Follow-up of Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Follow-up of Physical, Psychosocial and Cognitive Influences in Persons With Multiple Sclerosis: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03878836
• Other study ID #: 2959-GOA
• Status: Recruiting
• Start date: October 1, 2016
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2019
• Source: Dokuz Eylul University
• Contact: Serkan Ozakbas, MD
• Phone: +902324124064
• Email: serkan.ozakbas[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of multiple sclerosis

• Willingness to participate

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Routine assessments
Routine assessments, no specific intervention

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University Hospital, MS Outpatient Clinic	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expanded Disability Status Scale	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.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Timed 25-Foot Walk	The Timed 25-Foot Walk is a quantitative mobility and leg function performance test based on a timed 25-walk. he patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score is the average of the two completed trials. Higher time represents slower walking speed and more walking impairment.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Timed Up and Go test	The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. The time is calculated from the initiation of the instruction to start and ends when the patient has sit down. Higher time represents more static and dynamic balance and mobility impairment.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Single Leg Stance Test	Single Leg Stance Test measures static balance while standing on a single leg with eyes open and closed. The patient is instructed to remain his/her stability during 60 seconds. The time is recorded while the patient loses his/her stability. The higher time represents better static balance.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	6-Minute Walk Test	The 6-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The goal is for the individual to walk as far and fast as possible in 6 minutes. The total distance is recorded. Higher distance represents a better submaximal exercise capacity.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	12-Item Multiple sclerosis walking scale	The 12-Item Multiple sclerosis walking scale is a self-assessment scale which measures the impact of multiple sclerosis on walking. It consists of 12 questions with Likert-type choose options concerning the limitations to walking due to multiple sclerosis during the past 2 weeks. Total score ranges 0 from 100. Higher scores indicate more impact of multiple sclerosis on walking.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Modified Fatigue Impact Scale	The Modified Fatigue Impact Scale provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The scale consists of 21 items with a Likert-type choose options. The total score for the scale is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. The total score ranges from 0 to 84. Higher score indicates higher level of fatigue.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Epworth Sleepiness Scale	The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Symbol Digit Modalities Test	The Symbol Digit Modalities Test is used to assess mental processing speed. Higher scores indicate better mental processing speed.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	California Verbal Learning Test-II	The California Verbal Learning Test-II is used to assess verbal memory. Higher scores indicate better verbal memory.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Revised Brief Visuospatial Memory Test	The Revised Brief Visuospatial Memory Test is used to assess visuospatial memory. Higher scores indicate better visuospatial memory.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Godin Leisure Time Exercise Questionnaire	The Godin Leisure Time Exercise Questionnaire is a commonly used questionnaire to measure of usual physical activity in persons with multiple sclerosis. It contains three items that measure the frequency of strenuous, moderate, and mild physical activities for periods of more than 15 minutes during one's free time within a typical week. Weekly frequencies of strenuous, moderate and mild physical activity were multiplied by 9, 5 and 3 metabolic equivalents, respectively, and were summed to form a measure of the total leisure physical activity. Scores range from 0 to 864 (hypothetically). Higher scores indicate higher level of physical activity. Participants with 24 units or more are considired as active, 14 - 23 units as Moderately Active, and Less than 14 units as Insufficiently Active/Sedentary.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Multiple Sclerosis International Quality of Life questionnaire	The Multiple Sclerosis International Quality of Life questionnaire is a disease-specific, self-administered, multidimensional questionnaire, was co-developed and initially validated in 15 countries including Turkey. The questionnaire comprises 31 questions in 9 subscales: activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, sentimental and sexual life, coping, rejection, and relationships with healthcare system. All 9 dimensions and the index score were linearly transformed and standardized on a 0-100 scale, where 0 indicates the worst possible level of quality of life and 100 indicates the best level.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Beck Depression Inventory	The Beck Depression Inventory is a widely used 21-items self-reported measure that assesses the presence and intensity of depressive symptoms reflecting the similar symptoms. Each question has a set of at least four possible answer choices, ranging in intensity. Higher scores indicate higher depressive symptoms. The scores range from 0 to 63.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Nine-Hole Peg Test	The Nine-Hole Peg Test is used to assess manual dexterity performance. It requires participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible. Two trials for each hand are performed and the score is the average time. Higher scores indicate less manual dexterity performance.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	Nordic Musculoskeletal Questionnaire	The Nordic Musculoskeletal Questionnaire includes 27 items exploring the presence of musculoskeletal symptoms during a 12-month period covering the nine different parts of the body. It also has items pertaining to severity grades, determined according to functional status and the presence of musculoskeletal symptoms during the last 7 days. All answers are given according to a dichotomous 'yes/no' response.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	painDETECT Questionnaire	The painDETECT Questionnaire is used to detect neuropathic pain components.The questionnaire consists of seven questions that address the quality of neuropathic pain symptoms; it is completed by the patient and no physical examination is required. The first five questions ask about the gradation of pain, scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5). Question 6 asks about the pain course pattern, scored from -1 to 2, depending on which pain course pattern diagram is selected. Question 7 asks about radiating pain, answered as yes or no, and scored as 2 or 0 respectively. The final score between -1 and 38, indicates the likelihood of a neuropathic pain component. A score of <=12 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of >= 19 suggests that pain is likely to have a neuropathic component (> 90%).	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months
Secondary	International Restless Legs Syndrome Study Group rating scale for restless legs syndrome	The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items. Higher scores indicate higher severity. The scores range from 0 to 40.	Change from Baseline at 6 Months, 18 Months, 30 Months, 42 Months, and 54 Months