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Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tear

Status

Terminated

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Digital kinematic biofeedback device

Conventional rehabilitation

Additional face-to-face rehabilitation sessions

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital da Prelada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Conventional rehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT03648047

First Posted

August 23, 2018

Last Updated

August 28, 2020

Sponsor

Sword Health, SA

Collaborators

Hospital da Prelada

1. Study Identification

Unique Protocol Identification Number

NCT03648047

Brief Title

Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

COVID-19 pandemic imposed restrictions to normal study conduct

Study Start Date

November 11, 2018 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sword Health, SA

Collaborators

Hospital da Prelada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tear

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

All patients will be assessed by an independent outcomes assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Arm Title

Conventional rehabilitation

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Digital kinematic biofeedback device

Other Intervention Name(s)

SWORD Phoenix

Intervention Description

The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team.

Intervention Type

Other

Intervention Name(s)

Conventional rehabilitation

Intervention Description

Patients will receive conventional face-to-face sessions by a Physical Therapist.

Intervention Type

Other

Intervention Name(s)

Additional face-to-face rehabilitation sessions

Intervention Description

Patients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device

Primary Outcome Measure Information:

Title

Change in Constant Score Test

Description

Time Frame

Baseline, 8 weeks after surgery, 12 (and 16) weeks.

Secondary Outcome Measure Information:

Title

Change in QuickDASH score

Description

Time Frame

Baseline, 8 weeks after surgery, 12 (and16) weeks.

Title

Change in Shoulder Range of Motion

Description

Shoulder range of motion (in degrees) in the following exercises: sitting external rotation/abduction/flexion; lying internal/external rotation with 90º shoulder abduction

Time Frame

Baseline, 8 weeks after surgery, 12 (and16) weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando D Correia, MD

Organizational Affiliation

SWORD Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rosmaninho Seabra, MD

Organizational Affiliation

Hospital da Prelada

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital da Prelada

City

Porto

ZIP/Postal Code

4250-449

Country

Portugal

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Study protocol and study aggregate results (including anonymised individual patient data) will be made available

IPD Sharing Time Frame

The data will become available upon study publication, for 5 years.

IPD Sharing 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.

IPD Sharing URL

https://drive.google.com/file/d/1BBfowtHXm4U91QTRPilzvxOFglKx3T_h/view?usp=sharing

Citations:

PubMed Identifier

33935152

Citation

Correia FD, Molinos M, Luis 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.

Results Reference

derived

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Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

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