title
Normal range of motion
Description
Normal range of motion can be measured with goniometer
Time Frame
5 minutes
Title
muscle strength
Description
muscle strength is measured with a dynamometer
Time Frame
5 minutes
Title
proprioception
Description
digital goniometer
Time Frame
10 minutes
Title
Evaluation of Functional Performance
Description
Functional performance was evaluated with the Timed Up and Go Test
Time Frame
5 minutes
Title
Evaluation of Functional Performance
Description
Functional performance was evaluated with the 10-meter walk test
Time Frame
5 minutes
Title
Evaluation of Functional Performance
Description
Functional performance was evaluated with the 10-step climbing test.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
functional level
Description
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame
10 minutes
Title
functional level
Description
lequesne knee index
Time Frame
10 minutes
Title
postural control
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34820
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I will publish my manuscript about this study, so researchers can access my individual participant data with this way.
Citations:
PubMed Identifier
34280069
Citation
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.
Results Reference
result

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Investigation of the Effectiveness of Wii-Based Exercise Play Therapy in Knee Osteoarthritis Rehabilitation

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