Actively Recruiting
Home-based Telerehabilitation After Shoulder Arthroplasty Compared to Usual Physical Therapy Care: The PROTECT Randomized Control Trial
Led by University Hospital, Ghent · Updated on 2024-04-12
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
U
University Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a smartphone app for home-based telerehabilitation compared to usual physical therapy care after primary shoulder arthroplasty in patients aged 60 years and older. The study aims to see if rehabilitation outcomes with the app are as good as with standard care, to compare outcomes between anatomical and reverse shoulder arthroplasty, and to assess the usability of the app. Participants are randomly assigned to one of two groups. The app group will use a smartphone app delivering five daily exercises, daily questionnaires on exercise performance, pain, and activities, and receive information modules at specific times. The physical therapy group will have twice-weekly sessions with a physical therapist following hospital guidelines. Rehabilitation and assessments occur from surgery up to 3 months, with follow-up at 1 year. During the study, participants complete questionnaires at specific times between surgery and one year post-operation. Outcome measures include the Shoulder Pain and Disability Index (SPADI) assessed before surgery, at weeks 0, 3, 6, 12, and at 52 weeks, along with secondary measures like shoulder mobility, strength, daily living activities, exercise adherence, and quality of life. Exercise diaries and questionnaires track progress and adherence. The total study duration for participants extends to one year post-surgery.
CONDITIONS
Brief Title
Shoulder Prosthesis Telerehab Care Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Underwent primary total shoulder arthroplasty (anatomical or reverse)
- Diagnosed with osteoarthritis, cuff tear arthropathy, or pseudoparalysis
- Returning home after hospital discharge
- No brace used after surgery
- Able to understand and communicate in written and spoken language
- Have hospitalization insurance
You will not qualify if you...
- Undergoing revision arthroplasty
- Arthroplasty performed for fracture or tumor
- Having neurological diseases such as Parkinson's disease or stroke
- No access to a smartphone, tablet, or internet connection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge
Participants undergo shoulder arthroplasty surgery followed by immediate recovery and hospital discharge.
Hospital stay and discharge visit
Duration - 12 weeks
Participants receive rehabilitation through either a smartphone app with daily exercises and questionnaires, or twice-weekly physical therapy sessions following usual care protocols.
Daily use of app or twice-weekly physical therapy visits for up to 12 weeks
Duration - Up to 52 weeks
Participants are assessed for shoulder function, pain, and quality of life at multiple time points after treatment to monitor recovery and long-term outcomes.
Assessments at weeks 3, 6, 12, and 52
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
D
Dominiek Vandenbosch, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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