Rotator Cuff Tear
Conditions
Brief 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.
Interventions
DEVICEDigital kinematic biofeedback device
The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team.
OTHERConventional rehabilitation
Patients will receive conventional face-to-face sessions by a Physical Therapist.
OTHERAdditional face-to-face rehabilitation sessions
Patients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device
Sponsors
Hospital da Prelada
Sword Health, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All patients will be assessed by an independent outcomes assessor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Constant Score Test | Baseline, 8 weeks after surgery, 12 (and 16) weeks. | The Constant Score is a functional assessment score specific to the shoulder region. It is the most used instrument to assess the shoulder in Europe and its psychometric properties prove it to be a valid, reliable and responsive measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QuickDASH score | Baseline, 8 weeks after surgery, 12 (and16) weeks. | The QuickDASH is an 11-item self-administered outcome measure, specific to measure disability and symptoms in individuals with musculoskeletal disorders of the upper limb.It is an instrument widely used for clinical or research purposes and which has proven to be a valid, reliable and responsive measure. |
| Change in Shoulder Range of Motion | Baseline, 8 weeks after surgery, 12 (and16) weeks. | Shoulder range of motion (in degrees) in the following exercises: sitting external rotation/abduction/flexion; lying internal/external rotation with 90º shoulder abduction |
Countries
Portugal
Outcome results
None listed