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Recruiting NCT05699031

Shoulder Prosthesis Telerehab Care Trial

No phase Interventional SHOULDER ARTHROPLASTY REHABILITATION TELEREHABILITATION

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APP, PHYSICAL THERAPY.
Who it may be relevant to
Registry conditions: SHOULDER ARTHROPLASTY, REHABILITATION, TELEREHABILITATION. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The PROTECT-study: Home-based Telerehabilitation in the Post-operative Care After Shoulder Arthroplasty Compared to Usual Care: a Randomized Control Trial

Overview

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

Interventions

  • Device 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.
  • Other 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).

Primary outcome measures

  • SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline pre-operative [Time frame: Prior to surgery]
  • SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline post-operative [Time frame: week 0]
  • SHOULDER PAIN AND DISABILITY INDEX (SPADI) [Time frame: week 3]
  • SHOULDER PAIN AND DISABILITY INDEX (SPADI) [Time frame: week 6]
  • SHOULDER PAIN AND DISABILITY INDEX (SPADI) [Time frame: week 12]
  • SHOULDER PAIN AND DISABILITY INDEX (SPADI) [Time frame: week 52]
Secondary outcome measures (12)
  • ACTIVE MOBILITY (ROM) OF THE SHOULDER [Time frame: Prior to surgery, week 3, week 6, week 12, week 52]
  • PASSIVE MOBILITY (ROM) OF THE SHOULDER [Time frame: Prior to surgery, week 3, week 6, week 12, week 52]
  • STRENGTH [Time frame: Prior to surgery, week 3, week 6, week 12, week 52]
  • CONSTANT-MURLEY SCORE [Time frame: Prior to surgery, week 3, week 6, week 12, week 52]
  • ACTIVITIES OF DAILY LIVING EXTERNAL AND INTERNAL ROTATIONS (ADLEIR) [Time frame: Prior to surgery, week 3, week 6, week 12, week 52]
  • SINGLE ASSESSMENT NUMERIC EVALUATION (SANE) [Time frame: Prior to surgery, week 3, week 6, week 12, week 52]
  • EUROQOL 5-DIMENSIONS 5-LEVEL (EQ-5D-5L) [Time frame: Prior to surgery, week 3, week 6, week 12, week 52]
  • GRONINGEN ACTIVITY RESTRICTION SCALE (GARS-4) [Time frame: Prior to surgery, week 3, week 6, week 12, week 52]
  • EXERCISE ADHERENCE RATING SCALE (EARS) [Time frame: Prior to surgery, week 3, week 6, week 12, week 52]
  • EXERCISE DIARY [Time frame: Daily post-surgery (week 0 - week 12)]
  • SELF-EFFICACY FOR EXERCISES (SEE) [Time frame: Week 3, week 6, week 12, week 52]
  • GLOBAL RATING OF CHANGE SCALE (GROC) [Time frame: Prior to surgery, week 3, week 6, week 12, week 52]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Ghent University Hospital — Ghent

Identifiers

NCT: NCT05699031 · ONZ-2022-0357

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