Efficacy of a Digital Kinematic Biofeedback System for Rehabilitation After Arthroscopic Rotator Cuff Repair Versus Conventional In-person Rehabilitation: a Randomized Controlled Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tear
- Sponsor
- Sword Health, SA
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Constant Score Test
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Constant Score Test
Time Frame: 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 Outcomes
- Change in QuickDASH score(Baseline, 8 weeks after surgery, 12 (and16) weeks.)
- Change in Shoulder Range of Motion(Baseline, 8 weeks after surgery, 12 (and16) weeks.)