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Knee OsteoarthritisBEE-RCTNCT03717727

Gamification in Knee Replacement Rehabilitation

A study testing Exergame in people with Knee Osteoarthritis, run by University of Jyvaskyla at 4 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Exergame
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
4 sitesFinland
Study dates
27 Nov 2018to 17 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Finland4 sites

  • Central Finland Central Hospital

    Jyväskylä

  • University of Jyväskylä

    Jyväskylä

  • Turku University Hospital

    Turku

  • Turku University of Applied Sciences

    Turku

Other trials in Finland

About this study

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

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.

Being tested
Exergame, Control
Keywords
Total knee replacement, Exergame, Total knee arthroplasty, Exercise, Physiotherapy, Physical functioning
Medical subject headings
Osteoarthritis, Knee, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExergameOther

    Also called Gamified rehabilitation

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

  • ControlOther

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

Study groups in NCT03717727
Study groupRoleWhat they receive
ExergameExperimentalHome-based exergame intervention and usual treatment.
Receives: Other: Exergame
ControlExperimentalHome-exercise by standard protocol and usual treatment.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Function and pain related to knee

    Oxford Knee Score

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

  2. Change in Mobility

    Timed Up and Go

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

Secondary outcomes (13)

  1. Change in Function and pain related to knee

    Oxford knee score

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

  2. Change in Mobility

    Timed Up and Go

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

  3. Change in Walking

    10-m Walking speed

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

  4. Change in Lower extremity performance

    Short Physical Performance Battery

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

  5. Change in Muscle strength

    Isometric knee extension and flexion strength

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

  6. Change in Knee range of motion

    Goniometer

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

  7. Change in knee pain (VAS)

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

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

  8. Change in Disability

    WHO disability scale (WHODAS 2.0.)

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

  9. Change in Pain

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

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

  10. Change in other symptoms such as swelling, restricted range of motion and mechanical symptoms

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

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

  11. Change in quality of life (QOL)

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

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

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

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

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

  13. Change in Sport and Recreation Function

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2018
  2. Study start27 Nov 2018
  3. Primary completion24 Mar 2021
  4. Study completion17 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03717727
Sponsor's protocol ID
T226/2018
Acronym
BEE-RCT
Status last verified
Jul 2023
First submitted
8 Oct 2018
Last updated
12 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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. Metadata published in the Jyväskylä University Digital Repository. Heinonen A, Janhunen M, Aarto-lahti E, et al. Metadata from: Gamification in Knee Replacement Rehabilitation (BEE-RCT). V.2.2.2023 doi:10.17011/jyx/dataset/85350

Publications

  • 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.

    PubMed 36441574

  • 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.

    PubMed 36896366

Questions about this trial

What is this clinical trial studying?

A study testing Exergame in people with Knee Osteoarthritis, run by University of Jyvaskyla at 4 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Function and pain related to knee (time frame: Change from pre-operative baseline at 2 and 4 months post-operative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03717727, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.

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