To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients
Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina
This study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL).
The purpose of this observational study is to assess the incidence of spasticity in a group of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it affects the QoL of these subjects.
연구 개요
상태
상세 설명
One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. It is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability.
The spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. It is a frequent cause for consultation among subjects with MS and, consequently, has a significant impact on the QoL. Men and those subjects with MS of longer duration are the most affected by spasticity.
The aim of this study is to assess the impact that spasticity has on the QoL of subjects with MS.
The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Rosario, 아르헨티나
- Fundacion Rosarina de Neurorehabilitacion
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Subjects aged from 21 60 years of age
- Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005
- Subjects with a diagnosis of RRMS for more than one year
- The subject who have signed the Informed Consent
Exclusion Criteria:
- Subjects with other causes of spasticity
- Subjects with other clinical forms of MS (different from relapsing-remitting)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Assess the prevalence of spasticity in subjects with RRMS
기간: Initial visit (Day 0) to 24 months
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Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36
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Initial visit (Day 0) to 24 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Evaluation of the impact of spasticity on the quality of life of subjects with RRMS
기간: Initial visit (Day 0) to 24 months
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Initial visit (Day 0) to 24 months
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Evaluation of the changes in spasticity after 24 months
기간: Initial visit (Day 0) to 24 months
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Initial visit (Day 0) to 24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dr. Jose A. Brizuela, Fundación Rosarina de Neurorehabilitación. Rosario, Argentina.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- EMR200077-507
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다발성 경화증, 재발 완화에 대한 임상 시험
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