Evaluation of a Method to Support Unstable Shoulders by Means of a Textile Scapula Orthosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Range of motion of arm elevation
研究概览
简要总结
Shoulder instability due to muscle weakness is a common problem in disorders of the upper extremities. During arm motion, the scapula acts as a dynamic base for the humeral head. To safely move the shoulder with an exoskeleton for the upper extremities a textile orthosis was developed that stabilizes the scapula against the thorax. The support level of the orthosis is continuously manually adjustable. To test the feasibility of our design and to improve the functionality of the textile orthosis, it needs to be investigated how the orthosis acts on people affected by shoulder instability. The investigators seek to explore how people with shoulder instability respond to the orthosis, and how they may benefit from the orthosis function. Therefore, the range of motion of arm elevation will be compared in different conditions: (i) without any support, (ii) with the support of a trained therapist, and (iii) when the device is engaged at the individual's optimal support level. Additionally, pilot tests will be performed to fix different parameters in our study protocol, such as the the optimal orthosis stiffness level and the ideal number of movement repetitions.
详细描述
In this study, participants suffering from muscular weakness in the upper extremities, particularly the shoulder joint, will be recruited. A clear indicator for muscular weakness in the shoulder joint is a scapula alata (winging scapula). Hence, participants recruited for this study should present with a scapula alata and a limited RoM of at least one of their upper extremities.
This study is designed as a cross-over trial. Each participant will take part in an experimental session that will last approximately 2 hours. At the beginning of the experiment, the participant will be informed about the measurement and sign the informed consent sheet. Additional demographic data and level of ability will be collected in a questionnaire.
Before the measurements, participants will be fitted a textile scapula orthosis. The orthosis will be instrumented to quantify the amount of support the orthosis provides to the user. Therefore, an array of force sensors is mounted between the orthosis and the skin to measure the qualitative force distribution and its rate of change. To measure the absolute force applied to the plate, a load cell will be mounted on the orthosis fastening mechanism. All force data will be collected synchronously through a Micro-Controller board.
The participants will be equipped with reflective adhesive markers to define the reference points for the range of motion measurements, which will be done with a goniometer and photographic opto-electronic motion tracking.
Nine blocks of measurements will be conducted, lasting 5 minutes each. The remaining time in the study accounts for rest periods, the mounting and demounting of the orthosis, instructions and questionnaires. The first eight blocks will present the following treatment conditions in randomized order:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Diagnosed scapula alata (winging scapula)
- •Limited range of motion of at least one of the upper extremities.
- •Ability to elevate the arm at least 110° passively
- •Able to sit in a chair without additional support and without leaning on the back rest.
- •Exclusion Criteria
- •Frozen shoulder
- •Osteoporosis or arthrosis of the shoulder joint
- •Shoulder subluxation
- •Excessive spasticity of the affected arm
- •Skin ulcerations on the paretic arm or torso
- •Known risk for impingement
- •Orthopaedic, rheumatological or other disease restricting movements of the paretic arm
- •Pain or stiffness in the shoulder joint limiting their movement
- •Cardiopulmonary disease
- •Psychiatric disorders or severe cognitive impairments that limit their ability to understand the study instructions
排除标准
- 未提供
结局指标
主要结局
Range of motion of arm elevation
时间窗: Up to 2 hours per participant
The maximum angle of arm elevation in the 80 or 30 degree plane the participant can reach under the different study conditions
Motor control during functional task
时间窗: Up to 2 hours per participant
Assessment of kinematic variables such as movement smoothness during the functional task
Improvement of range of motion of arm elevation
时间窗: Up to 2 hours per participant
The relative or absolute improvement of arm elevation in the orthosis assistance condition when compared to the without assistance condition and/or the manual assistance condition
Range of motion of arm elevation for different force levels in the orthosis assistance condition
时间窗: Up to 2 hours per participant
Relative or absolute improvement in range of motion or range of motion of arm elevation for different force levels in the orthosis assistance condition
次要结局
- Threshold for Beneficiary or Responsiveness level(Up to 2 hours per participant)
- Perceived effort(Up to 2 hours per participant)
- Beneficiary or Responsiveness level(Up to 2 hours per participant)
- Motor control during arm elevation(Up to 2 hours per participant)
- Comfort(Up to 2 hours per participant)