Ghent University Hospital
Ghent, 9000, Belgium
Location status: Recruiting
NCT Number: NCT05699031
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
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Ghent, 9000, Belgium
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
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
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
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
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
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
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.
Time frame: Prior to surgery, week 3, week 6, week 12, week 52
PASSIVE: forward flexion, abduction, external and internal rotation in supine position.
Time frame: Prior to surgery, week 3, week 6, week 12, week 52
Forward flexion, extension, ab- and adduction, external and internal rotation.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Pre-surgery
Content: specify age of participant
Time frame: Pre-surgery
Content: specify gender of participant
Time frame: Pre-surgery
Content: specify why patient needed a shoulder arthroplasty
Contact information is provided by the study sponsor or research team.
University Hospital, Ghent
Other
The PROTECT-study: Home-based Telerehabilitation in the Post-operative Care After Shoulder Arthroplasty Compared to Usual Care: a Randomized Control Trial
Acronym: PROTECT
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.
Published trials that share one or more normalized conditions with this study.
NCT07282561
Malnutrition Elderly, Rehabilitation
Rome, Italy
View Trial DetailsNCT06869343
Arm Injuries, Fractures, Bone
Charlottesville, Virginia, United States
View Trial DetailsNCT06902714
Shoulder Arthroplasty
Birmingham, Alabama, United States
View Trial DetailsNCT03511586
Shoulder Arthroplasty
Phoenix, Arizona, United States
View Trial Details