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临床试验/NCT05456646
NCT05456646Enrolling By Invitation不适用

The Change in Temporal Muscle Thickness and Its Relationship With Sarcopenia and Functional Outcomes in Stroke Patients.

Bozyaka Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
150
试验地点
1
主要终点
Functional Ambulation Scale

研究概览

简要总结

This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change.

详细描述

It is well known that stroke increases the risk of developing sarcopenia . In addition, prestroke sarcopenia is associated with worse functional outcomes in patients with stroke. Temporal muscle thickness (TMT) has recently been proposed as a new marker of whole-body muscle mass and function. Measurement of temporal muscle mass by computed tomography (CT) and magnetic resonance imaging (MRI) has been studied in the literature in recent years. All stroke patients undergo cranial CT or MRI examinations at the time of admission. By evaluating the temporal muscle mass of these patients with these examinations, information about pre-stroke muscle mass and sarcopenia can be obtained. Ultrasonography (USG), on the other hand, may be a more accessible, less expensive, and safer option for assessing muscle mass in the follow-up of stroke patients. This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change by MRI/CT at admission and by USG in the chronic period.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of stroke
  • Presence of cranial MRI/CT in hospital records

排除标准

  • Medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation).
  • Severe cognitive impairment
  • Patients who require intensive care unit.

结局指标

主要结局

Functional Ambulation Scale

时间窗: 6. month

This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory).

Modified Rankin Scale (mRS)

时间窗: 6. month

It categorizes poststroke disability into six levels ranging from 0 to 5, with absence of symptoms rated as 0 and severe disability or bedriddenness rated as 5. An mRS score of 2 or less was defined as a good outcome, and an mRS score above 2 was defined as a poor outcome.

Functional Oral Intake Scale

时间窗: 6. month

The scale is rated with values between 1 and 7. Level 1-3 refers to tube-dependent feeding, level 4-6 to full oral feeding with restrictions, and level 7 to oral feeding without restrictions.

Dual energy X-ray absorptiometry (DEXA)

时间窗: 6.month

DEXA can be used to determine lean body mass and total body fat. The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.

Bioelectrical impedance analysis (BIA)

时间窗: 6.month

Body water mass, total body fat, and muscle mass can be determined with BIA.The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.

The Functional Independence Measure (FIM)

时间窗: 6.month

FIM is a scale that assesses 18 activities, including self-care, sphincter control, transfer, movement, communication, and social awareness. Total scores range from 18 to 126 (dependent in all domains - independent in all domains).

Handgrip strength

时间窗: 6. month

With the JAMAR Hand Dynamometer, 3 measurements will be taken for both hands 60 seconds apart in the standard position and the highest reading will be recorded.

次要结局

未报告次要终点

研究者

发起方
Bozyaka Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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