The ISEO Biofeedback Tool During the Rehabilitation of Patients Treated for Rotator Cuff Tear

NCT ID: NCT04521504

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-21
• Study Completion Date: 2020-02-27

Brief Summary

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.

Detailed 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.

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biofeedback

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

Group Type: EXPERIMENTAL

Kinematic biofeedback with ISEO motion analysis system

Intervention Type: DEVICE

Exercises are performed with the help of the ISEO motion analysis system, that provides a real-time biofeedback of shoulder kinematics. All exercises are administered by the Physical Therapist.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Kinematic biofeedback with ISEO motion analysis system

Exercises are performed with the help of the ISEO motion analysis system, that provides a real-time biofeedback of shoulder kinematics. All exercises are administered by the Physical Therapist.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AUSL Romagna Rimini

OTHER

Sponsor Role: collaborator

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria V Filippi, MD

Role: PRINCIPAL_INVESTIGATOR

AUSL della Romagna

Paolo Paladini, MD

Role: STUDY_DIRECTOR

AUSL della Romagna

Riccardo Galassi, MD

Role: STUDY_DIRECTOR

AUSL della Romagna

Locations

AUSL della Romagna - Cervesi Hospital

Cattolica, Rimini, Italy

Countries

Italy

References

Parel I, Jaspers E, DE Baets L, Amoresano A, Cutti AG. Motion analysis of the shoulder in adults: kinematics and electromyography for the clinical practice. Eur J Phys Rehabil Med. 2016 Aug;52(4):575-82. Epub 2016 Jul 19.

Reference Type: BACKGROUND

PMID: 27434612 (View on PubMed)

Cutti AG, Parel I, Pellegrini A, Paladini P, Sacchetti R, Porcellini G, Merolla G. The Constant score and the assessment of scapula dyskinesis: Proposal and assessment of an integrated outcome measure. J Electromyogr Kinesiol. 2016 Aug;29:81-9. doi: 10.1016/j.jelekin.2015.06.011. Epub 2015 Jul 6.

Reference Type: BACKGROUND

PMID: 26184668 (View on PubMed)

Cutti AG, Parel I, Raggi M, Petracci E, Pellegrini A, Accardo AP, Sacchetti R, Porcellini G. Prediction bands and intervals for the scapulo-humeral coordination based on the Bootstrap and two Gaussian methods. J Biomech. 2014 Mar 21;47(5):1035-44. doi: 10.1016/j.jbiomech.2013.12.028. Epub 2014 Jan 13.

Reference Type: BACKGROUND

PMID: 24485513 (View on PubMed)

Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.

Reference Type: BACKGROUND

PMID: 18218327 (View on PubMed)

Other Identifiers

PDT1-1

Identifier Type: -

Identifier Source: org_study_id