Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Surgeons Scale (ASES) - Functionality.
研究概览
简要总结
The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients.
详细描述
Background: Shoulder fractures, shoulder osteoarthritis and rheumatoid arthritis have a high prevalence and many times they require a surgery, in which a reverse shoulder phrostesis is colocated. Nonetheless, nowadays there is no a clear consensus protocol in order to manage the prehabilitation and rehabilitation of this patient, so each physiotherapist use different techniques to treat this pathology.
Objective
This study aims to evaluate the effectiveness of an original intervention program (REMOVE program) focused on an early intervention based on therapeutic exercise, manual therapy and education to improve the functionality of these patients after surgery.
Methods: This study is a randomized controlled trial with parallel groups. The control group receive standard care, and the experimental group is subjected to the REMOVE program. Both groups are evaluated five times, pre-surgery, at baseline, at 6 weeks, at 12 weeks and at 24 weeks to assess psychometric and laboratory outcomes.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with a reverse shoulder prosthesis.
- •Age between 18 and 90 years.
- •Signed informed consent.
排除标准
- •Language or cultural barriers.
- •Other upper limb injury.
- •Treatment that affect physical activity capacity.
研究组 & 干预措施
CONTROL GROUP - STANDARD PHYSIOTHERAPY
Patients will undergo standard care which consists of an initial consultation with the physiotherapist to receive some recommendations about exercises, progression and health education
干预措施: CONTROL (Other)
EXPERIMENTAL GROUP - REMOVE PROGRAM
INITIAL STAGE:
- Aim: Recover mobility
- Exercises: Passive therapy, isometric exercises focused on middle deltoid.
- Goal: 80º passive flexion, 45º abduction, 5 N of abduction force STRENGTHENING STAGE
- Aim: Enhance scapulohumeral rhythm and strength rotator cura
- Exercises: Active-assisted therapy, isotonic exercises between 45-90º of forward flexión and abduction with dumbbells and isometric exercises focused on internal and external rotation.
- Goal: 100º passive flexion, 90º lateral abduction, 10 N of abduction force INTENSIVE STAGE
- Aim: Improve motor control and increase cross-sectional muscular área
- Exercises: Rowe with resistance band, wall push ups, lateral elevation with dumbbles, active external and internal rotation.
- Goal: 15 N of abduction force FUNCTIONAL STAGE
- Aim: Develope daily life activities
- Exercises: Overhead tasks, rowe with Kettlebell, internal and external rotations with resistance bands
- Goal: 20 N of abduction force
干预措施: REMOVE (Other)
结局指标
主要结局
American Shoulder and Elbow Surgeons Scale (ASES) - Functionality.
时间窗: BASELINE, 12 WEEKS, 24 WEEKS
This tool is used to evaluate functionality and shoulder-related problems. This scale contains demographic data, medical evaluation, and self-reported outcomes, with a visual analog scale (VAS) to report pain, and 10 items regarding daily life activities. The score is calculated: \[(10 - score obtained in VAS) x 5\] + (5/3 x score obtained in daily life activities)\]. The worst result is 0 points and the best one is 100 points.
次要结局
- Ultrasound image - Muscle thickness in centimeters.(BASELINE, 12 WEEKS, 24 WEEKS)
- Inertial sensors - Linear acceleration and angular velocity(BASELINE, 12 WEEKS, 24 WEEKS)
- Dynamometer - Strength in Newtons.(BASELINE, 12 WEEKS, 24 WEEKS)
- Goniometer - Range of motion in degrees.(BASELINE, 12 WEEKS, 24 WEEKS)
- Constant-Murley Score (CS) - Functionality(BASELINE, 12 WEEKS, 24 WEEKS)
- University of California - Los Angeles Shoulder Scale (UCLA) - Functionality.(BASELINE, 12 WEEKS, 24 WEEKS)
- Simple Shoulder Test (SST) - Functionality.(BASELINE, 12 WEEKS, 24 WEEKS)
- Physiological fatigue - high density electromyography(Baseline, 6 Weeks, 12 weeks, 24 weeks.)
- Kinematics - Motion capture system(Baseline, 6 weeks, 12 weeks, 24 weeks.)
研究者
Dr. Antonio I Cuesta-Vargas
Principal Investigator
University of Malaga