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

NCT04628468 | Completed

• 1 other identifier: KCE HTA C2020-1
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 11

Brief 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. 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).

Conditions

Arthroplasty, Replacement, Knee; Rehabilitation; Hip Arthrosis

Keywords

mobile application; patient reported outcomes, PROMs; physiotherapy; telerehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months after arthroplasty

• 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.

  6 months after arthroplasty

Secondary Outcomes (4)

• Rehabilitation result 6 weeks after knee arthroplasty

  6 weeks after arthroplasty

• Rehabilitation result 6 weeks after hip arthroplasty

  6 weeks after arthroplasty

• Quality of life assessment 6 weeks after arthroplasty

  6 weeks after arthroplasty

• Quality of life assessment 6 months after arthroplasty

  6 months after arthroplasty

Other Outcomes (8)

• Incidents

  baseline until 6 months after arthroplasty

• Sensitivity endpoint KOOS-JR at 6 weeks

  baseline until 6 weeks after arthroplasty

• Sensitivity endpoint HOOS-JR at 6 weeks

  baseline until 6 weeks after arthroplasty

Study Arms (3)

Possibility to use the mobile application without a predefined number of physiotherapy sessions

EXPERIMENTAL

Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and no predefined traditional physiotherapy.

Device: moveUp

Possibility to use the mobile application with a predefined number of physiotherapy sessions

EXPERIMENTAL

Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and a predefined number of traditional physiotherapy sessions

Device: moveUp; Other: Predefined number of traditional physiotherapy sessions

Usual care

NO INTERVENTION

Rehabilitation after hip or knee arthroplasty without the use of a mobile application.

Interventions

moveUp DEVICE

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

Possibility to use the mobile application with a predefined number of physiotherapy sessions; Possibility to use the mobile application without a predefined number of physiotherapy sessions

Predefined number of traditional physiotherapy sessions OTHER

exercises with a physiotherapist being physically present

Possibility to use the mobile application with a predefined number of physiotherapy sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• National Institute for Health and Disability Insurance (NIHDI), Belgium: collaborator
• Belgium Health Care Knowledge Centre: collaborator

Study Sites (11)

Antwerp University Hospital

Antwerp, Belgium

Location

Centre Hospitalier Interrégional Edith Cavell (CHIREC), site Delta

Auderghem, Belgium

Location

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

Braine-l'Alleud, Belgium

Location

AZ Sint-Jan Brugge

Bruges, Belgium

Location

AZ Monica Deurne

Deurne, Belgium

Location

AZ Alma Eeklo

Eeklo, Belgium

Location

AZ Maria Middelares

Ghent, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Jan Yperman Ziekenhuis

Ieper, Belgium

Location

CHU de Liège, site du Sart Tilman

Liège, Belgium

Location

AZ Damiaan

Ostend, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Catherine Van Der Straeten, Professor

  Health, Innovation and Research Institute UZ Ghent

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 13, 2020
• Study Start: January 18, 2021
• Primary Completion: May 29, 2023
• Study Completion: May 29, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (11)