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Completed

NCT Number: NCT04521504

The ISEO Biofeedback Tool During the Rehabilitation of Patients 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.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AUSL della Romagna - Cervesi Hospital

Cattolica, Rimini, 47841, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 90 days after surgery

    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.

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

    Time frame: 6 months after surgery

    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.

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

    Time frame: 12 months after surgery

    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.

Secondary outcomes

  1. Constant-Murley Score (CMS)

    Time frame: 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).

    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.

  2. American Shoulder and Elbow Score (ASES)

    Time frame: 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).

    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.

  3. Disabilities of the Arm, Shoulder and Hand (DASH)

    Time frame: 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).

    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.

  4. EuroQol five-dimension scale (EQ-5D)

    Time frame: 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).

    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.

  5. Superficial Electromyography (sEMG)

    Time frame: 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).

    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.

  6. Pectoralis Minor length

    Time frame: 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 in mm

  7. Body Mass Index (BMI)

    Time frame: Before surgery

    The BMI is measure in kg/m^2

  8. Cervical pain: Presence of cervical pain YES or NOT. If YES, why

    Time frame: Before surgery

    It is measured by the Doctor as follows:

    Presence of cervical pain YES or NOT. If YES, why.

Other outcomes

  1. Percent of job-change

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

    Percentage of patients that had to change their job

  2. Degree of satisfaction of the patient: score

    Time frame: 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).

    Evaluation of the satisfaction of the patient during the rehabilitation period. The score varies from 0 (totally unsatisfied) and 10 (totally satisfied).

Sponsors and collaborators

Lead sponsor

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Other

Collaborators

  • AUSL Romagna Rimini

Registry information

Official study title

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

Acronym: PDT1-1

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 20, 2020
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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