- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02650960
Life Balance and Bimanual Activities After Stroke
The Flemish version of the Life Balance Inventory (LBI), measuring central constructs of life balance, will be validated in a stroke population. Upon approval by the ethical committee, stroke patients will be recruited when they are at least six months post stroke (n = 30). The LBI will be administered twice with one week interval, and demographic, socio-economic variables and other measures of health related quality of life will be collected.
Next, an observational prospective longitudinal study will be set up. We will recruit stroke patients in three rehabilitation centers within one week after admission in the rehabilitation center. Patients will undergo a baseline evaluation and will be re-assessed at discharge from the rehabilitation center, at six months and at 12 months post stroke. A standardized clinical assessment battery, measuring motor, sensory, cognitive, mental and functional outcomes as well as personal and environmental factors will be administered. This observational study will explore recovery patterns of bimanual activities after stroke from baseline evaluation to six and 12 months after stroke. Also the predictive value of motor, sensory, cognitive and mental outcomes on bimanual activities at six and 12 months post stroke is studied, based on data collected on admission to the rehabilitation center. Finally, changes over time in life balance and its determinants will be examined at six and 12 months post stroke. The predictive value of motor, cognitive and functional outcomes on life balance at one year post stroke will be examined, based on data collected on admission to the rehabilitation center. Furthermore the influence of bimanual activities on life balance will be explored in the chronic stage after stroke.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Antwerp, 벨기에
- RevArte
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Herk-de-Stad, 벨기에
- Jessa Hospitals
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Leuven, 벨기에
- UZ Leuven
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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:
- first-ever stroke, as defined by the WHO criteria
- assessed and included within the first week after admission in the rehabilitation center and within the first six weeks after stroke onset
- unilateral motor impairment in the upper limb (UL - Fügl-Meyer score ≤ 60)
- minimally 18 years old
- substantial cooperation to perform the assessments
- written informed consent
Exclusion Criteria:
- other neurological impairments with permanent damage such as multiple sclerosis or Parkinson's disease
- a subdural hematoma, tumor, encephalitis or trauma that lead to similar symptoms as a stroke
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Adult Assisting Hand Assessment - Stroke
기간: 12 months post stroke
|
observation based performance assessment
|
12 months post stroke
|
Life Balance Inventory
기간: 12 months post stroke
|
questionnaire
|
12 months post stroke
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Geert Verheyden, KU Leuven
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .