The Use of the Motion Analysis System ISEO, as a Biofeedback Tool During the Rehabilitation Process of Patients Surgically Treated for Rotator Cuff Tear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The Scapula-Weighted Constant-Murley Score (SW-CMS) at T5B
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Biofeedback
Patients were treated with an experimental rehabilitation protocol, based on shoulder kinematic biofeedback.
干预措施: Kinematic biofeedback with ISEO motion analysis system (Device)
Control
Patients were treated with a standard rehabilitation protocol, based on hospital guidelines.
结局指标
主要结局
The Scapula-Weighted Constant-Murley Score (SW-CMS) at T5B
时间窗: 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.
The Scapula-Weighted Constant-Murley Score (SW-CMS) at T3
时间窗: 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.
The Scapula-Weighted Constant-Murley Score (SW-CMS) at T5A
时间窗: 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.
次要结局
- Cervical pain: Presence of cervical pain YES or NOT. If YES, why(Before surgery)
- 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).)
- Pectoralis Minor length(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)(Before 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).)
- 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).)