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Gamification in Knee Replacement Rehabilitation (BEE-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717727
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Turku University Hospital
Turku University of Applied Sciences
Jyväskylä Central Hospital
University of Oulu
Information provided by (Responsible Party):
University of Jyvaskyla

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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Exergame Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Gamification in Knee Replacement Rehabilitation. Randomized Controlled Trial and Qualitative Approach
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exergame
Home-based exergame intervention and usual treatment.
Other: Exergame
16-week home-based exercise intervention with exergaming system and usual treatment.
Other Name: Gamified rehabilitation

Experimental: Control
Home-exercise by standard protocol and usual treatment.
Other: Control
16-week home-based exercise by standard protocol and usual treatment.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Physical activity [ Time Frame: Through study completion, an average of 1 year ]
    Physical activity monitor

  2. Satisfaction with the operated knee [ Time Frame: 2, 4 and 12 months post-operative ]
    Questionnaire

  3. Life satisfaction [ Time Frame: pre-operative baseline and 2, 4 and 12 months post-operative ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717727


Contacts
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Contact: Keijo Mäkelä +358-40-1759933 keijo.makela@tyks.fi
Contact: Eeva Aartolahti +358-40-8053545 eeva.aartolahti@jyu.fi

Locations
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Finland
Central Finland Central Hospital Recruiting
Jyväskylä, Finland
Contact: Juha Paloneva, Prof.         
University of Jyväskylä Recruiting
Jyväskylä, Finland
Contact: Eeva Aartolahti, PhD         
Turku University Hospital Recruiting
Turku, Finland
Contact: Keijo Mäkelä, Adj. prof.         
Turku University of Applied Sciences Recruiting
Turku, Finland
Contact: Niina Katajapuu, MSc         
Sponsors and Collaborators
University of Jyvaskyla
Turku University Hospital
Turku University of Applied Sciences
Jyväskylä Central Hospital
University of Oulu
Investigators
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Principal Investigator: Keijo Mäkelä Turku University Hospital
Principal Investigator: Ari Heinonen University of Jyvaskyla

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Responsible Party: University of Jyvaskyla
ClinicalTrials.gov Identifier: NCT03717727    
Other Study ID Numbers: T226/2018
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Jyvaskyla:
Total knee replacement
Exergame
Total knee arthroplasty
Exercise
Physiotherapy
Physical functioning
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases