Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in resistance to elbow extension measured using the portable spasticity assessment device (PSAD)
研究概览
简要总结
This project will determine the feasibility and validity of measuring elbow muscle flexor stiffness in a population of patients with sub-acute severe acquired brain injury using two measurement methods, the portable spasticity assessment device (PSAD) (Movotec, Charlottenlund, Denmark) and an ultrasound measurement called shear wave sonoelastography (SWE).
详细描述
The purpose of this study is to investigate the feasibility and validity of measuring hypertonia in the elbow flexors of patients with severe acquired brain injury in their sub-acute rehabilitation and collect data to determine the necessary size for a definitive study to determine the clinimetrics of the test methods. The long-term goal is to establish a valid and clinically feasible method for physiotherapists to quantify muscle tone in patients with neurological disorders.
The study hypotheses are:
- SWE, PSAD and Modified Ashworth Scale (MAS) measurements can be obtained for elbow flexion hypertonia in all patients (no missing data due to test procedure),
- SWE and PSAD have a moderate to good intra-day intra-tester reliability (ICC two-way mixed effects model with absolute agreement. ICC>0.5, Bland Altman)
- Passive muscle stiffness measured using the PSAD and SWE have a fair concurrent validity with MAS (Spearmans correlation >0.3)
- SWE and PSAD are responsive in measuring a reduction of the effect of routine clinical treatment of the hypertonic muscles with botulinum toxin type A (BTX-A) (paired T-test or Wilcoxon test, p>0.05)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention
The Group of patients will receive routine treatment of muscle hypertonia with botulinum toxin type A in their elbow flexors.
干预措施: Botulinum toxin type A injection (Drug)
结局指标
主要结局
Change in resistance to elbow extension measured using the portable spasticity assessment device (PSAD)
时间窗: Twice at baseline and 4 weeks post BoNT-A injection
The patient will be measured bilaterally using a PSAD.The PSAD utilises a load cell, gyroscopes and accelerometers and electromyography (EMG) and can measure full passive joint torque and joint angle together with corresponding muscle activity. A reduced passive moment in Nm when moving the joint indicates a reduced tissue stiffness.
Change in muscle stiffness in the treated muscle(s) measured using the shear wave elastography (SWE)
时间窗: Twice at baseline and 4 weeks post BoNT-A injection
The patient will be scanned using an ultrasound scanner with shear wave elastography in the treated muscle and the contralateral equivalent. A reduced speed of propgation of the shear waves in m per second indicates a reduced stiffness/tone in the muscle.
次要结局
- Muscle tone measured using modified ashworth scale(Baseline and 4 weeks post BoNT-A injection)
- Passive range of motion(Baseline and 4 weeks post BoNT-A injection)
研究者
Derek Curtis
Post doctoral fellow
Rigshospitalet, Denmark