- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07680049
The Mediating Role of Balance in the Relationship Between Fatigue and Fear of Falling in Individuals With Multiple Sclerosis
연구 개요
상세 설명
Multiple sclerosis (MS) is a chronic demyelinating and neurodegenerative disease of the central nervous system that frequently leads to fatigue, balance impairment, and fear of falling. These symptoms negatively affect mobility, independence, participation in daily activities, and quality of life. Fatigue is one of the most common and disabling symptoms in individuals with MS and may contribute to impaired balance and an increased risk of falls.
Fear of falling is highly prevalent in people with MS and is associated with reduced physical activity, activity avoidance, and functional decline. Balance impairment is another common manifestation of MS and may represent an important mechanism linking fatigue to fear of falling. However, although fatigue, balance, and fear of falling have been investigated separately, the mediating role of balance in the relationship between fatigue and fear of falling has not been sufficiently explored.
The aim of this cross-sectional observational study is to investigate whether balance mediates the relationship between fatigue and fear of falling in individuals with multiple sclerosis. Fatigue will be assessed using the Fatigue Severity Scale (FSS), balance performance will be evaluated using the Mini-Balance Evaluation Systems Test (Mini-BESTest), and fear of falling will be measured using the Falls Efficacy Scale-International (FES-I).
The findings of this study are expected to improve the understanding of the mechanisms underlying fear of falling in individuals with MS and provide evidence to support the development of rehabilitation programs targeting balance to reduce fear of falling and improve functional outcomes.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Uskudar
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Istanbul, Uskudar, 터키 (Türkiye), 34662
- Uskudar University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age 18-65 years
- Neurologist-confirmed MS diagnosis
- No relapse within the previous 30 days
- Ability to walk independently or with an assistive device
- Ability to understand instructions
- Voluntary participation
Exclusion Criteria:
- Recent MS relapse
- Severe vestibular disorder
- Other neurological diseases
- Severe orthopedic conditions affecting mobility
- Recent lower extremity surgery or trauma
- Cardiopulmonary conditions limiting assessment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Individuals with Multiple Sclerosis
Adults diagnosed with multiple sclerosis who meet the eligibility criteria will participate in a single assessment session to evaluate fatigue, balance, and fear of falling.
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Observational Model: Cross-Sectional
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Falls Efficacy Scale-International
기간: Time Frame: Baseline (single assessment)
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Fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I).
The FES-I is a 16-item questionnaire that evaluates concern about falling during a range of daily activities.
Total scores range from 16 to 64, with higher scores indicating greater fear of falling.
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Time Frame: Baseline (single assessment)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fatigue Severity Scale (FSS)
기간: Baseline (single assessment)
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Fatigue severity will be assessed using the Fatigue Severity Scale (FSS).
The FSS consists of 9 items rated on a 7-point Likert scale.
The total score is calculated as the mean of all items, with higher scores indicating greater fatigue severity.
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Baseline (single assessment)
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Baseline (single assessment)
기간: Baseline (single assessment)
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Balance performance will be evaluated using the Mini-Balance Evaluation Systems Test (Mini-BESTest).
The Mini-BESTest consists of 14 items assessing dynamic balance.
Total scores range from 0 to 28, with higher scores indicating better balance performance.
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Baseline (single assessment)
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. doi: 10.1191/1352458503ms904oa.
- Nilsagard Y, Lundholm C, Denison E, Gunnarsson LG. Predicting accidental falls in people with multiple sclerosis -- a longitudinal study. Clin Rehabil. 2009 Mar;23(3):259-69. doi: 10.1177/0269215508095087.
- Hebert JR, Corboy JR. The association between multiple sclerosis-related fatigue and balance as a function of central sensory integration. Gait Posture. 2013 May;38(1):37-42. doi: 10.1016/j.gaitpost.2012.10.015. Epub 2012 Nov 28.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- Uskudar-MS
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
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