Shoulder Prosthesis Telerehab Care Trial (PROTECT)

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

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

Study Overview

• Status: Recruiting
• Conditions: SHOULDER ARTHROPLASTY; REHABILITATION; TELEREHABILITATION
• Intervention / Treatment: Device: APP; Other: PHYSICAL THERAPY

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominiek Vandenbosch, MSc; Phone Number: +32 9 332 16 69; Email: dominiek.vandenbosch@ugent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Alexander Van Tongel, MD, PHD
    • Contact: Dominiek Vandenbosch, MSc; Email: dominiek.vandenbosch@ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APP-GROUP; Patients allocated in the app-group will use the app to rehabilitate.	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.
Active Comparator: PHYSIO-GROUP; Patients allocated in the physio-group will rehabilitate according to the usual care protocol	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).; Other Names: PHYSIO-GROUP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline pre-operative	Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder	Prior to surgery
SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline post-operative	Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder	week 0
SHOULDER PAIN AND DISABILITY INDEX (SPADI)	Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder	week 3
SHOULDER PAIN AND DISABILITY INDEX (SPADI)	Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder	week 6
SHOULDER PAIN AND DISABILITY INDEX (SPADI)	Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder	week 12
SHOULDER PAIN AND DISABILITY INDEX (SPADI)	Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder	week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACTIVE MOBILITY (ROM) OF THE SHOULDER	ACTIVE ROM: forward flexion and abduction with extended elbow, functional internal and external rotation in standing position.; maximal pain free ROM; forward flexion and abduction with extended elbow: measured with the EasyAngle (Meloq AB Sweden); hand-to-back and hand-nek test : scored as in Constant-Murley Score2) PASSIVE: forward flexion, abduction, external and internal rotation in supine position.; maximal pain free ROM; forward flexion and abduction: measured with the EasyAngle (Meloq AB Sweden); rotations: measured as ER1 (arm at the side)/ ER2 (arm in 90° abduction) and IR1 (arm in 90° forward flexion)/ IR2 (arm in 90° abduction) with the EasyAngle (Meloq AB Sweden).	Prior to surgery, week 3, week 6, week 12, week 52
PASSIVE MOBILITY (ROM) OF THE SHOULDER	PASSIVE: forward flexion, abduction, external and internal rotation in supine position.; maximal pain free ROM; forward flexion and abduction: measured with the EasyAngle (Meloq AB Sweden); rotations: measured as ER1 (arm at the side)/ ER2 (arm in 90° abduction) and IR1 (arm in 90° forward flexion)/ IR2 (arm in 90° abduction) with the EasyAngle (Meloq AB Sweden).	Prior to surgery, week 3, week 6, week 12, week 52
STRENGTH	Forward flexion, extension, ab- and adduction, external and internal rotation.; isometrical contraction for 5 seconds, 3 repetitions, 30 sec break in between; measured with EasyForce (Meloq AB Sweden); seated, both feet on the ground, back against backrest; elbow flexed (90°) held at side, fist forward, thumb upward	Prior to surgery, week 3, week 6, week 12, week 52
CONSTANT-MURLEY SCORE	Content: partially clinical (65 points) and partially PROM (35 points) assessed. Scoring: The formula to calculate the total score is:" pain (0-15) + ADL (4x (0-5) = 0-20) + mobility (4 x (0-10) = 0-40) + strength (0 -25)". Strength will be measured with the arm elevated to 90 ° in the scapular plane using an IDOmeter. Interpretation: 0-55 points = bad, 56-70 points = mediocre, 71-85 points = good, 86-100 points = excellent score	Prior to surgery, week 3, week 6, week 12, week 52
ACTIVITIES OF DAILY LIVING EXTERNAL AND INTERNAL ROTATIONS (ADLEIR)	Content: 12 questions about specific ADL tasks that require external or internal rotation while performing. Scoring: Each activity is scored between 0 (unable to do) and 3 (not difficult at all). All activities should be performed without the help of flexing the neck or bending the trunk and without the help of first abducting the elbow (i.e., without doing a hornblower sign). Interpretation: The maximal score is 36. A higher score means that the patient is able to perform ADL activities with enough strength in external and internal rotation	Prior to surgery, week 3, week 6, week 12, week 52
SINGLE ASSESSMENT NUMERIC EVALUATION (SANE)	Content: 1 question: 'how would you rate your shoulder today as a percentage of normal?'. Scoring: percentage between 0 and 100% Interpretation: 100% being a normal shoulder.	Prior to surgery, week 3, week 6, week 12, week 52
