AzTrials
AzTrials

Arthroplasty, Replacement, KneeNCT04628468

Patient Reported Outcome Measures (PROMs) in Rehabilitation With or Without the Possible Use of a Mobile Application After Primary Knee or Hip Arthroplasty

A study testing moveUp and Predefined number of traditional physiotherapy sessions in people with Arthroplasty, Replacement, Knee and Rehabilitation, run by University Hospital, Ghent at 11 sites in Belgium.

Completed

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

Official record
Search all trials

Trial summary

Rehabilitation after primary knee or hip arthroplasty may include performing exercises with a physiotherapist. For patients who can work well with a computer, tablet or smartphone, it is now possible to use a mobile application (e.g. moveUp) to carry out a large part of the exercises more independently. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
moveUp and Predefined number of traditional physiotherapy sessions
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
416 participants
Where
11 sitesBelgium
Study dates
18 Jan 2021to 29 May 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Eligibility criteria:

  1. The patient is aged 18 years or older, has a Belgian National Number, is insured by a Belgian sickness fund, and is not staying in a nursing home or long term rehabilitation centre.
  2. The patient has sufficient knowledge of Dutch, French, German or English.
  3. The patient has a planned date between the next 1 to 8 weeks for a primary unilateral unicompartmental knee arthroplasty (UKA); a bicompartmental knee arthroplasty, (BKA), consisting of either two UKA or a UKA and a patellar replacement; or a total knee arthroplasty (TKA) or a total hip arthroplasty (THA).
  4. The patient is not planned to have a peri-operative procedure (e.g. intra-articular catheter) or postoperative procedure that is expected to significantly impact the rehabilitation in and out of hospital.
  5. In the 6 months after arthroplasty the patient is not planned to have surgery that may impact the arthroplasty rehabilitation.
  6. The patient is not suffering from a medical condition (e.g. Parkinson, multiple sclerosis, cerebrovascular accident) that is expected to significantly impact the rehabilitation or that constitutes a contra-indication for the use of the mobile application.
  7. The patient confirms to have easy and daily access to the internet, a mobile phone, a personal email address and a computer, tablet or smartphone, until 8 months after randomization.
  8. The patient does not upfront exclude the possibility whereby part of the rehabilitation is performed without a physical therapist physically being present.
  9. The patient is willing to complete online the patient reported outcomes and is aware that if he/she fails in this computer literacy test (performed before randomization) he/she will not be randomized and hence not included in the study. He/she will receive usual rehabilitation care.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Belgium11 sites

  • Antwerp University Hospital

    Antwerp

  • Centre Hospitalier Interrégional Edith Cavell (CHIREC), site Delta

    Auderghem

  • Centre Hospitalier Interrégional Edith Cavell (CHIREC), Hôpital de Braine L'Alleud-Waterloo

    Braine-l'Alleud

  • AZ Sint-Jan Brugge

    Bruges

  • AZ Monica Deurne

    Deurne

  • AZ Alma Eeklo

    Eeklo

  • AZ Maria Middelares

    Ghent

  • Universitair Ziekenhuis Gent

    Ghent

  • Jan Yperman Ziekenhuis

    Ieper

  • CHU de Liège, site du Sart Tilman

    Liège

  • AZ Damiaan

    Ostend

Other trials in Belgium

About this study

Official title: Patient Reported Outcome of Rehabilitation and Quality of Life in Computer Literate Patients Undergoing Primary Knee or Hip Arthroplasty and Randomized to Rehabilitation With or Without the Possible Use of a Mobile Application.

Rehabilitation after primary knee or hip arthroplasty may include performing exercises with a physiotherapist. For patients who can work well with a computer, tablet or smartphone, it is now possible to use a mobile application (e.g. moveUp) to carry out a large part of the exercises more independently. This is done with online guidance by a physiotherapist via a mobile application that is CE marked in Europe.

This study will investigate whether the effect of the mobile application on knee or hip rehabilitation and quality of life is equal to that of standard care (i.e. without the use of a mobile application).

Read the detailed description

Via the moveUP Coach App, patients receive personalized rehabilitation for knee or hip replacement, both before and after surgery. This mobile application is on the market, meets the legal requirements in Europe and has been provisionally remunerated under an agreement (convention) between the mandatory health insurance (NIHDI) and the hospital that participate in this study.

Eligible patients will be randomized to one of the three treatment options of the study:

  1. The "usual care group" will not be informed in detail about the mobile application and will receive usual rehabilitation care for knee- or hip replacement.
  2. The group "possibility to use the mobile application with a predefined number of physiotherapy sessions" will receive all necessary information on the mobile application and can still decide whether or not to receive rehabilitation with online guidance by a physiotherapist via the mobile application. A predefined number of traditional physiotherapy sessions is combined with the use of the mobile app in this group.
  3. The group "possibility to use the mobile application without a predetermined number of physiotherapy sessions" will receive all necessary information on the mobile application and can still decide whether or not to receive rehabilitation with online guidance by a physiotherapist via the mobile application. No predefined number of traditional physiotherapy sessions are required.

