Gamification in Knee Replacement Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Gamification in Knee Replacement Rehabilitation. Randomized Controlled Trial and Qualitative Approach

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Exergame
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exergame<br>Home-based exergame intervention and usual treatment. | Other: Exergame<br>* 16-week home-based exercise intervention with exergaming system and usual treatment.<br>* Other names: Gamified rehabilitation;|
| Experimental: Control<br>Home-exercise by standard protocol and usual treatment. | Other: Control<br>* 16-week home-based exercise by standard protocol and usual treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Function and pain related to knee | Oxford Knee Score | Change from pre-operative baseline at 2 and 4 months post-operative. | 
| Change in Mobility | Timed Up and Go | Change from pre-operative baseline at 2 and 4 months post-operative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Function and pain related to knee | Oxford knee score | Change from pre-operative baseline at 12 months post-operative. | 
| Change in Mobility | Timed Up and Go | Change from pre-operative baseline at 12 months post-operative. | 
| Change in Walking | 10-m Walking speed | pre-operative baseline and 2, 4 and 12 months post-operative | 
| Change in Lower extremity performance | Short Physical Performance Battery | pre-operative baseline and 2, 4 and 12 months post-operative | 
| Change in Muscle strength | Isometric knee extension and flexion strength | pre-operative baseline and 2, 4 and 12 months post-operative | 
| Change in Knee range of motion | Goniometer | pre-operative baseline and 2, 4 and 12 months post-operative | 
| Change in knee pain (VAS) | Visual analogue scale (0 to 100 mm), Constant score (0 to 100 points) | pre-operative baseline and 2, 4 and 12 months post-operative | 
| Change in Disability | WHO disability scale (WHODAS 2.0.) | pre-operative baseline and 2, 4 and 12 months post-operative | 
| Change in Pain | Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on pain. | pre-operative baseline and 2, 4 and 12 months post-operative | 
| Change in other symptoms such as swelling, restricted range of motion and mechanical symptoms | Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on symptoms | pre-operative baseline and 2, 4 and 12 months post-operative | 
| Change in quality of life (QOL) | Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on QOL | pre-operative baseline and 2, 4 and 12 months post-operative | 
| Change in activities of daily living (ADL) Function | Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on ADL | pre-operative baseline and 2, 4 and 12 months post-operative | 
| Change in Sport and Recreation Function | Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on Sport and Recreation Function | pre-operative baseline and 2, 4 and 12 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee replacement, Exergame, Total knee arthroplasty, Exercise, Physiotherapy, Physical functioning