Clinical trial NCT03878836: Follow-up of Persons With Multiple Sclerosis
Official title: Follow-up of Physical, Psychosocial and Cognitive Influences in Persons With Multiple Sclerosis: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with multiple sclerosis

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple sclerosis
* Willingness to participate

Exclusion Criteria:

* Severe cognitive, physical, or psychiatric disability that prevent the assessments

Primary outcomes:
measure: Expanded Disability Status Scale
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary outcomes:
measure: Timed 25-Foot Walk
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Timed Up and Go test
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Single Leg Stance Test
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: 6-Minute Walk Test
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: 12-Item Multiple sclerosis walking scale
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Modified Fatigue Impact Scale
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Epworth Sleepiness Scale
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Symbol Digit Modalities Test
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: California Verbal Learning Test-II
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Revised Brief Visuospatial Memory Test
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Godin Leisure Time Exercise Questionnaire
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Multiple Sclerosis International Quality of Life questionnaire
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Beck Depression Inventory
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Nine-Hole Peg Test
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: Nordic Musculoskeletal Questionnaire
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: painDETECT Questionnaire
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
measure: International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
timeFrame: Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Hospital, MS Outpatient Clinic
Study officials:
affiliation: Dokuz Eylul University
name: Serkan Ozakbas, MD
role: PRINCIPAL_INVESTIGATOR
References: