Shoulder Prosthesis Telerehab Care Trial

NCT ID: NCT05699031

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-09-30

Brief Summary

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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

Detailed Description

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Conditions

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SHOULDER ARTHROPLASTY REHABILITATION TELEREHABILITATION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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APP-GROUP

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

Group Type EXPERIMENTAL

APP

Intervention Type DEVICE

Patients allocated in the app-group will use the newly developed smartphone app te rehabilitate. 5 exercises are provided daily. Daily questionnaires will monitor exercise performance, VAS pain, household activities. Information modules will be sent at specific times.

PHYSIO-GROUP

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

Group Type ACTIVE_COMPARATOR

PHYSICAL THERAPY

Intervention Type OTHER

Patients allocated in the physio-group will go, twice a week, to a physical therapist of their choice to rehabilitate. The physical therapist will follow the general guidelines provided by the hospital (surgeon).

Interventions

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APP

Patients allocated in the app-group will use the newly developed smartphone app te rehabilitate. 5 exercises are provided daily. Daily questionnaires will monitor exercise performance, VAS pain, household activities. Information modules will be sent at specific times.

Intervention Type DEVICE

PHYSICAL THERAPY

Patients allocated in the physio-group will go, twice a week, to a physical therapist of their choice to rehabilitate. The physical therapist will follow the general guidelines provided by the hospital (surgeon).

Intervention Type OTHER

Other Intervention Names

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PHYSIO-GROUP

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Van Tongel, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent, University Hospital Ghent

Ann Cools, PhD

Role: STUDY_CHAIR

University Ghent

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Dominiek Vandenbosch, MSc

Role: CONTACT

+32 9 332 16 69

Facility Contacts

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Alexander Van Tongel, MD, PHD

Role: primary

Dominiek Vandenbosch, MSc

Role: backup

Other Identifiers

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ONZ-2022-0357

Identifier Type: -

Identifier Source: org_study_id

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