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NCT Number: NCT05699031

Shoulder Prosthesis Telerehab Care 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

Recruiting

Interested in participating?

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Alexander Van Tongel, MD, PHD

CONTACT

Dominiek Vandenbosch, MSc

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App

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.

Physical Therapy

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).

Other names: PHYSIO-GROUP

Primary outcomes

  1. SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline pre-operative

    Time frame: Prior to surgery

    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

  2. SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline post-operative

    Time frame: week 0

    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

  3. SHOULDER PAIN AND DISABILITY INDEX (SPADI)

    Time frame: week 3

    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

  4. SHOULDER PAIN AND DISABILITY INDEX (SPADI)

    Time frame: week 6

    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

  5. SHOULDER PAIN AND DISABILITY INDEX (SPADI)

    Time frame: week 12

    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

  6. SHOULDER PAIN AND DISABILITY INDEX (SPADI)

    Time frame: week 52

    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

Secondary outcomes

  1. ACTIVE MOBILITY (ROM) OF THE SHOULDER

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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 Score
    • 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).
  2. PASSIVE MOBILITY (ROM) OF THE SHOULDER

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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).
  3. STRENGTH

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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
  4. CONSTANT-MURLEY SCORE

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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

  5. ACTIVITIES OF DAILY LIVING EXTERNAL AND INTERNAL ROTATIONS (ADLEIR)

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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

  6. SINGLE ASSESSMENT NUMERIC EVALUATION (SANE)

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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.

  7. EUROQOL 5-DIMENSIONS 5-LEVEL (EQ-5D-5L)

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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.

  8. GRONINGEN ACTIVITY RESTRICTION SCALE (GARS-4)

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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.

  9. EXERCISE ADHERENCE RATING SCALE (EARS)

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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.

  10. EXERCISE DIARY

    Time frame: Daily post-surgery (week 0 - week 12)

    Content: performed exercises, household activities, VAS pain. Diary on paper for physio-group, by the app for the app-group.

  11. SELF-EFFICACY FOR EXERCISES (SEE)

    Time frame: Week 3, week 6, week 12, week 52

    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.

  12. GLOBAL RATING OF CHANGE SCALE (GROC)

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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.

  13. GLOBAL PERCEIVED EFFECT (GPE/GEE)

    Time frame: Prior to surgery, week 3, week 6, week 12, week 52

    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.

Other outcomes

  1. M-HEALTH APP USABILITY QUESTIONNAIRE (MAUQ)

    Time frame: Week 12

    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.

  2. SYSTEM USABILITY SCALE (SUS)

    Time frame: Week 12

    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.

  3. SINGLE EASE QUESTION (SEQ)

    Time frame: Week 12

    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.

  4. AGE

    Time frame: Pre-surgery

    Content: specify age of participant

  5. GENDER

    Time frame: Pre-surgery

    Content: specify gender of participant

  6. DIAGNOSTICS

    Time frame: Pre-surgery

    Content: specify why patient needed a shoulder arthroplasty

Study contacts

Contact information is provided by the study sponsor or research team.

Dominiek Vandenbosch, MSc

CONTACT

[email protected]

+32 9 332 16 69

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Acronym: PROTECT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2023
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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