Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

NCT03648047 | Terminated DMC

• 1 other identifier: SH-RCT-ARCR-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in QuickDASH score

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

• Change in Shoulder Range of Motion

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

Study Arms (2)

Experimental group

EXPERIMENTAL

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; Other: Additional face-to-face rehabilitation sessions

Conventional rehabilitation

ACTIVE COMPARATOR

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

Interventions

Digital kinematic biofeedback device DEVICE

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

Also known as: SWORD Phoenix

Experimental group

Conventional rehabilitation OTHER

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

Conventional rehabilitation

Additional face-to-face rehabilitation sessions OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sword Health, SA: lead
• Hospital da Prelada: collaborator

Study Sites (1)

Hospital da Prelada

Porto, 4250-449, Portugal

Location

Related Publications (1)

• 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.

  PMID: 33935152 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Fernando D Correia, MD

  SWORD Health

  PRINCIPAL INVESTIGATOR

• Rosmaninho Seabra, MD

  Hospital da Prelada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All patients will be assessed by an independent outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: November 11, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

PT (1)