Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair (NCT03648047) | Clinical Trial Compass
TerminatedNot Applicable
Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair
Stopped: COVID-19 pandemic imposed restrictions to normal study conduct
Portugal50 participantsStarted 2018-11-11
Plain-language summary
This study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital kinematic biofeedback system against conventional in-person home-based rehabilitation, with the intent of reducing the need for face-to-face sessions.
The investigators hypothesize that the clinical outcomes of such a program will be at least similar to those of conventional rehabilitation.
Patients will be enrolled pre-operatively and then randomized into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform a 12 to 16-week rehabilitation program starting immediately after surgery.
Outcomes will be measured at baseline, 8 and 12 weeks. In patients where a decision is made to extend the program to 16 weeks, another assessment will be made at this point.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Shoulder pain and functional limitation with clinical examination compatible with rotator cuff tendinopathy
* Imaging (MRI or ultrasound) evidence of rotator cuff tear (supra and/or infraspinatus tendon tear inferior to 3 cm? or 5cm?)
* Indication for a simple rotator cuff repair according to the patient´s orthopedic surgeon
* Ability to understand simple and complex motor commands
* Availability of a carer to assist the patient after surgery
Exclusion Criteria:
* Patients admitted for revision cuff repair
* Complex cuff tears (involving subscapularis tendon or more than one tendon besides supra and infraspinatus, or massive dimension tears)
* Glenohumeral arthritis
* Irreparable tendon defect
* Patients with concomitant neurological disorders (ex. Stroke, Parkinson´s disease, multiple sclerosis)
* Aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process
* Respiratory, cardiac, metabolic conditions or others incompatible with at least 30 minutes of light to moderate physical activity
* Major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after surgery
* Other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program
* Blind and/or illiterate patients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Constant Score Test
Timeframe: Baseline, 8 weeks after surgery, 12 (and 16) weeks.