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Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

NCT03648047 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-09-01

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Hospital da Prelada

    collaborator OTHER

  • Sword Health, SA

    lead INDUSTRY

Principal Investigators

  • Fernando D Correia, MD · SWORD Health

  • Rosmaninho Seabra, MD · Hospital da Prelada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-11
Primary Completion
2020-04-01
Completion
2020-04-01

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03648047 on ClinicalTrials.gov