Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03648047
• Other study ID #: SH-RCT-ARCR-01
• Status: Terminated
• Phase: N/A
• Start date: November 11, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2020
• Source: Sword Health, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Device:
• Digital 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.

Other:
• Conventional rehabilitation
Patients will receive conventional face-to-face sessions by a Physical Therapist.
• Additional face-to-face rehabilitation sessions
Patients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device

Locations

Country	Name	City	State
Portugal	Hospital da Prelada	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Sword Health, SA	Hospital da Prelada

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Constant Score Test	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.	Baseline, 8 weeks after surgery, 12 (and 16) weeks.
Secondary	Change in QuickDASH score	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.	Baseline, 8 weeks after surgery, 12 (and16) weeks.
Secondary	Change in Shoulder Range of Motion	Shoulder range of motion (in degrees) in the following exercises: sitting external rotation/abduction/flexion; lying internal/external rotation with 90º shoulder abduction	Baseline, 8 weeks after surgery, 12 (and16) weeks.