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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Device: Kinematic biofeedback with ISEO motion analysis system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study considers participants divided in two groups: the control group and the experimental group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback<br>Patients were treated with an experimental rehabilitation protocol, based on shoulder kinematic biofeedback. | Device: Kinematic biofeedback with ISEO motion analysis system<br>* 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.<br>|
| No Intervention: Control<br>Patients were treated with a standard rehabilitation protocol, based on hospital guidelines. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Biofeedback, Kinematics