Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

SWORD Health

Status: Terminated

Conditions: Rotator Cuff Tear

Treatments: Other: Additional face-to-face rehabilitation sessions; Other: Conventional rehabilitation; Device: Digital kinematic biofeedback device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03648047

SH-RCT-ARCR-01

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Experimental group

Experimental group

Description:

Patients in this group will receive a mixed home-based rehabilitation program consisting of face-to-face sessions with a Physical Therapist (with decreasing periodicity depending on program stage) as well as sessions performed with a digital kinematic biofeedback system.

Treatment:

Device: Digital kinematic biofeedback device

Other: Additional face-to-face rehabilitation sessions

Conventional rehabilitation

Active Comparator group

Description:

Patients in this group will receive a home-based rehabilitation program consisting of face-to-face sessions with a Physical Therapist 3 times per week, for 1 hour. Patients will also be instructed to perform additional unsupervised sessions in at least two other days of the week. Compliance to these additional sessions is not mandatory, but patients will be asked to fill in a diary regarding these extra-sessions.

Treatment:

Other: Conventional rehabilitation