Efficacy of a Digital Kinematic Biofeedback System for Rehabilitation After Arthroscopic Rotator Cuff Repair Versus Conventional In-person Rehabilitation: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Constant Score Test
研究概览
简要总结
This study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital kinematic biofeedback system against conventional in-person home-based rehabilitation, with the intent of reducing the need for face-to-face sessions.
The investigators hypothesize that the clinical outcomes of such a program will be at least similar to those of conventional rehabilitation.
Patients will be enrolled pre-operatively and then randomized into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform a 12 to 16-week rehabilitation program starting immediately after surgery.
Outcomes will be measured at baseline, 8 and 12 weeks. In patients where a decision is made to extend the program to 16 weeks, another assessment will be made at this point.
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
- Single (Outcomes Assessor)
盲法说明
All patients will be assessed by an independent outcomes assessor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Shoulder pain and functional limitation with clinical examination compatible with rotator cuff tendinopathy
- •Imaging (MRI or ultrasound) evidence of rotator cuff tear (supra and/or infraspinatus tendon tear inferior to 3 cm? or 5cm?)
- •Indication for a simple rotator cuff repair according to the patient´s orthopedic surgeon
- •Ability to understand simple and complex motor commands
- •Availability of a carer to assist the patient after surgery
排除标准
- •Patients admitted for revision cuff repair
- •Complex cuff tears (involving subscapularis tendon or more than one tendon besides supra and infraspinatus, or massive dimension tears)
- •Glenohumeral arthritis
- •Irreparable tendon defect
- •Patients with concomitant neurological disorders (ex. Stroke, Parkinson´s disease, multiple sclerosis)
- •Aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process
- •Respiratory, cardiac, metabolic conditions or others incompatible with at least 30 minutes of light to moderate physical activity
- •Major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after surgery
- •Other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program
- •Blind and/or illiterate patients
结局指标
主要结局
Change in Constant Score Test
时间窗: Baseline, 8 weeks after surgery, 12 (and 16) weeks.
The Constant Score is a functional assessment score specific to the shoulder region. It is the most used instrument to assess the shoulder in Europe and its psychometric properties prove it to be a valid, reliable and responsive measure.
次要结局
- Change in QuickDASH score(Baseline, 8 weeks after surgery, 12 (and16) weeks.)
- Change in Shoulder Range of Motion(Baseline, 8 weeks after surgery, 12 (and16) weeks.)