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临床试验/NCT06589297
NCT06589297招募中不适用

Prognostic Value for Predicting Functional Outcome Bioimpedancemetry and Temporal Muscle Measurement in Acute Stroke

Centre Hospitalier Régional d'Orléans1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
phase angle

研究概览

简要总结

Body composition appears to be a prognostic factor for the severity and functional outcome of stroke patients. In this study the prognostic value of two bioimpedance parameters will be studied (skeletal mass index and phase angle) and two temporal muscle measurements (thickness and surface area) to predict the functional outcome of patients at discharge and at 6 months

详细描述

A stroke commonly causes weakness and loss of independence. Predicting functional outcomes is a major challenge because it guides rehabilitation care or institutionalization choices. Various factors, including the extent of the initial deficit or the size of the lesion, have been shown to play a role in residual disability after stroke. Premorbid physiological status has been less studied in stroke. However, loss of muscle mass and premorbid strength are prognostic factors for poor short- and medium-term functional recovery.

In this work, the body composition of patients in the acute phase of a stroke will be studied to determine whether its alteration is a poor prognostic factor in the short term (discharge from the initial hospitalization) and in the medium term (follow-up visit at 6 months). It will be studied using impedance analysis and morphological measurements on the temporal muscle.

In a cohort study of hospitalized patients in the acute phase of a stroke, measurements using a bioimpedance meter (InBody BWA) will be performed to measure a skeletal mass index (SMI) and phase angle. The properties of the temporal muscle (thickness and surface) will also be measured at T1, within 72 first hours after the stroke. Clinical and morphological data will also be collected (weight, height, initial deficit, lesion volume).

The aim of the work is to determine whether these body composition factors have an impact on the functional outcome of patients assessed at discharge and 6 months later. Functional assessment will be performed with modified Rankin score (mRS).

It is hypothesized that all body composition factors studied will be factors independent of the short- and medium-term functional prognosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • volunteer stroke patients in acute phase
  • Age ≥ 18 years
  • Having had a brain MRI
  • Able to understand assessment guidelines
  • Not having objected to participate in the study after being duly informed

排除标准

  • Person under tutorship or curatorship
  • Person under court protection
  • Persons deprived of their liberty
  • Pregnant or breastfeeding women
  • Have a pacemaker or defibrillator

研究组 & 干预措施

Acute stroke patients

Other

Acute stroke patients

干预措施: Modified Rankin scale (Diagnostic Test)

结局指标

主要结局

phase angle

时间窗: 72 hours after stroke

thickness of temporal muscle

时间窗: 72 hours after stroke

surface area of temporal muscle

时间窗: 72 hours after stroke

次要结局

  • Modified Rankin Scale (mRS)(Through month 3)
  • skeletal muscular Index(72 hours after stroke)
  • Modified Rankin Scale (mRS)(Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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