The patient will be asked to complete 2 questionnaires (KOOS-JR/HOOS-JR and EQ5D-5L) at baseline, 6 weeks and 6 months after arthroplasty. These patient reported outcomes will give an indication on the rehabilitation outcome and quality of life compared in the 3 groups.

At the end of the study, a health economic evaluation is foreseen by the Federal Knowledge Center for Healthcare (KCE). In this way the results can be helpful in getting a more definitive refund for the mobile application in Belgium.

Being tested
moveUp, Predefined number of traditional physiotherapy sessions
Keywords
mobile application, patient reported outcomes, PROMs, physiotherapy, telerehabilitation
Medical subject headings
Osteoarthritis, Hip

What participants receive

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

  • moveUpDevice

    Mobile application for use in the rehabilitation of primary knee and hip arthroplasty

  • Predefined number of traditional physiotherapy sessionsOther

    exercises with a physiotherapist being physically present

Study groups in NCT04628468
Study groupRoleWhat they receive
Possibility to use the mobile application without a predefined number of physiotherapy sessionsExperimentalRehabilitation after hip or knee arthroplasty with the option to use a mobile application and no predefined traditional physiotherapy.
Receives: Device: moveUp
Possibility to use the mobile application with a predefined number of physiotherapy sessionsExperimentalRehabilitation after hip or knee arthroplasty with the option to use a mobile application and a predefined number of traditional physiotherapy sessions
Receives: Device: moveUp; Other: Predefined number of traditional physiotherapy sessions
Usual careNo interventionRehabilitation after hip or knee arthroplasty without the use of a mobile application.

What is being measured

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

  1. Rehabilitation result 6 months after knee arthroplasty

    Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR score). KOOS-JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using a table provided. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.

    Measured: 6 months after arthroplasty

  2. Rehabilitation result 6 months after hip arthroplasty

    Hip dysfunction and Osteoarthritis Outcome score for Joint Replacement (HOOS-JR score). HOOS-JR is scored by summing the raw response (range 0-24) and then converting it to an interval score using a table provided. The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.

    Measured: 6 months after arthroplasty

Secondary outcomes (4)

  1. Rehabilitation result 6 weeks after knee arthroplasty

    Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR score). KOOS-JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using a table provided. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.

    Measured: 6 weeks after arthroplasty

  2. Rehabilitation result 6 weeks after hip arthroplasty

    Hip dysfunction and Osteoarthritis Outcome score for Joint Replacement (HOOS-JR score). HOOS-JR is scored by summing the raw response (range 0-24) and then converting it to an interval score using a table provided. The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.

    Measured: 6 weeks after arthroplasty

  3. Quality of life assessment 6 weeks after arthroplasty

    EQ5D-5L score. This score describes and values health-related quality of life and consist (1) the EQ-5D descriptive system with 5 dimensions each having 5 response levels from 1 indicating no problems to 5 indicating extreme problems, and (2) the EQ visual analogue scale (EQ VAS), a 0-100 scale with 0 score the worst health the patient can imagine and 100 the best health the patient can imagine.

    Measured: 6 weeks after arthroplasty

  4. Quality of life assessment 6 months after arthroplasty

    EQ5D-5L score. This score describes and values health-related quality of life and consist (1) the EQ-5D descriptive system with 5 dimensions each having 5 response levels from 1 indicating no problems to 5 indicating extreme problems, and (2) the EQ visual analogue scale (EQ VAS), a 0-100 scale with 0 score the worst health the patient can imagine and 100 the best health the patient can imagine.

    Measured: 6 months after arthroplasty

Timeline

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

  1. First posted13 Nov 2020
  2. Study start18 Jan 2021
  3. Primary completion29 May 2023
  4. Study completion29 May 2023

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
None (open label)
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04628468
Sponsor's protocol ID
KCE HTA C2020-1
Status last verified
Jul 2023
First submitted
27 Oct 2020
Last updated
7 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing moveUp and Predefined number of traditional physiotherapy sessions in people with Arthroplasty, Replacement, Knee and Rehabilitation, run by University Hospital, Ghent at 11 sites in Belgium.

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

Who may be eligible to take part?

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 7 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 11 sites in Belgium. 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?

Rehabilitation result 6 months after knee arthroplasty (time frame: 6 months after arthroplasty). 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 NCT04628468.

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 7 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in