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

NCT04521504 | Completed DMC

• 1 other identifier: PDT1-1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Keywords

Shoulder; Biofeedback; Kinematics

Outcome Measures

Primary Outcomes (3)

• The Scapula-Weighted Constant-Murley Score (SW-CMS) at T3

  The SW-CMS is a modified version of the CMS, based on the quality of the movement of the scapula: the score referred to humerus elevation is "weighted" based on scapula movement. The Score varies between 0 (worse) and 100 (best) points.

  90 days after surgery

• The Scapula-Weighted Constant-Murley Score (SW-CMS) at T5A

  The SW-CMS is a modified version of the CMS, based on the quality of the movement of the scapula: the score referred to humerus elevation is "weighted" based on scapula movement. The Score varies between 0 (worse) and 100 (best) points.

  6 months after surgery

• The Scapula-Weighted Constant-Murley Score (SW-CMS) at T5B

  The SW-CMS is a modified version of the CMS, based on the quality of the movement of the scapula: the score referred to humerus elevation is "weighted" based on scapula movement. The Score varies between 0 (worse) and 100 (best) points.

  12 months after surgery

Secondary Outcomes (8)

• Constant-Murley Score (CMS)

  T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery).

• American Shoulder and Elbow Score (ASES)

  T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery).

• Disabilities of the Arm, Shoulder and Hand (DASH)

  T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery).

• EuroQol five-dimension scale (EQ-5D)

  T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery).

• Superficial Electromyography (sEMG)

  T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery).

Other Outcomes (2)

• Percent of job-change

  T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery).

• Degree of satisfaction of the patient: score

  T0 (before surgery), T1 (45 days after surgery), T3 (90 days after surgery), T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery).

Study Arms (2)

Biofeedback

EXPERIMENTAL

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

Device: Kinematic biofeedback with ISEO motion analysis system

Control

NO INTERVENTION

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

Interventions

Kinematic biofeedback with ISEO motion analysis system 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.

Biofeedback

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro: lead
• AUSL Romagna Rimini: collaborator

Study Sites (1)

AUSL della Romagna - Cervesi Hospital

Cattolica, Rimini, 47841, Italy

Location

Related Publications (4)

• 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.

  PMID: 27434612 BACKGROUND

• 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.

  PMID: 26184668 BACKGROUND

• 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.

  PMID: 24485513 BACKGROUND

• 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.

  PMID: 18218327 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Maria V Filippi, MD

  AUSL della Romagna

  PRINCIPAL INVESTIGATOR

• Paolo Paladini, MD

  AUSL della Romagna

  STUDY DIRECTOR

• Riccardo Galassi, MD

  AUSL della Romagna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study considers participants divided in two groups: the control group and the experimental group.

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 20, 2020
• Study Start: November 21, 2017
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)