Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05699031
Other study ID # ONZ-2022-0357
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date September 30, 2026

Study information

Verified date April 2024
Source University Hospital, Ghent
Contact Dominiek Vandenbosch, MSc
Phone +32 9 332 16 69
Email dominiek.vandenbosch@ugent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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).

Locations

Country Name City State
Belgium Ghent University Hospital Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Ghent University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Other AGE Content: specify age of participant Pre-surgery
Other GENDER Content: specify gender of participant Pre-surgery
Other DIAGNOSTICS Content: specify why patient needed a shoulder arthroplasty Pre-surgery
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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).
Prior to surgery, week 3, week 6, week 12, week 52
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04458480 - Effect of Fast Inpatient Rehabilitation After TKA
Recruiting NCT06238596 - Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study) N/A
Recruiting NCT05547152 - Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03661944 - Functional Performance Assessments in Overhead Athletes With Shoulder Injury
Completed NCT05875480 - The Effectiveness of Telerehabilitation After Arthroscopic Meniscus Repair N/A
Not yet recruiting NCT05854056 - Tibial Tubercle Distalisation and Accelerated Rehabilitation N/A
Not yet recruiting NCT05177380 - Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis N/A
Not yet recruiting NCT04419753 - The Role of Attention Focus Walking Training in Older Adults. N/A
Not yet recruiting NCT03628495 - Effectiveness of a Combined Pressure and Silicone Intervention for Hypertrophic Scar Treatment N/A
Completed NCT02413996 - Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty N/A
Completed NCT01205542 - Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function N/A
Completed NCT02644096 - Rehabilitation of Patients After THR - Based on Patients´Selfrated Health Phase 1
Completed NCT03582371 - Aqua Stand-Up Paddle Balance Effect in Parkinson's Disease (AquaSUP PARK) N/A
Completed NCT05655039 - The Effect of Pre-rehabilitation and Rehabilitation Period on Functional Status in Inpatient Stroke Patients
Completed NCT04502654 - Rehabilitation for Thoracoscopic Lobectomy
Completed NCT06206018 - Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Health Care N/A
Completed NCT03386604 - Physical Capacity of Patients With Chronic Obstructive Pulmonary Disease With and Without Supplementation of Whey N/A
Recruiting NCT05619666 - Acute Rehabilitation in Patients With COVID-19 Pneumonia N/A
Completed NCT06251791 - Inspiratory Muscle Training and Expiratory Muscle Thickness N/A