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Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT03648047
Recruitment Status : Terminated (COVID-19 pandemic imposed restrictions to normal study conduct)
First Posted : August 27, 2018
Last Update Posted : September 1, 2020
Sponsor:
Collaborator:
Hospital da Prelada
Information provided by (Responsible Party):
Sword Health, SA

Tracking Information
First Submitted Date  ICMJE August 23, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date September 1, 2020
Actual Study Start Date  ICMJE November 11, 2018
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
Change in Constant Score Test [ Time Frame: Baseline, 8 weeks after surgery, 12, 16, 20 (and 24) 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Change in QuickDASH score [ Time Frame: Baseline, 8 weeks after surgery, 12, 16, 20 (and 24) 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 [ Time Frame: Baseline, 8 weeks after surgery, 12, 16, 20 (and 24) weeks. ]
    Shoulder range of motion (in degrees) in the following exercises: sitting external rotation/abduction/flexion; lying internal/external rotation with 90º shoulder abduction
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair
Official Title  ICMJE Efficacy of a Digital Kinematic Biofeedback System for Rehabilitation After Arthroscopic Rotator Cuff Repair Versus Conventional In-person Rehabilitation: a Randomized Controlled Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Rotator Cuff Tear
Intervention  ICMJE
  • 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: Conventional rehabilitation
    Patients will receive conventional face-to-face sessions by a Physical Therapist.
  • Other: Additional face-to-face rehabilitation sessions
    Patients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Digital kinematic biofeedback device
    • Other: Additional face-to-face rehabilitation sessions
  • 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.
    Intervention: Other: Conventional rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2020)
50
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
80
Actual Study Completion Date  ICMJE April 1, 2020
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03648047
Other Study ID Numbers  ICMJE SH-RCT-ARCR-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party Sword Health, SA
Study Sponsor  ICMJE Sword Health, SA
Collaborators  ICMJE Hospital da Prelada
Investigators  ICMJE
Principal Investigator: Fernando D Correia, MD SWORD Health
Study Chair: Rosmaninho Seabra, MD Hospital da Prelada
PRS Account Sword Health, SA
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP