BEE-RCT: Gamification in Knee Replacement Rehabilitation

Sponsor
University of Jyvaskyla (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03717727
Collaborator
Turku University Hospital (Other), Turku University of Applied Sciences (Other), Jyväskylä Central Hospital (Other), University of Oulu (Other)
52
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2
37.1
13
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exergame
  • Other: Control
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
52 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 :
Nov 27, 2018
Actual Primary Completion Date :
Mar 24, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Function and pain related to knee [Change from pre-operative baseline at 2 and 4 months post-operative.]

      Oxford Knee Score

    2. Change in Mobility [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 [Change from pre-operative baseline at 12 months post-operative.]

      Oxford knee score

    2. Change in Mobility [Change from pre-operative baseline at 12 months post-operative.]

      Timed Up and Go

    3. Change in Walking [pre-operative baseline and 2, 4 and 12 months post-operative]

      10-m Walking speed

    4. Change in Lower extremity performance [pre-operative baseline and 2, 4 and 12 months post-operative]

      Short Physical Performance Battery

    5. Change in Muscle strength [pre-operative baseline and 2, 4 and 12 months post-operative]

      Isometric knee extension and flexion strength

    6. Change in Knee range of motion [pre-operative baseline and 2, 4 and 12 months post-operative]

      Goniometer

    7. Change in knee pain (VAS) [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 [pre-operative baseline and 2, 4 and 12 months post-operative]

      WHO disability scale (WHODAS 2.0.)

    9. Change in Pain [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 [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) [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 [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 [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 [Through study completion, an average of 1 year]

      Physical activity diary

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

      Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Central Finland Central Hospital Jyväskylä Finland
    2 University of Jyväskylä Jyväskylä Finland
    3 Turku University Hospital Turku Finland
    4 Turku University of Applied Sciences Turku Finland

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Keijo Mäkelä, Turku University Hospital
    • Principal Investigator: Ari Heinonen, University of Jyvaskyla

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Jyvaskyla
    ClinicalTrials.gov Identifier:
    NCT03717727
    Other Study ID Numbers:
    • T226/2018
    First Posted:
    Oct 24, 2018
    Last Update Posted:
    Dec 30, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Jyvaskyla
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 30, 2021