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 range18 Years

SexALL

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

What they're measuring

Change in Constant Score Test

Timeframe: Baseline, 8 weeks after surgery, 12 (and 16) weeks.

Trial details

NCT IDNCT03648047

SponsorSword Health, SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-01