Gamification in Knee Replacement Rehabilitation (BEE-RCT)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Exergame
Control
Sponsored by

About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total knee replacement, Exergame, Total knee arthroplasty, Exercise, Physiotherapy, Physical functioning
Eligibility Criteria
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
Sites / Locations
- Central Finland Central Hospital
- University of Jyväskylä
- Turku University Hospital
- Turku University of Applied Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Exergame
Control
Arm Description
Home-based exergame intervention and usual treatment.
Home-exercise by standard protocol and usual treatment.
Outcomes
Primary Outcome Measures
Change in Function and pain related to knee
Oxford Knee Score
Change in Mobility
Timed Up and Go
Secondary Outcome Measures
Change in Function and pain related to knee
Oxford knee score
Change in Mobility
Timed Up and Go
Change in Walking
10-m Walking speed
Change in Lower extremity performance
Short Physical Performance Battery
Change in Muscle strength
Isometric knee extension and flexion strength
Change in Knee range of motion
Goniometer
Change in knee pain (VAS)
Visual analogue scale (0 to 100 mm), Constant score (0 to 100 points)
Change in Disability
WHO disability scale (WHODAS 2.0.)
Change in Pain
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on pain.
Change in other symptoms such as swelling, restricted range of motion and mechanical symptoms
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on symptoms
Change in quality of life (QOL)
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on QOL
Change in activities of daily living (ADL) Function
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on ADL
Change in Sport and Recreation Function
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on Sport and Recreation Function
Full Information
NCT ID
NCT03717727
First Posted
October 8, 2018
Last Updated
July 10, 2023
Sponsor
University of Jyvaskyla
Collaborators
Turku University Hospital, Turku University of Applied Sciences, Jyväskylä Central Hospital, University of Oulu
1. Study Identification
Unique Protocol Identification Number
NCT03717727
Brief Title
Gamification in Knee Replacement Rehabilitation
Acronym
BEE-RCT
Official Title
Effectiveness of Gamification in Knee Replacement Rehabilitation. Randomized Controlled Trial and Qualitative Approach
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
March 24, 2021 (Actual)
Study Completion Date
January 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Jyvaskyla
Collaborators
Turku University Hospital, Turku University of Applied Sciences, Jyväskylä Central Hospital, University of Oulu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total knee replacement, Exergame, Total knee arthroplasty, Exercise, Physiotherapy, Physical functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exergame
Arm Type
Experimental
Arm Description
Home-based exergame intervention and usual treatment.
Arm Title
Control
Arm Type
Experimental
Arm Description
Home-exercise by standard protocol and usual treatment.
Intervention Type
Other
Intervention Name(s)
Exergame
Other Intervention Name(s)
Gamified rehabilitation
Intervention Description
16-week home-based exercise intervention with exergaming system and usual treatment.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
16-week home-based exercise by standard protocol and usual treatment.
Primary Outcome Measure Information:
Title
Change in Function and pain related to knee
Description
Oxford Knee Score
Time Frame
Change from pre-operative baseline at 2 and 4 months post-operative.
Title
Change in Mobility
Description
Timed Up and Go
Time Frame
Change from pre-operative baseline at 2 and 4 months post-operative.
Secondary Outcome Measure Information:
Title
Change in Function and pain related to knee
Description
Oxford knee score
Time Frame
Change from pre-operative baseline at 12 months post-operative.
Title
Change in Mobility
Description
Timed Up and Go
Time Frame
Change from pre-operative baseline at 12 months post-operative.
Title
Change in Walking
Description
10-m Walking speed
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Title
Change in Lower extremity performance
Description
Short Physical Performance Battery
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Title
Change in Muscle strength
Description
Isometric knee extension and flexion strength
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Title
Change in Knee range of motion
Description
Goniometer
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Title
Change in knee pain (VAS)
Description
Visual analogue scale (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Title
Change in Disability
Description
WHO disability scale (WHODAS 2.0.)
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Title
Change in Pain
Description
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on pain.
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Title
Change in other symptoms such as swelling, restricted range of motion and mechanical symptoms
Description
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on symptoms
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Title
Change in quality of life (QOL)
Description
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on QOL
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Title
Change in activities of daily living (ADL) Function
Description
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on ADL
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Title
Change in Sport and Recreation Function
Description
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on Sport and Recreation Function
Time Frame
pre-operative baseline and 2, 4 and 12 months post-operative
Other Pre-specified Outcome Measures:
Title
Physical activity
Description
Physical activity diary
Time Frame
Through study completion, an average of 1 year
Title
Satisfaction with the operated knee
Description
Questionnaire
Time Frame
2, 4 and 12 months post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keijo Mäkelä
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ari Heinonen
Organizational Affiliation
University of Jyvaskyla
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Finland Central Hospital
City
Jyväskylä
Country
Finland
Facility Name
University of Jyväskylä
City
Jyväskylä
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Facility Name
Turku University of Applied Sciences
City
Turku
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
36441574
Citation
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.
Results Reference
background
PubMed Identifier
36896366
Citation
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.
Results Reference
result
Links:
URL
https://bmjopensem.bmj.com/content/9/1/e001416
Description
Primary results
URL
https://www.researchprotocols.org/2022/11/e38434/
Description
Study protocol
Available IPD and Supporting Information:
Available IPD/Information Type
Metadata
Available IPD/Information URL
https://doi.org/10.17011/jyx/dataset/85350
Available IPD/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)
Learn more about this trial
Gamification in Knee Replacement Rehabilitation
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