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临床试验/NCT05179473
NCT05179473招募中不适用

Changing Practice: Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients: a Pilot Study

McGill University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
1
主要终点
TSRT

研究概览

简要总结

Spasticity, or greater muscle resistance, is a major disabling condition following stroke. Recovery of lost motor function in patients with stroke may be affected by spasticity, which most commonly develops in elbow and ankle muscles. However, despite its clinical relevance, the natural development of spasticity over the first 3 months after stroke is not clearly understood. Indeed, common clinical measures of spasticity such as the Modified Ashworth Scale (MAS) do not take into account the neurophysiological origin of spasticity and lack reliability and objectivity.

The objective of this study is to examine the natural history of the development of spasticity among patients with stroke over the first 3 months using a new neurophysiological measure (TSRT, the tonic stretch reflex threshold angle) and its velocity sensitivity (mu) in comparison to MAS and other common clinical tests. In addition, detailed brain imaging will be used to understand the relationship between damage to brain regions relevant to the development of spasticity and TSRT/mu values.

It is hypothesized that 1) TSRT/mu will indicate the presence of spasticity earlier than MAS/clinical tests; 2) TSRT/mu measures will be more closely related to motor impairments and activity limitations than MAS; 3) the lesion severity (identified by imaging) will be related to the change in TSRT/mu values.

Outcomes will be measured in a pilot cohort of 12 patients hospitalized for first-ever stroke. Measurements will be taken at the bedside within the 1st week of the patient's admission and will be done once per week for 12 weeks with a follow-up at week 16. Brain Imaging will be done around the 6th week post-stroke.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute stroke in Middle Cerebral Artery area resulting in hemiparesis.
  • Hemorrhagic or ischemic
  • Medically stable
  • Able to provide informed consent

排除标准

  • Severe cognitive disorders

结局指标

主要结局

TSRT

时间窗: up to 16 weeks

Tonic stretch reflex threshold measured in the elbow flexors or ankle plantarflexors

Mu

时间窗: up to 16 weeks

Velocity sensitivity of the TSRT

Modified Ashworth Scale (MAS)

时间窗: up to 16 weeks

Measure of the increase of muscle resistance to stretch felt by examiner in the elbow flexors or ankle plantarflexors

Reflexes

时间窗: up to 16 weeks

Measured in the elbow flexors or ankle plantarflexors

次要结局

  • Berg Balance Scale(up to 16 weeks)
  • Box and Blocks Test (BBT)(up to 16 weeks)
  • Passive Range of Motion (PROM)(up to 16 weeks)
  • Semmes-Weinstein filaments(up to 16 weeks)
  • Fugl-Meyer Assessment Upper Limb/Lower Limb (FMA - UL/LL)(up to 16 weeks)
  • Timed Up and Go (TUG)(up to 16 weeks)
  • Active Range of Motion (AROM)(up to 16 weeks)
  • Maximal Voluntary Force (MVF)(up to 16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mindy F. Levin

Professor

McGill University

研究点 (1)

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