NCT03717727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 27, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2022

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

October 8, 2018

Last Update Submit

July 10, 2023

Conditions

Knee Osteoarthritis

Keywords

Total knee replacementExergameTotal knee arthroplastyExercisePhysiotherapyPhysical functioning

Outcome Measures

Primary Outcomes (2)

  • Change in Function and pain related to knee

    Oxford Knee Score

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

  • Change in Mobility

    Timed Up and Go

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

Secondary Outcomes (13)

  • Change in Function and pain related to knee

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

  • Change in Mobility

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

  • Change in Walking

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

  • Change in Lower extremity performance

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

  • Change in Muscle strength

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

  • +8 more secondary outcomes

Other Outcomes (2)

  • Physical activity

    Through study completion, an average of 1 year

  • Satisfaction with the operated knee

    2, 4 and 12 months post-operative

Study Arms (2)

Exergame

EXPERIMENTAL

Home-based exergame intervention and usual treatment.

Other: Exergame

Control

EXPERIMENTAL

Home-exercise by standard protocol and usual treatment.

Other: Control

Interventions

ExergameOTHER

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

Also known as: Gamified rehabilitation
Exergame
ControlOTHER

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

Control

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Central Finland Central Hospital

Jyväskylä, Finland

Location

University of Jyväskylä

Jyväskylä, Finland

Location

Turku University Hospital

Turku, Finland

Location

Turku University of Applied Sciences

Turku, Finland

Location

Related Publications (2)

  • 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.

    PMID: 36441574BACKGROUND

  • 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.

    PMID: 36896366RESULT

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Keijo Mäkelä

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

  • Ari Heinonen

    University of Jyvaskyla

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 24, 2018

Study Start

November 27, 2018

Primary Completion

March 24, 2021

Study Completion

January 17, 2022

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

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

Available IPD Datasets

Metadata Access

Locations

FI(4)