Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

• ClinicalTrials.gov Identifier: NCT03648047
• Recruitment Status: Terminated
• First Posted: August 27, 2018
• Last Update Posted: September 1, 2020
• Sponsor: Sword Health, SA
• Collaborator: Hospital da Prelada
• Information provided by (Responsible Party): Sword Health, SA

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Tear	Device: Digital kinematic biofeedback device; Other: Conventional rehabilitation; Other: Additional face-to-face rehabilitation sessions	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: All patients will be assessed by an independent outcomes assessor
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 11, 2018
• Actual Primary Completion Date: April 1, 2020
• Actual Study Completion Date: April 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental group; 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.	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 Name: SWORD Phoenix; Other: Additional face-to-face rehabilitation sessions; Patients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device
Active Comparator: 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.	Other: Conventional rehabilitation; Patients will receive conventional face-to-face sessions by a Physical Therapist.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change in QuickDASH score [ Time Frame: 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.
2. Change in Shoulder Range of Motion [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Portugal

Hospital da Prelada

Porto, Portugal, 4250-449

Sponsors and Collaborators

Sword Health, SA

Hospital da Prelada

Investigators

• Principal Investigator: Fernando D Correia, MD; SWORD Health
• Study Chair: Rosmaninho Seabra, MD; Hospital da Prelada

  Study Documents (Full-Text)

Documents provided by Sword Health, SA:

Study Protocol and Statistical Analysis Plan  [PDF] June 14, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Correia FD, Molinos M, Luís 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.

• Responsible Party: Sword Health, SA
• ClinicalTrials.gov Identifier: NCT03648047
• Other Study ID Numbers: SH-RCT-ARCR-01
• First Posted: August 27, 2018
• Last Update Posted: September 1, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Study protocol and study aggregate results (including anonymised individual patient data) will be made available
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: The data will become available upon study publication, for 5 years.
• Access Criteria: Study protocol will be available through a direct link in this platform. The excel file with the aggregate results will be made available as supplementary information upon study publication.
• URL: https://drive.google.com/file/d/1BBfowtHXm4U91QTRPilzvxOFglKx3T_h/view?usp=sharing

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries