Clinical trial NCT05699031: Shoulder Prosthesis Telerehab Care Trial
Official title: The PROTECT-study: Home-based Telerehabilitation in the Post-operative Care After Shoulder Arthroplasty Compared to Usual Care: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SHOULDER ARTHROPLASTY
REHABILITATION
TELEREHABILITATION
Keywords: SHOULDER ARTHROPLASTY
REHABILITATION
TELEREHABILITATION
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2023-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline pre-operative
timeFrame: Prior to surgery
measure: SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline post-operative
timeFrame: week 0
measure: SHOULDER PAIN AND DISABILITY INDEX (SPADI)
timeFrame: week 3
measure: SHOULDER PAIN AND DISABILITY INDEX (SPADI)
timeFrame: week 6
measure: SHOULDER PAIN AND DISABILITY INDEX (SPADI)
timeFrame: week 12
measure: SHOULDER PAIN AND DISABILITY INDEX (SPADI)
timeFrame: week 52
Secondary outcomes:
measure: ACTIVE MOBILITY (ROM) OF THE SHOULDER
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
measure: PASSIVE MOBILITY (ROM) OF THE SHOULDER
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
measure: STRENGTH
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
measure: CONSTANT-MURLEY SCORE
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
measure: ACTIVITIES OF DAILY LIVING EXTERNAL AND INTERNAL ROTATIONS (ADLEIR)
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
measure: SINGLE ASSESSMENT NUMERIC EVALUATION (SANE)
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
measure: EUROQOL 5-DIMENSIONS 5-LEVEL (EQ-5D-5L)
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
measure: GRONINGEN ACTIVITY RESTRICTION SCALE (GARS-4)
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
measure: EXERCISE ADHERENCE RATING SCALE (EARS)
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
measure: EXERCISE DIARY
timeFrame: Daily post-surgery (week 0 - week 12)
measure: SELF-EFFICACY FOR EXERCISES (SEE)
timeFrame: Week 3, week 6, week 12, week 52
measure: GLOBAL RATING OF CHANGE SCALE (GROC)
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
measure: GLOBAL PERCEIVED EFFECT (GPE/GEE)
timeFrame: Prior to surgery, week 3, week 6, week 12, week 52
Other outcomes:
measure: M-HEALTH APP USABILITY QUESTIONNAIRE (MAUQ)
timeFrame: Week 12
measure: SYSTEM USABILITY SCALE (SUS)
timeFrame: Week 12
measure: SINGLE EASE QUESTION (SEQ)
timeFrame: Week 12
measure: AGE
timeFrame: Pre-surgery
measure: GENDER
timeFrame: Pre-surgery
measure: DIAGNOSTICS
timeFrame: Pre-surgery
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Ghent, University Hospital Ghent
name: Alexander Van Tongel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Ann Cools, PhD
role: STUDY_CHAIR
References: