跳至主要内容
临床试验/NCT06381999
NCT06381999已完成不适用

Initial Assessment of the Validity and Inter-Rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool

Merz Therapeutics GmbH2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral

研究概览

简要总结

The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool.

详细描述

The Spastic Movement Disorder (SMD) Decision Tree was designed as a tool to aid nurses, therapists and other healthcare professions recognize potential signs of disabling spasticity in the upper limb of post-stroke patients. The present study assesses validity and inter-rater reliability of the SMD Decision Tree comparing nurses and therapists with gold-standard procedure performed by rehabilitation doctors. Agreement was tested for "referral to specialist indicated" and "no referral to specialist indicated".

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with a first sub-acute and chronic infarction of the middle cerebral artery / basal ganglia hemorrhage longer than four weeks after the event
  • Between 18-80 years old
  • Preserved insight and judgment capacity
  • Adequate language and task comprehension, attention span for 15 minutes

排除标准

  • Participants with other neurological disorders
  • Participants who received BoNT-A treatment < 3 months before inclusion
  • Reduced vigilance and attention span (less than 15 minutes)
  • Participants with adult representation
  • Participants with severe language impairment / impairment of movement and action sequences

结局指标

主要结局

Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral

时间窗: Day 1-2

Nurses use the 3 domains of the SMD Decision Tree (passive/active movement, pain) to determine potential disabling spasticity indicated for referral to a rehabilitation specialist. Specialized physicians use standard clinical procedure to detect disabling spasticity.

次要结局

  • Assessment of the level of agreement between the physiotherapist and/or occupational therapist group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral(Day 1-2)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验