Shoulder Prosthesis Telerehab Care Trial (PROTECT)

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: REHABILITATION; SHOULDER ARTHROPLASTY; TELEREHABILITATION

Treatments: Other: PHYSICAL THERAPY; Device: APP

Study type: Interventional

Funder types: Other

Identifiers

NCT05699031

ONZ-2022-0357

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

APP-GROUP

Experimental group

Description:

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

Treatment:

Device: APP

PHYSIO-GROUP

Active Comparator group

Description:

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

Treatment:

Other: PHYSICAL THERAPY