EUROQOL 5-DIMENSIONS 5-LEVEL (EQ-5D-5L)	Content: 5 questions + EQ-5D VAS for general health. Scoring: 5-response scale (from 'no problems' to 'extreme problems') + VAS percentage between 0 (worst imaginable health state) and 100 (best imaginable health state). Interpretation: VAS score for general health indicates how a patient perceives his general health, Other questions are descriptive for problems in mobility, self-care, usual activities, pain/ discomfort, anxiety/depression.	Prior to surgery, week 3, week 6, week 12, week 52
GRONINGEN ACTIVITY RESTRICTION SCALE (GARS-4)	Content: 18 questions to identify problems with self-sufficiency in self-care and housekeeping. Patients do not respond if they do that activity but rather if they could do that activity. Scoring: ordinal scale from 1 (Yes, I can do that on my own without any effort) up to 4 (No, I can't do that on my own, but only with the help of others). Interpretation: A higher score (max 72) is related to a lower self-sufficiency.	Prior to surgery, week 3, week 6, week 12, week 52
EXERCISE ADHERENCE RATING SCALE (EARS)	Content: 3 sections section A: 6 questions to evaluate the prescribed exercises. section B: 6 questions on how a patient does the recommended exercises or activities. section C: 10 statements on why a patient does or does not do the recommended exercises or activities. Scoring: sections B and C: 5-point Likert scale (0 - 4) (some questions scored reversed). Interpretation: section B (range 0 - 24): a higher score indicates a better compliance/adherence . section C (range 0 - 40): a higher score indicates a better adherence.	Prior to surgery, week 3, week 6, week 12, week 52
EXERCISE DIARY	Content: performed exercises, household activities, VAS pain. Diary on paper for physio-group, by the app for the app-group.	Daily post-surgery (week 0 - week 12)
SELF-EFFICACY FOR EXERCISES (SEE)	Content: 9 questions about 'confidence in engaging in exercise 3 times a week for 20 minutes if faced with a barrier'. Scoring: 'not very confident' (0) and 'very confident' (10). Interpretation: The higher the score , the patient feel more confident in performing prescribed exercises.	Week 3, week 6, week 12, week 52
GLOBAL RATING OF CHANGE SCALE (GROC)	Content: A single question (How would you currently describe the change in your operated shoulder compared to just before surgery) is scored on a scale, ranging from 'very much worse' through 'unchanged' to 'completely recovered'. Scoring: The scale used is divided in 11 points ( very much worse -5, the same 0, very much better + 5) Interpretation: the number given indicates how a patient perceives the change after surgery.	Prior to surgery, week 3, week 6, week 12, week 52
GLOBAL PERCEIVED EFFECT (GPE/GEE)	Content: 2 questions: To what extent have you recovered from your symptoms?, How satisfied are you with your treatment?. Scoring: a 7-point rating scale. Interpretation: The higher the score , the better.	Prior to surgery, week 3, week 6, week 12, week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
M-HEALTH APP USABILITY QUESTIONNAIRE (MAUQ)	Content: 21 questions in 3 categories: ease of use and satisfaction, system information arrangement, usefulness (version for interactive app, user patient and provider). Scoring: between 1 (strongly disagree) and 7 (strongly agree) => average score. Interpretation: the higher the score the higher the usability.	Week 12
SYSTEM USABILITY SCALE (SUS)	Content: 10 questions about system satisfaction, usability and learnability. Scoring: 5 response options ranging from strongly disagree (1) to strongly agree (5). Interpretation: A score above 68 (/100) is considered above average, while a score lower than 68 is considered a below average score.	Week 12
SINGLE EASE QUESTION (SEQ)	Content: 1 question to assess how difficult users find a task. Scoring: 7-point rating scale ranging from very difficult (1) to very easy (7). Interpretation: The average SEQ score is 5.5 (between 5.3 and 5.6). It is advised to ask a more detailed information/ explanation if a score <5 is given.	Week 12
AGE	Content: specify age of participant	Pre-surgery
GENDER	Content: specify gender of participant	Pre-surgery
DIAGNOSTICS	Content: specify why patient needed a shoulder arthroplasty	Pre-surgery

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent
• Investigators: Principal Investigator: Alexander Van Tongel, PhD, University Ghent, University Hospital Ghent; Study Chair: Ann Cools, PhD, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: SHOULDER ARTHROPLASTY; REHABILITATION; TELEREHABILITATION
• Other Study ID Numbers: ONZ-2022-0357

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No