Clinical trial NCT03717727: Gamification in Knee Replacement Rehabilitation
Official title: Effectiveness of Gamification in Knee Replacement Rehabilitation. Randomized Controlled Trial and Qualitative Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total knee replacement
Exergame
Total knee arthroplasty
Exercise
Physiotherapy
Physical functioning
Lead sponsor: University of Jyvaskyla
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Turku University of Applied Sciences
name: Jyväskylä Central Hospital
name: University of Oulu
First posted: 2018-10-24
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Function and pain related to knee
timeFrame: Change from pre-operative baseline at 2 and 4 months post-operative.
measure: Change in Mobility
timeFrame: Change from pre-operative baseline at 2 and 4 months post-operative.
Secondary outcomes:
measure: Change in Function and pain related to knee
timeFrame: Change from pre-operative baseline at 12 months post-operative.
measure: Change in Mobility
timeFrame: Change from pre-operative baseline at 12 months post-operative.
measure: Change in Walking
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
measure: Change in Lower extremity performance
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
measure: Change in Muscle strength
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
measure: Change in Knee range of motion
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
measure: Change in knee pain (VAS)
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
measure: Change in Disability
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
measure: Change in Pain
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
measure: Change in other symptoms such as swelling, restricted range of motion and mechanical symptoms
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
measure: Change in quality of life (QOL)
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
measure: Change in activities of daily living (ADL) Function
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
measure: Change in Sport and Recreation Function
timeFrame: pre-operative baseline and 2, 4 and 12 months post-operative
Other outcomes:
measure: Physical activity
timeFrame: Through study completion, an average of 1 year
measure: Satisfaction with the operated knee
timeFrame: 2, 4 and 12 months post-operative
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
city: Jyväskylä
country: Finland
facility: University of Jyväskylä
city: Turku
country: Finland
facility: Turku University Hospital
city: Turku
country: Finland
facility: Turku University of Applied Sciences
Study officials:
affiliation: Turku University Hospital
name: Keijo Mäkelä
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Jyvaskyla
name: Ari Heinonen
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.