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Shoulder Prosthesis Telerehab Care Trial

ConditionsSHOULDER ARTHROPLASTYREHABILITATIONTELEREHABILITATION
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Hospital, Ghent

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

60 years and older

primary total shoulder arthroplasty (anatomical and reverse)

osteoarthritis, cuff tear arthropathy, pseudoparalysis

return home after discharge from hospital

Disqualifiers

revision arthroplasty

arthroplasty for fracture or tumor

neurological disease (parkinson, stroke, ...)

no access to smartphone, tablet or internet connectivity

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: APP-GROUPExperimental treatment 1 intervention
Group B: PHYSIO-GROUPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Prior to surgery
2

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

Time frame
week 0
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

Time frame
week 3
4

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

Time frame
week 6

Secondary outcomes

1

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 Score 2\) 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).

Time frame
Prior to surgery, week 3, week 6, week 12, week 52
2

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).

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

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

Time frame
Prior to surgery, week 3, week 6, week 12, week 52
4

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

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

Other outcomes

1

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.

Time frame
Week 12
2

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.

Time frame
Week 12
3

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.

Time frame
Week 12
4

AGE

Content: specify age of participant

Time frame
Pre-surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

University Ghent

Collaborator

Source ClinicalTrials.gov
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