Muscle Excitability Scale for Assessment of Spastic Reflexes in Spinal Cord Injury. Part II: Validity and Reliability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Muscle Excitability Scale
研究概览
简要总结
The aim of the study is to verify validity and reliability of the Muscle excitability scale (MES), which has been developed to access muscle susceptibility to spasms and/or clones as part of spastic motor behavior in spinal cord injured patients.
详细描述
The muscle excitability scale (MES) is intended for patients after spinal cord injury. The objective is to evaluate a motor response (muscle spasms or clones) to a sensory or motor stimulus. A sensory stimulus is created by thumb and pointfinger compression of cutaneous tissue on the inside part of the middle thigh and calf. A motor stimulus is created by passive movement of the lower limb to flexion and extension. The MES grades from 0 to 4 reflect the muscle spastic or clonic tendency and the extent of this motor response (from isolated to generalized). Two investigators will examine a spastic motor behavior in 50 chronic SCI subjects using MES, Modificated Ashworth Scale (MAS) and Penn Spasms Frequency Scale (PSFS) to verify the validity and reliability of the MES.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spasticity in Spinal Cord Injury
排除标准
- •Parallel brain injury
- •Cognitive deficit affecting cooperation
- •Acute infection or other sudden complication
- •Recent change of antispastic medication
结局指标
主要结局
Muscle Excitability Scale
时间窗: through study completion, an average of 1 year
Scoring from 0 to 4; 0 = no motor response (muscle spasm or clonus) to a tactile stimulus or passive movement; 4 = generalized motor response to both a tactile stimulus and passive movement
Penn Spasm Frequency Scale
时间窗: through study completion, an average of 1 year
Scoring 0 to 4; 0 = no spasms; 4 = spasms occurring more than 10 times per hour
Modified Ashworth Scale
时间窗: through study completion, an average of 1 year
Scoring from 0 to 4; 0 = no increase in muscle tone; 4 = affected part(s) rigid in flexion or extension
次要结局
- Calculation of validity and reliability index of Muscle Excitability Scale(through study completion, an average of 1 year)
研究者
Assoc. Prof. Jiri Kriz, MD, PhD
Clinical Professor
University Hospital, Motol