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

27 april 2026 bijgewerkt door: Hakan Polat, Sanko University

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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

34

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

MS patients with swallowing difficulties

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body weight and height
Tijdsspanne: 2 months
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)
Tijdsspanne: 2 months
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)
Tijdsspanne: 2 months
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
Tijdsspanne: 2 months
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)
Tijdsspanne: 2 months
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2026

Primaire voltooiing (Werkelijk)

15 april 2026

Studie voltooiing (Geschat)

1 mei 2026

Studieregistratiedata

Eerst ingediend

27 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2026

Eerst geplaatst (Werkelijk)

4 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

27 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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