ASSOCIATION BETWEEN PERIPHERAL IMMUNE BIOMARKERS AND FUNCTIONAL PERFORMANCE IN PATIENTS WITH MULTIPLE SCLEROSIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Multiple Sclerosis Functional Composite (MSFC)
研究概览
简要总结
The aim of this observational study is to investigate whether certain substances in the blood associated with the immune system are linked to the physical and mental abilities of individuals with multiple sclerosis. The study will examine the relationship of these substances with walking, hand coordination, cognitive skills, and functional loss resulting from the disease. Blood samples will be collected from participants, and simple tests assessing walking, hand coordination, and cognitive skills will be administered.
详细描述
This is an observational, cross-sectional study investigating the relationship between peripheral immune biomarkers and functional performance in patients with multiple sclerosis (MS). The study is designed to determine whether selected peripheral immune biomarkers are associated with functional performance and disability-related measures in individuals with MS.
Participants with a diagnosis of multiple sclerosis will be evaluated using clinical, demographic, functional, and laboratory measurements. The study includes 20 patients with multiple sclerosis. Data were collected between June 1, 2026 and July 30, 2026. All assessments were performed using baseline data, and no therapeutic or exercise intervention was administered as part of this study.
Peripheral immune biomarkers evaluated in the study include tumor necrosis factor-alpha (TNF-α), interleukin-8 (IL-8/CXCL8), and adiponectin. These biomarkers will be examined in relation to measures of functional performance.
Functional performance will be assessed using the Multiple Sclerosis Functional Composite (MSFC) and its components, including the Timed 25-Foot Walk test, the Nine-Hole Peg Test, and the Paced Auditory Serial Addition Test (PASAT). The results of the individual MSFC components will also be evaluated separately. Disability status will be assessed using the Expanded Disability Status Scale (EDSS).
Demographic and clinical characteristics, including age, sex, body mass index, and disease duration, will also be recorded. These characteristics will be considered when describing the study population and evaluating the relationship between immune biomarkers and functional performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS patients aged 19-45 who have been diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS), are not receiving steroid therapy, and have an Expanded Disability Status Scale (EDSS) score of 0.5-3.5.
排除标准
- •Those with a high level of physical activity; those experiencing an acute MS relapse or with a history of relapse within the last 3 months; those with orthopedic or systemic problems preventing participation in exercise; those with a known neuromuscular or immune disorder other than MS; those who started immunomodulatory therapy within the last 6 months; those with visual involvement or diplopia; those with severe lower-extremity spasticity (Modified Ashworth Scale score of 3 or 4); those with cardiopulmonary problems preventing participation in exercise.
研究组 & 干预措施
Multiple sclerosis participants
Participants with multiple sclerosis who were evaluated to examine the relationship between peripheral immune biomarkers and functional performance.
干预措施: Peripheral Immune Biomarkers (Other)
结局指标
主要结局
Multiple Sclerosis Functional Composite (MSFC)
时间窗: At baseline (study enrollment)
The Multiple Sclerosis Functional Composite (MSFC) is a standardized measure of functional performance in people with multiple sclerosis. It includes walking ability, hand coordination, and cognitive processing speed.
次要结局
未报告次要终点
研究者
Berna Calp
Physiotherapist
Halic University