Follow-up of Physical, Psychosocial and Cognitive Influences in Persons With Multiple Sclerosis: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Expanded Disability Status Scale
研究概览
简要总结
Multiple sclerosis (MS) is a chronic, progressive and demyelinating disease that affects more than 2.5 million people in the world and is frequently seen in young adults between 20 and 40 years of age, especially in women. Although the exact MS in Turkey is not known, it is estimated as 40/100,000. According to epidemiological studies in recent years, the prevalence and incidence of MS tend to increase. The most common clinical signs and symptoms include loss of sensation in the extremities, partial or total vision loss, acute or subacute motor dysfunction, cognitive impairment, double vision and gait dysfunction.
Currently, MS has no definitive cure. Progressive symptoms related to the disease need to be managed in order to increase and maintain the quality of life of individuals with MS. Pharmacological, physiotherapeutic and psychotherapeutic methods are the most effective effective methods in the management of symptoms. However, the efficacy of these methods has been demonstrated in clinical trials. The outcomes cannot be generalized to the entire MS population because of the inclusion and exclusion criteria that exist in clinical trials. In addition, clinical trials are conducted at a specified time interval (usually a short time interval is selected) and generally, short-term results are provided. In order to better understanding the course of MS, it is of utmost importance that long-term follow-up studies are carried out where as many patients are included and patients are followed from the date of initial diagnosis. The aim of this study is to investigate the change of physical, psychosocial and cognitive characteristics over time and the correlated variables.
The volunteers from MS patients who attend routine control of the MS outpatient clinic of Dokuz Eylül University Hospital will participate in the study. Physical and clinical assessments will be performed by physicians and physiotherapists, and cognitive evaluations will be performed by psychologists with 6-month intervals.
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
- 否
入选标准
- •Diagnosis of multiple sclerosis
- •Willingness to participate
排除标准
- •Severe cognitive, physical, or psychiatric disability that prevent the assessments
结局指标
主要结局
Expanded Disability Status Scale
时间窗: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale is based on a neurological examination by a clinician. It has steps from 0 to 10. The higher scores indicate higher neurological disability.
次要结局
- 12-Item Multiple sclerosis walking scale(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Revised Brief Visuospatial Memory Test(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Timed 25-Foot Walk(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Single Leg Stance Test(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- California Verbal Learning Test-II(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Beck Depression Inventory(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Epworth Sleepiness Scale(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Symbol Digit Modalities Test(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Nordic Musculoskeletal Questionnaire(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Timed Up and Go test(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- 6-Minute Walk Test(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Godin Leisure Time Exercise Questionnaire(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Modified Fatigue Impact Scale(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Nine-Hole Peg Test(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- Multiple Sclerosis International Quality of Life questionnaire(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- painDETECT Questionnaire(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
- International Restless Legs Syndrome Study Group rating scale for restless legs syndrome(Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months)
研究者
Serkan Ozakbas
Principal Investigator
Dokuz Eylul University