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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis; Nutrition; Swallowing

Detailed Description

This study is a cross-sectional observational research conducted in ambulatory patients diagnosed with Multiple Sclerosis (MS) who experience swallowing difficulties. Participants who meet the inclusion criteria will be informed about the study, and written informed consent will be obtained prior to enrollment.

Demographic and clinical data of the participants (such as age, gender, and disease duration) will be recorded. Swallowing function will be assessed using validated dysphagia screening and/or assessment tools.

Nutritional status will be evaluated using standardized nutritional screening tools and/or anthropometric measurements (such as body weight, height, and body mass index). Muscle function will be assessed using functional measures, including handgrip strength and/or other appropriate muscle performance tests.

The collected data will be statistically analyzed to investigate the relationship between dysphagia severity, nutritional status, and muscle function. No invasive procedures will be performed in this study; only observational and measurement-based assessments will be conducted.

• Study Type: Observational
• Enrollment (Estimated): 34

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • şehitkamil
    • Gaziantep, şehitkamil, Turkey (Türkiye), 27500
      • Sanko Unıversıtesı

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

MS patients with swallowing difficulties

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 1. 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanko University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Actual): April 15, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: multiple sclerosis; swallowing; nutrıtıon
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: hakanpolat18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No