Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

NCT ID: NCT03648047

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-11
• Study Completion Date: 2020-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital kinematic biofeedback device

Intervention Type: DEVICE

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

Additional face-to-face rehabilitation sessions

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Conventional rehabilitation

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

Intervention Type: OTHER

Additional face-to-face rehabilitation sessions

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

Intervention Type: OTHER

Other Intervention Names

SWORD Phoenix

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital da Prelada

OTHER

Sponsor Role: collaborator

Sword Health, SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando D Correia, MD

Role: PRINCIPAL_INVESTIGATOR

SWORD Health

Rosmaninho Seabra, MD

Role: STUDY_CHAIR

Hospital da Prelada

Locations

Hospital da Prelada

Porto, , Portugal

Countries

Portugal

References

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.

Reference Type: DERIVED

PMID: 33935152 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SH-RCT-ARCR-01

Identifier Type: -

Identifier Source: org_study_id