Gamification in Knee Replacement Rehabilitation (BEE-RCT)
July 10, 2023 updated by: University of Jyvaskyla
Effectiveness of Gamification in Knee Replacement Rehabilitation. Randomized Controlled Trial and Qualitative Approach
After total knee arthroplasty (TKA), knee is usually swollen, painful, and stiff. The main goal of post-operative physical rehabilitation is to achieve full extension and flexion of the knee to avoid contractures and stiffness. Also strengthening of quadriceps muscle and balance to help activities of daily living and overall mobility are important. The post-operative knee replacement rehabilitation includes the standard protocol in hospital phase and the standard home exercise instructions. Computer based exercising games (exergames) may be new method to increase training adherence and volume after TKA and thus improve results and effectiveness of the rehabilitation. However, evidence of effectiveness of rehabilitative exergaming on physical functioning is sparse and more research is needed to conduct evidence-based rehabilitation practices.
Therefore the present study examines the effectiveness of a 16-week gamified physiotherapy on physical functioning, life satisfaction and pain for patients after TKA compared to treatment as usual home exercise. The second objective is to validate the psychometric properties of WHODAS 2.0 (WHO Disability Assessment Schedule) and brief ICF (International classification of functioning, disability and health) core set of osteoarthritis questionnaire. Other objectives are to find out, what kind of understanding and experiences the participants have about the rehabilitation with exergames and to evaluate the usability and user experience of exergames.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jyväskylä, Finland
- Central Finland Central Hospital
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Jyväskylä, Finland
- University of Jyväskylä
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Turku, Finland
- Turku University Hospital
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Turku, Finland
- Turku University of Applied Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- first primary (M17.0, M17.1) unilateral TKA
- mechanical axis of the limb in varus
- model of the TKA is posterior stabilizing (PS) or cruciate retaining (CR) prosthesis
- normal vision with or without eyeglasses
Exclusion Criteria:
- fractures, rheumatoid arthritis, or other biomechanical disruptions in affected lower limb within one year before operation
- diagnosed memory disorder or cognitive impairment
- neurological condition as Parkinson's disease, multiple sclerosis or stroke
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Exergame
Home-based exergame intervention and usual treatment.
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16-week home-based exercise intervention with exergaming system and usual treatment.
Other Names:
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Experimental: Control
Home-exercise by standard protocol and usual treatment.
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16-week home-based exercise by standard protocol and usual treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Function and pain related to knee
Time Frame: Change from pre-operative baseline at 2 and 4 months post-operative.
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Oxford Knee Score
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Change from pre-operative baseline at 2 and 4 months post-operative.
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Change in Mobility
Time Frame: Change from pre-operative baseline at 2 and 4 months post-operative.
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Timed Up and Go
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Change from pre-operative baseline at 2 and 4 months post-operative.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Function and pain related to knee
Time Frame: Change from pre-operative baseline at 12 months post-operative.
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Oxford knee score
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Change from pre-operative baseline at 12 months post-operative.
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Change in Mobility
Time Frame: Change from pre-operative baseline at 12 months post-operative.
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Timed Up and Go
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Change from pre-operative baseline at 12 months post-operative.
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Change in Walking
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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10-m Walking speed
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pre-operative baseline and 2, 4 and 12 months post-operative
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Change in Lower extremity performance
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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Short Physical Performance Battery
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pre-operative baseline and 2, 4 and 12 months post-operative
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Change in Muscle strength
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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Isometric knee extension and flexion strength
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pre-operative baseline and 2, 4 and 12 months post-operative
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Change in Knee range of motion
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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Goniometer
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pre-operative baseline and 2, 4 and 12 months post-operative
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Change in knee pain (VAS)
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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Visual analogue scale (0 to 100 mm), Constant score (0 to 100 points)
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pre-operative baseline and 2, 4 and 12 months post-operative
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Change in Disability
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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WHO disability scale (WHODAS 2.0.)
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pre-operative baseline and 2, 4 and 12 months post-operative
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Change in Pain
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on pain.
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pre-operative baseline and 2, 4 and 12 months post-operative
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Change in other symptoms such as swelling, restricted range of motion and mechanical symptoms
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on symptoms
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pre-operative baseline and 2, 4 and 12 months post-operative
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Change in quality of life (QOL)
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on QOL
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pre-operative baseline and 2, 4 and 12 months post-operative
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Change in activities of daily living (ADL) Function
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on ADL
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pre-operative baseline and 2, 4 and 12 months post-operative
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Change in Sport and Recreation Function
Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative
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Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on Sport and Recreation Function
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pre-operative baseline and 2, 4 and 12 months post-operative
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: Through study completion, an average of 1 year
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Physical activity diary
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Through study completion, an average of 1 year
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Satisfaction with the operated knee
Time Frame: 2, 4 and 12 months post-operative
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Questionnaire
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2, 4 and 12 months post-operative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Keijo Mäkelä, Turku University Hospital
- Principal Investigator: Ari Heinonen, University of Jyväskylä
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Aartolahti E, Janhunen M, Katajapuu N, Paloneva J, Pamilo K, Oksanen A, Keemu H, Karvonen M, Luimula M, Korpelainen R, Jamsa T, Makela K, Heinonen A. Effectiveness of Gamification in Knee Replacement Rehabilitation: Protocol for a Randomized Controlled Trial With a Qualitative Approach. JMIR Res Protoc. 2022 Nov 28;11(11):e38434. doi: 10.2196/38434.
- Janhunen M, Katajapuu N, Paloneva J, Pamilo K, Oksanen A, Keemu H, Karvonen M, Luimula M, Korpelainen R, Jamsa T, Kautiainen H, Makela K, Heinonen A, Aartolahti E. Effects of a home-based, exergaming intervention on physical function and pain after total knee replacement in older adults: a randomised controlled trial. BMJ Open Sport Exerc Med. 2023 Mar 3;9(1):e001416. doi: 10.1136/bmjsem-2022-001416. eCollection 2023.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2018
Primary Completion (Actual)
March 24, 2021
Study Completion (Actual)
January 17, 2022
Study Registration Dates
First Submitted
October 8, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (Actual)
October 24, 2018
Study Record Updates
Last Update Posted (Actual)
July 12, 2023
Last Update Submitted That Met QC Criteria
July 10, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T226/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Sensitive parts of the data cannot be anonymized and thus cannot be openly published.
Sensitive data will be stored in JYX (Jyväskylä University Digital Repository), only the metadata will be public, and access to the data can be requested and granted on certain conditions.
Metadata published in the Jyväskylä University Digital Repository.
Heinonen A, Janhunen M, Aarto-lahti E, et al.
Metadata from: Gamification in Knee Replacement Rehabilitation (BEE-RCT).
V.2.2.2023 doi:10.17011/jyx/dataset/85350
Study Data/Documents
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Metadata
Information comments: Metadata published in the Jyväskylä University Digital Repository. Heinonen A, Janhunen M, Aartolahti E, et al. Metadata from: Gamification in Knee Replacement Rehabilitation (BEE-RCT)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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