The ISEO Biofeedback Tool During the Rehabilitation of Patients Treated for Rotator Cuff Tear (PDT1-1)

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Status: Completed

Conditions: Rotator Cuff Tears

Treatments: Device: Kinematic biofeedback with ISEO motion analysis system

Study type: Interventional

Funder types: Other

Identifiers

NCT04521504

PDT1-1

Details and patient eligibility

About

The present study addresses the issue about post-surgical recovery process, for patients arthroscopically treated for rotator-cuff tear. The aim of the research is to test the effectiveness of a new rehabilitation protocol that includes kinematic biofeedback with the motion analysis system ISEO.

Full description

The research includes at least 62 patients arthroscopically treated for the rotator cuff tear. For this purpose, two groups of patients of equal size are identified. The attribution of each patient to one of the two groups is random. The standard rehabilitation protocol is applied to the Control group (Group A), whereas the standard rehabilitation protocol integrated by proprioception exercises (physical therapist assisted) performed with ISEO is applied to the Experimental group (Group B). The primary objective is to verify if the ISEO system, used as a biofeedback tool, improves shoulder functionality and activity of patients arthroscopically treated for rotator cuff tear, both in the short (90 days from surgery) and in the medium term (6-12 months from surgery). All patients are longitudinally evaluated from the pre-surgery to a 6/12 months follow-up. Each evaluation includes both a clinical and an instrumented assessment of shoulder kinematics. The primary outcome tested is the Scapula-Weighted Constant-Murley Score, which represents a reformulation of the Constant-Murley Score, which is modified based on the quality of the scapular movement measured with ISEO.

Enrollment: 46 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with rotator cuff injuries;
• asymptomatic contralateral shoulder, that can be considered as a reference for the differential evaluation;
• indication for arthroscopy;
• employees;
• rehabilitation executed at AUSL-Romagna.

Exclusion criteria

• irreparable injuries of the rotator cuff;
• contralateral painful shoulder;
• patients being treated for cancer in the last 6 months;
• patients with concomitant neurological pathologies;
• patients with spinal cord injuries;
• patients with cuff lesions with infectious processes;
• patients with severe scoliosis;
• patients with recurrent lesions of the cuff;
• patients with occupational diseases or work-related accidents;
• patients for whom the return to work cannot be reliably established.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Biofeedback

Experimental group

Description:

Patients were treated with an experimental rehabilitation protocol, based on shoulder kinematic biofeedback.

Treatment:

Device: Kinematic biofeedback with ISEO motion analysis system

Control

No Intervention group

Description:

Patients were treated with a standard rehabilitation protocol, based on hospital guidelines.