The Effect of Physiotherapist Supervised Training on Neuromuscular Control in Patients With Traumatic Anterior Shoulder Instability
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Neuromuscular control - Shouldersway
研究概览
简要总结
The goal of this clinical trial is to investigate if physiotherapist supervised training improves neuromuscular control in patients suffering from traumatic anterior shoulder instability. The main question(s) it aims to answer are:
- Does physiotherapist supervised training improve shoulder neuromuscular control
- Does physiotherapist supervised training prevent recurring shoulder dislocations
- Is physiotherapist supervised training as good as surgery in improving shoulder neuromuscular control Participants will be randomised to either a training group or a no-training group.
Participants in the training group will undergo a 12 week training-program supervised by a physiotherapist.
Participants in the no-training group will receive a consultation with a shoulder surgeon, where information and general advice regarding the shoulder injury is provided.
Researchers will compare the training group to the no-training group to see if physiotherapist supervised training improves shoulder neuromuscular control in patients with traumatic anterior shoulder instability. The training group will also be compared to a historic group of patients with traumatic anterior shoulder instability, who underwent arthroscopic surgery.
详细描述
- Aim: To investigate the effect of physiotherapist supervised training on shoulder neuromuscular control, and increase understanding of traumatic anterior shoulder instability.
- Main research questions:
A: Is supervised training in patients with traumatic anterior shoulder instability better in improving neuromuscular control, strength, apprehension and patient reported outcomes when compared to no training.
B: Is supervised training in patients with traumatic anterior shoulder instability better in preventing re-dislocations and need for surgical stabilisation when compared to no training.
C: Is supervised training in patients with traumatic anterior shoulder as good as Bankart surgery in improving neuromuscular control and patient reported outcome when compared to no training.
• Objectives for research question A:
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 years.
- •Unilateral traumatic anterior shoulder instability.
- •Willingness to adhere to the study protocol, herein attend follow-up.
- •Ability to speak, read, and understand Danish.
- •Ability to give written informed consent.
排除标准
- •Instability in the opposite shoulder.
- •Off-track lesion.
- •For both shoulders: Former or planned surgery.
- •For both shoulders: posterior, multi-directional or atraumatic instability.
- •For both shoulders: traumatic rotator cuff or biceps tendon tear.
- •For both shoulders: traumatic fracture of proximal humerus (other than Hill-Sachs lesion), clavicula, scapula (other than glenoid) or dislocation of sternoclavicular or acromioclavicular joints.
- •For both shoulders: atraumatic shoulder pathologies (e.g. frozen shoulder, symptomatic osteoarthritis of the shoulder or acromioclavicular joints, acute tendinitis calcarean).
- •Pregnancy.
- •Terminal illness or severe medical illness: ASA score ≥3.
结局指标
主要结局
Neuromuscular control - Shouldersway
时间窗: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
- Shoulder sway. Measured as sway-length (in millimeter).
次要结局
- Apprehension measure(Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention)
- Neuromuscular control - Reaction Time(Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention)
- Clinical examination - Shoulder instability(Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention)
- Clinical examination - Shoulder range of motion(Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention)
- Strength measure(Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention)
- Redislocations(Will be tested 3, 6, 12 and 24 months after the beginning of the intervention)
- Neuromuscular control - Joint Position Sense(Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention)
- Patient-reported outcome measures(Will be tested prior to intervention and 3, 6, 12 and 24 months after the beginning of the intervention)
研究者
Kristine Rask Andreasen
MD
Hvidovre University Hospital