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NCT05699031 | Recruiting | SHOULDER ARTHROPLASTY


Shoulder Prosthesis Telerehab Care Trial
Sponsor:

University Hospital, Ghent

Brief Summary:

The goal of this clinical trial is to compare the rehabilitation by use of a smartphone-app with the usual care of physical therapy in patients, 60 years and older, who underwent a primary shoulder arthroplasty. The main questions it aims to answer are: is the outcome of rehabilitation with the app as good as the usual care? is the outcome for both types of shoulder arthroplasty similar? what is the usability of the app?. Participants will have treatment according to the group they are allocated to fill in questionnaires at specific moments during the rehabilitation stage (0 - 3 months ) and at 1 year post-surgery

Condition or disease

SHOULDER ARTHROPLASTY

REHABILITATION

TELEREHABILITATION

Intervention/treatment

APP

PHYSICAL THERAPY

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 120 participants
Masking : Single
Primary Purpose : Treatment
Official Title : The PROTECT-study: Home-based Telerehabilitation in the Post-operative Care After Shoulder Arthroplasty Compared to Usual Care: a Randomized Control Trial
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : September 30, 2026
Arm Intervention/treatment

Experimental: APP-GROUP

Patients allocated in the app-group will use the app to rehabilitate.

Device: APP

Active Comparator: PHYSIO-GROUP

Patients allocated in the physio-group will rehabilitate according to the usual care protocol

Other: PHYSICAL THERAPY

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 60 years and older
  • primary total shoulder arthroplasty (anatomical and reverse)
  • osteoarthritis, cuff tear arthropathy, pseudoparalysis
  • return home after discharge from hospital
  • no brace after surgery
  • sufficient verbal and written comprehension
  • hospitalization insurance
Exclusion Criteria
  • revision arthroplasty
  • arthroplasty for fracture or tumor
  • neurological disease (parkinson, stroke, ...)
  • no access to smartphone, tablet or internet connectivity

Shoulder Prosthesis Telerehab Care Trial

Location Details


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Shoulder Prosthesis Telerehab Care Trial

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Belgium,

Ghent University Hospital

Ghent, Belgium, 9000

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