Nutritional Status and Muscle Function in Ambulatory Multiple Sclerosis Patients With Dysphagia

NCT07564921 | Enrolling By Invitation

• 1 other identifier: hakanpolat18
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the relationship between dysphagia severity and indicators of nutritional status and muscle function in ambulatory patients diagnosed with Multiple Sclerosis (MS) who have swallowing difficulties. In patients with MS, the prevalence of swallowing disorders increases with disease duration and greater neurological involvement. Dysphagia may lead to important clinical consequences such as aspiration risk, inadequate oral intake, involuntary weight loss, and reduced quality of life. Swallowing difficulties negatively affect both the adequacy and safety of nutrition, thereby increasing the risk of malnutrition. In addition, reduced energy and protein intake may lead to a decline in muscle strength and functional capacity. However, in the MS population, dysphagia, nutritional status, and muscle function are often evaluated separately, and studies that assess these domains together are limited. There is a need for real-world data in ambulatory MS patients, particularly using age-independent nutritional screening tools and functional muscle assessment tests in combination. This study aims to systematically and multidisciplinary evaluate nutritional status and muscle function in MS patients with dysphagia.

Conditions

Multiple Sclerosis; Nutrition; Swallowing

Keywords

multiple sclerosis; nutrıtıon; swallowing

Outcome Measures

Primary Outcomes (5)

• Body weight and height

  These will be measured in accordance with standard anthropometric measurement protocols. Height will be measured using a stadiometer with participants standing in the Frankfurt plane. Body weight will be measured with a calibrated digital scale accurate to 0.1 kg. Body mass index (BMI) will be calculated by dividing body weight in kilograms by the square of height in meters.

  2 months

• Eating Assessment Tool-10 (EAT-10)

  Developed by Belafsky and colleagues , this is a 10-item self-report scale that assesses the severity of dysphagia as perceived by the patient. Each item is scored on a scale of 0-4, and the total score ranges from 0 to 40. A total score of 3 or higher indicates a clinically significant risk of dysphagia. The validity and reliability of the scale in Turkish were established by Demir and colleagues.

  2 months

• Dysphagia in Multiple Sclerosis (DYMUS)

  Dysphagia in Multiple Sclerosis (DYMUS): DYMUS is a 10-item self-administered questionnaire requiring "yes/no" responses, developed to assess symptoms and signs of swallowing difficulties specific to multiple sclerosis (MS) in relation to solid and liquid foods. The validity and reliability study of the Turkish version was conducted by Arslan and colleagues, and it has been demonstrated that the Turkish version is a valid and reliable tool for assessing dysphagia in patients with MS.

  2 months

• Yale Swallowing Protocol

  A standardized swallowing screening test developed to assess the risk of aspiration and the safety of oral feeding in individuals with swallowing disorders. The protocol focuses specifically on determining the risk of aspiration during fluid intake and is used as a quick and reliable screening tool in clinical practice. The test consists of a structured procedure requiring the individual to drink approximately 90 mL (3 ounces) of water without interruption.

  2 months

• Malnutrition Universal Screening Tool (MUST)

  MUST is a short, practical, and age-independent nutritional screening tool developed to identify the risk of malnutrition in adults. It consists of three components: Body Mass Index (BMI), unintentional weight loss in the past 3-6 months, and the impact of acute illness or inability to eat. Based on the total score, individuals are classified as having low, moderate, or high risk of malnutrition. British Association for Parenteral and Enteral.

  2 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

MS patients with swallowing difficulties

You may qualify if:

• Be 18 years of age or older
• Have a diagnosis of multiple sclerosis according to the 2017 Revised McDonald criteria
• Have difficulty swallowing (DYMUS \>1)
• EDSS score must be available in clinical records
• Possess sufficient cognitive and physical capacity to participate in the questionnaires and assessments to be administered as part of the study

You may not qualify if:

• \. A recent acute MS relapse or use of high-dose corticosteroids within the past 4 weeks 2. Acute orthopedic or traumatic conditions that prevent the performance of measurements 3. Severe cognitive impairment that prevents understanding or performing the tests 4. Being pregnant or breastfeeding 5. Presence of active malignancy or advanced systemic disease 6. Having any pathology in the cervical region

Sponsors & Collaborators

• Sanko University: lead

Study Sites (1)

Sanko Unıversıtesı

Gaziantep, şehitkamil, 27500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: February 1, 2026
• Primary Completion: April 15, 2026
• Study Completion: May 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

TU (1)