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Completed

NCT Number: NCT03717727

Gamification in Knee Replacement Rehabilitation

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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Finland Central Hospital, Jyväskylä, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exergame

Other

16-week home-based exercise intervention with exergaming system and usual treatment.

Other names: Gamified rehabilitation

Control

Other

16-week home-based exercise by standard protocol and usual treatment.

Primary outcomes

  1. Change in Function and pain related to knee

    Time frame: Change from pre-operative baseline at 2 and 4 months post-operative.

    Oxford Knee Score

  2. Change in Mobility

    Time frame: Change from pre-operative baseline at 2 and 4 months post-operative.

    Timed Up and Go

Secondary outcomes

  1. Change in Function and pain related to knee

    Time frame: Change from pre-operative baseline at 12 months post-operative.

    Oxford knee score

  2. Change in Mobility

    Time frame: Change from pre-operative baseline at 12 months post-operative.

    Timed Up and Go

  3. Change in Walking

    Time frame: pre-operative baseline and 2, 4 and 12 months post-operative

    10-m Walking speed

  4. Change in Lower extremity performance

    Time frame: pre-operative baseline and 2, 4 and 12 months post-operative

    Short Physical Performance Battery

  5. Change in Muscle strength

    Time frame: pre-operative baseline and 2, 4 and 12 months post-operative

    Isometric knee extension and flexion strength

  6. Change in Knee range of motion

    Time frame: pre-operative baseline and 2, 4 and 12 months post-operative

    Goniometer

  7. Change in knee pain (VAS)

    Time frame: pre-operative baseline and 2, 4 and 12 months post-operative

    Visual analogue scale (0 to 100 mm), Constant score (0 to 100 points)

  8. Change in Disability

    Time frame: pre-operative baseline and 2, 4 and 12 months post-operative

    WHO disability scale (WHODAS 2.0.)

  9. Change in Pain

    Time frame: pre-operative baseline and 2, 4 and 12 months post-operative

    Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on pain.

  10. 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

    Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on symptoms

  11. Change in quality of life (QOL)

    Time frame: pre-operative baseline and 2, 4 and 12 months post-operative

    Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on QOL

  12. Change in activities of daily living (ADL) Function

    Time frame: pre-operative baseline and 2, 4 and 12 months post-operative

    Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on ADL

  13. Change in Sport and Recreation Function

    Time frame: pre-operative baseline and 2, 4 and 12 months post-operative

    Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on Sport and Recreation Function

Other outcomes

  1. Physical activity

    Time frame: Through study completion, an average of 1 year

    Physical activity diary

  2. Satisfaction with the operated knee

    Time frame: 2, 4 and 12 months post-operative

    Questionnaire

Sponsors and collaborators

Lead sponsor

University of Jyvaskyla

Other

Collaborators

  • Jyväskylä Central Hospital
  • Turku University Hospital
  • Turku University of Applied Sciences
  • University of Oulu

Registry information

Official study title

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

Acronym: BEE-RCT

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Oct 24, 2018
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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