Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

Not Applicable

Terminated

• Conditions: Rotator Cuff Tear
• Interventions: Other: Conventional rehabilitation; Device: Digital kinematic biofeedback device; Other: Additional face-to-face rehabilitation sessions

• Registration Number: NCT03648047
• Lead Sponsor: Sword Health, SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Study Start: 2018-11-11
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-28
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Additional face-to-face rehabilitation sessions	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.
Conventional rehabilitation	Conventional rehabilitation	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.
Experimental group	Digital kinematic biofeedback device	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital da Prelada; 🇵🇹 Porto, Portugal