Clinical trial NCT03648047: Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair
Official title: Efficacy of a Digital Kinematic Biofeedback System for Rehabilitation After Arthroscopic Rotator Cuff Repair Versus Conventional In-person Rehabilitation: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
Collaborators: name: Hospital da Prelada
First posted: 2018-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Constant Score Test
timeFrame: Baseline, 8 weeks after surgery, 12 (and 16) weeks.
Secondary outcomes:
measure: Change in QuickDASH score
timeFrame: Baseline, 8 weeks after surgery, 12 (and16) weeks.
measure: Change in Shoulder Range of Motion
timeFrame: Baseline, 8 weeks after surgery, 12 (and16) weeks.
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Hospital da Prelada
Study officials:
affiliation: SWORD Health
name: Fernando D Correia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital da Prelada
name: Rosmaninho Seabra, MD
role: STUDY_CHAIR
References:
citation: Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):237-249. doi: 10.1097/PHM.0000000000001780.