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临床试验/NCT04613661
NCT04613661已完成不适用

Inter-rater Reliability of the Australian Spasticity Assessment Scale (ASAS) in Post-stroke Spasticity

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2020年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
Australian Spasticity Assessment Scale (ASAS)

研究概览

简要总结

The reliability of the Australian Spasticity Assessment Scale (ASAS) has been reported to be not high enough in adult patients with acquired brain damage. The low number of patients and the heterogeneous study population have been reported as important limitations in the reliability study of this measure. Therefore, the reliability of the ASAS needs to be confirmed in stroke patients with spasticity. This study aims to investigate the inter-rater reliability of the ASAS in a study population consisting of a larger and more homogeneous patient population (those with post-stroke spasticity).

详细描述

Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex due to upper motor neuron lesion. The prevalence of post-stroke spasticity is between 17-40%. In the assessment of spasticity, although biomechanical and neurophysiological methods provide quantitative data, semi-quantitative methods are mostly used clinically. The most frequently used spasticity measures are the Modified Ashworth Scale and the Modified Tardieu Scale. However, these methods have significant disadvantages. Therefore, the search for more reliable clinical measures continues. One of the newly developed clinical scales is called the Australian Spasticity Assessment Scale (ASAS). Although ASAS has been reported to have a high level of reliability in children with cerebral palsy, the same has not been detected in adult patients with acquired brain damage. The low number of patients and the heterogeneous study population have been reported as two of the important limitations in the reliability study of this measure.

In this study, researchers aim to investigate the inter-rater reliability of the ASAS in a study population consisting of a larger and more homogeneous patient population (those with post-stroke spasticity).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic stroke (> 6 months)
  • Fist stroke
  • Increased tone according to the Modified Ashworth Scale in at least one of the elbow, wrist, and ankle
  • Stability of spasticity for the last 3 months

排除标准

  • Increased tone due to causes other than stroke (traumatic brain injury, spinal cord injury, multiple sclerosis, motor neuron disease, etc.)
  • Acute or subacute stroke (≤6 months)
  • Recurrent stroke attacks
  • Presence of contracture and/or moderate to severe pain in the joints to be assessed (elbow, wrist, and ankle)
  • Botulinum toxin injection in the last three months
  • History of neurolysis for spasticity (alcohol or phenol)
  • History of surgery for spasticity
  • Initiation of a new drug for spasticity, or a change in drug dose

结局指标

主要结局

Australian Spasticity Assessment Scale (ASAS)

时间窗: Through study completion, an average of 2 year

The ASAS is an ordinal scale with five levels (0, 1, 2, 3, 4). The severity of spasticity increases as the level-ups.The contracture is assessed separately. Level 0 means no catch on rapid passive stretch (no spasticity), and level 4 means that the body part is fixed on the rapid passive stretch but moves on the slow passive stretch. In level 1, a catch followed by a release occurs on the rapid passive stretch. In level 2, the catch is in the second half of the range, and there is a resistance in the remaining range of motion. In level 3, the catch is in the first half of the range, and there is a resistance in the remaining range of motion.

次要结局

未报告次要终点

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ilker şengül

Principal Investigator

Izmir Katip Celebi University

研究点 (1)

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