Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648047
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Hospital da Prelada
Information provided by (Responsible Party):
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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648047


Contacts
Layout table for location contacts
Contact: Fernando D Correia, MD +351 966557789 fcorreia@swordhealth.com
Contact: Andre Nogueira +351 919000190 anogueira@swordhealth.com

Locations
Layout table for location information
Portugal
Hospital da Prelada Recruiting
Porto, Portugal, 4250-449
Contact: Rosmaninho Seabra, MD    228 330 600    rosmaninho.seabra@hospitaldaprelada.pt   
Sponsors and Collaborators
Sword Health, SA
Hospital da Prelada
Investigators
Layout table for investigator information
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:

Layout table for additonal information
Responsible Party: Sword Health, SA
ClinicalTrials.gov Identifier: NCT03648047    
Other Study ID Numbers: SH-RCT-ARCR-01
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries