Clinical trial NCT04521504: The ISEO Biofeedback Tool During the Rehabilitation of Patients Treated for Rotator Cuff Tear
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: Shoulder
Biofeedback
Kinematics
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
Collaborators: name: AUSL Romagna Rimini
First posted: 2020-08-20
Enrollment: 46
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study considers participants divided in two groups: the control group and the experimental group.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Scapula-Weighted Constant-Murley Score (SW-CMS) at T3
timeFrame: 90 days after surgery
measure: The Scapula-Weighted Constant-Murley Score (SW-CMS) at T5A
timeFrame: 6 months after surgery
measure: The Scapula-Weighted Constant-Murley Score (SW-CMS) at T5B
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Constant-Murley Score (CMS)
timeFrame: 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).
measure: American Shoulder and Elbow Score (ASES)
timeFrame: 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).
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 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).
measure: EuroQol five-dimension scale (EQ-5D)
timeFrame: 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).
measure: Superficial Electromyography (sEMG)
timeFrame: 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).
measure: Pectoralis Minor length
timeFrame: 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).
measure: Body Mass Index (BMI)
timeFrame: Before surgery
measure: Cervical pain: Presence of cervical pain YES or NOT. If YES, why
timeFrame: Before surgery
Other outcomes:
measure: Percent of job-change
timeFrame: T4 (return-to-work time, up to 24 weeks), T5A (6 months after surgery) and T5B (12 months after surgery).
measure: Degree of satisfaction of the patient: score
timeFrame: 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).
Locations:
city: Cattolica
country: Italy
facility: AUSL della Romagna - Cervesi Hospital
state: Rimini
Study officials:
affiliation: AUSL della Romagna
name: Maria V Filippi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AUSL della Romagna
name: Paolo Paladini, MD
role: STUDY_DIRECTOR
affiliation: AUSL della Romagna
name: Riccardo Galassi, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.