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

The Use of the Motion Analysis System ISEO, as a Biofeedback Tool During the Rehabilitation Process of Patients Surgically Treated for Rotator Cuff Tear

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Device: Kinematic biofeedback with ISEO motion analysis system

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rimini
    • Cattolica, Rimini, Italy, 47841
      • AUSL della Romagna - Cervesi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofeedback; Patients were treated with an experimental rehabilitation protocol, based on shoulder kinematic biofeedback.	Device: 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.
No Intervention: Control; Patients were treated with a standard rehabilitation protocol, based on hospital guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant-Murley Score (CMS)	The CMS is a standard questionnaire for the evaluation of patients with shoulder diseases, one of the most widespread in Europe. The Score varies between 0 (worse) and 100 (best) points.	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)	The ASES is a very popular questionnaire (in particular in the USA), partly completed from the patient and partly completed from the doctor. The part dedicated to the patient provides for an assessment of pain, instability and daily life activities. The part filled in by the doctor includes 4 items on tenderness. The ASES varies between 0 (worse) and 100 (best) points.	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)	The DASH is a very popular questionnaire that quantifies the level of disability of a patient with upper limb disease. The questionnaire is a self-administered by the patient. The DASH varies between 0 (best) and 100 (worse) points.	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)	The EQ-5D is a standard questionnaire for the measure of health outcome. EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The EQ-5D varies between 0 (worse) and 100 (best) points.	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)	The sEMG is the electrical activity of shoulder superficial muscles. Muscles acquired are: Deltoid (anterior and posterior), Trapezius (upper, medium and lower), Serratus Anterior, Pectoralis Major and Latissimus Dorsi.	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).
Pectoralis Minor length	Pectoralis Minor length in mm	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).
Body Mass Index (BMI)	The BMI is measure in kg/m^2	Before surgery
Cervical pain: Presence of cervical pain YES or NOT. If YES, why	It is measured by the Doctor as follows: Presence of cervical pain YES or NOT. If YES, why.	Before surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of job-change	Percentage of patients that had to change their job	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	Evaluation of the satisfaction of the patient during the rehabilitation period. The score varies from 0 (totally unsatisfied) and 10 (totally satisfied).	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).

Collaborators and Investigators

• Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
• Collaborators: AUSL Romagna Rimini
• Investigators: Principal Investigator: Maria V Filippi, MD, AUSL della Romagna; Study Director: Paolo Paladini, MD, AUSL della Romagna; Study Director: Riccardo Galassi, MD, AUSL della Romagna

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): February 27, 2020
• Study Completion (Actual): February 27, 2020

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Shoulder; Biofeedback; Kinematics
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: PDT1-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No