- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07564921
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
-
-
şehitkamil
-
Gaziantep, şehitkamil, 터키 (Türkiye), 27500
- Sanko Unıversıtesı
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body weight and height
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- hakanpolat18
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .