SHOULDER ARTHROPLASTYPROTECTNCT05699031
Shoulder Prosthesis Telerehab Care Trial
A study testing APP and PHYSICAL THERAPY in people with SHOULDER ARTHROPLASTY and REHABILITATION, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- SHOULDER ARTHROPLASTY, REHABILITATION, TELEREHABILITATION
- What is being tested?
- APP and PHYSICAL THERAPY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- revision arthroplasty
- arthroplasty for fracture or tumor
- neurological disease (parkinson, stroke, ...)
- no access to smartphone, tablet or internet connectivity
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Alexander Van Tongel, MD, PHD
Dominiek Vandenbosch, MSc, dominiek.vandenbosch@ugent.be
About this study
Official title: 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
- Conditions
- SHOULDER ARTHROPLASTY, REHABILITATION, TELEREHABILITATION
- Being tested
- APP, PHYSICAL THERAPY
- Keywords
- SHOULDER ARTHROPLASTY, REHABILITATION, TELEREHABILITATION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPDevice
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 THERAPYOther
Also called PHYSIO-GROUP
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).
| Study group | Role | What they receive |
|---|---|---|
| APP-GROUP | Experimental | Patients allocated in the app-group will use the app to rehabilitate. Receives: Device: APP |
| PHYSIO-GROUP | Active comparator | Patients allocated in the physio-group will rehabilitate according to the usual care protocol Receives: Other: PHYSICAL THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: week 52
Secondary outcomes (13)
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
- 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Prior to surgery, week 3, week 6, week 12, week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Mar 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SHOULDER ARTHROPLASTYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Alexander Van Tongel, PhD, Principal investigator, University Ghent, University Hospital GhentAnn Cools, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699031
- Sponsor's protocol ID
- ONZ-2022-0357
- Acronym
- PROTECT
- Status last verified
- Apr 2024
- First submitted
- 23 Dec 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PROTECT-study: Home-based Telerehabilitation in the Post-operative Care After Shoulder Arthroplasty Compared to Usual Care: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05699031
- Acronym / sponsor ID
- PROTECT / ONZ-2022-0357
- Conditions
- SHOULDER ARTHROPLASTY, REHABILITATION, TELEREHABILITATION
- Keywords
- SHOULDER ARTHROPLASTY, REHABILITATION, TELEREHABILITATION
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APP-GROUP | Experimental | Device: APPPatients allocated in the app-group will use the app to rehabilitate. |
| PHYSIO-GROUP | Active comparator | Other: PHYSICAL THERAPYPatients allocated in the physio-group will rehabilitate according to the usual care protocol |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- revision arthroplasty
- arthroplasty for fracture or tumor
- neurological disease (parkinson, stroke, ...)
- no access to smartphone, tablet or internet connectivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APPPatients 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. | Device | APP-GROUP |
| PHYSICAL THERAPYAlso: PHYSIO-GROUPPatients 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 | PHYSIO-GROUP |
Primary outcome
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
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
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
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
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
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
13 secondary outcomes
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
GLOBAL PERCEIVED EFFECT (GPE/GEE)
Time frame: Prior to surgery, week 3, week 6, week 12, week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Van Tongel, PhD principal investigator
University Ghent, University Hospital Ghent
Ann Cools, PhD study chair
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APP and PHYSICAL THERAPY in people with SHOULDER ARTHROPLASTY and REHABILITATION, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominiek Vandenbosch, MSc (+32 9 332 16 69, dominiek.vandenbosch@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline pre-operative (time frame: Prior to surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.