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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, 34820

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05601947
Study groupRoleWhat they receive
Structured Proprioception and Closed Kinetic Chain Exercises GroupExperimentalIn 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 GroupExperimentalIn 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.

  1. 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

  2. pain threshold

    with algometer

    Measured: 5 minutes

  3. Normal range of motion

    Normal range of motion can be measured with goniometer

    Measured: 5 minutes

  4. muscle strength

    muscle strength is measured with a dynamometer

    Measured: 5 minutes

  5. proprioception

    digital goniometer

    Measured: 10 minutes

  6. Evaluation of Functional Performance

    Functional performance was evaluated with the Timed Up and Go Test

    Measured: 5 minutes

  7. Evaluation of Functional Performance

    Functional performance was evaluated with the 10-meter walk test

    Measured: 5 minutes

  8. Evaluation of Functional Performance

    Functional performance was evaluated with the 10-step climbing test.

    Measured: 5 minutes

Secondary outcomes (3)
  1. functional level

    Western Ontario and McMaster Universities Osteoarthritis Index

    Measured: 10 minutes

  2. functional level

    lequesne knee index

    Measured: 10 minutes

  3. 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.

  1. First posted1 Nov 2022
  2. Study start1 Nov 2022
  3. Primary completion15 Jan 2023
  4. Study completion25 Jan 2023

Resources

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)
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

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.

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