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临床试验/NCT07468110
NCT07468110招募中不适用

Evaluation Of The Relationship Between The Conut Score And Balance And Functional Status In Patients With Chronic Stroke

Marmara University1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2026年3月10日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
47
试验地点
1
主要终点
Berg Balance Scale

研究概览

简要总结

The primary aim of this study is to evaluate the relationship between the CONUT score, which reflects nutritional status, and balance performance in patients with chronic stroke. The secondary aims are to investigate the association between the CONUT score and functional status and stroke-specific quality of life, as well as to assess the relationships of mid-upper arm circumference, an anthropometric indicator of nutritional status, and ultrasonographic rectus femoris muscle thickness, which reflects muscle mass, with balance performance, functional status, and stroke-specific quality of life. In addition, the study aims to examine the relationships between bone mineral density and balance, functional status, and ambulation level in patients with chronic stroke.

详细描述

Stroke is a clinical syndrome characterized by rapidly developing neurological deficits resulting from the sudden interruption or reduction of cerebral blood flow and remains one of the leading causes of mortality and long-term disability among adults worldwide. Following the acute phase, a substantial proportion of patients transition to the chronic stage, during which persistent functional impairments such as motor deficits, balance disorders, gait limitations, and dependence in activities of daily living frequently occur.

During the post-stroke period, the risk of malnutrition increases due to factors such as dysphagia, immobility, reduced oral intake, increased catabolism, and muscle loss, all of which may negatively affect functional recovery and rehabilitation outcomes. In particular, deterioration of nutritional status in patients with chronic stroke has been reported to be associated with reduced muscle strength, impaired postural control, and increased dependence in activities of daily living.

Balance disorders in patients with chronic stroke are closely associated with reduced postural control, decreased muscle strength, and impaired sensorimotor integration. Impaired balance increases the risk of falls during the chronic phase of stroke, reduces walking speed, and limits functional independence. In addition, malnutrition characterized by decreased muscle mass and muscle function has been reported to have adverse effects on postural stability and balance performance. Therefore, evaluating the relationship between nutritional status and balance performance in patients with chronic stroke is of considerable importance for clinical management and rehabilitation strategies.

In the assessment of nutritional status, anthropometric measurements, in addition to biochemical markers, provide valuable information regarding muscle and fat tissue reserves. Mid-upper arm circumference is a simple and reliable anthropometric parameter reflecting muscle mass and peripheral tissue reserves, and it has been shown to be associated with nutritional status and functional outcomes in chronic diseases. Considering muscle loss related to immobility and asymmetric loading in stroke patients, the use of mid-upper arm circumference as a complementary indicator in evaluating the relationship between nutritional status and balance and functional status is clinically meaningful.

The Controlling Nutritional Status (CONUT) score, used to assess nutritional status, is an objective nutritional assessment index based on serum albumin level, total lymphocyte count, and total cholesterol concentration, reflecting not only nutritional status but also immunological and metabolic conditions. Although the CONUT score was initially developed for hospitalized patients, it has been shown to be associated with functional outcomes and mortality in patients with stroke. Evidence suggests that nutritional status may deteriorate from the acute phase through the chronic stage and remains clinically relevant even during the chronic phase of stroke.

研究设计

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

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

  • Being 18 years of age or older
  • Having a diagnosis of ischemic or hemorrhagic stroke
  • At least 6 months having elapsed since the stroke event (chronic phase)
  • Being clinically stable
  • Being able to participate in standing and balance assessments (walking with an assistive device is acceptable)
  • Having sufficient cognitive capacity to understand and respond to the assessment scales used in the study
  • Voluntarily agreeing to participate in the study and providing written informed consent

排除标准

  • Acute or subacute stroke phase (< 6 months)
  • Inability to administer assessment scales due to severe cognitive impairment or aphasia
  • Presence of other neurological disorders that may significantly affect balance and functional status (e.g., Parkinson's disease, multiple sclerosis, peripheral neuropathy)
  • Significant orthopedic conditions unrelated to stroke (e.g., advanced hip or knee osteoarthritis, lower extremity amputation)
  • Presence of active infection, malignancy, or systemic inflammatory disease (as these conditions may affect the CONUT score)
  • Cerebellar localization of the cerebrovascular event
  • History of major surgery or intensive care unit admission within the past 3 months
  • Inability to safely perform balance tests due to severe visual or hearing impairment
  • Patients with incomplete laboratory data or insufficient information to calculate the CONUT score

研究组 & 干预措施

Patients with chronic stroke

Patients followed up in our outpatient clinics due to chronic stroke

结局指标

主要结局

Berg Balance Scale

时间窗: At baseline

The Berg Balance Scale is a measure developed to assess individuals' balance performance and consists of 14 items that include activities of daily living. Each item is scored between 0 and 4, with the total score ranging from 0 to 56. Lower scores indicate poorer balance performance and an increased risk of falls.

次要结局

  • Tinetti Performance-Oriented Mobility Assessment(At baseline)
  • Stroke-Specific Quality of Life Scale (SS-QOL)(At baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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