Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
2017년 5월 17일 업데이트: Chang Gung Memorial Hospital
Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program
The purpose of this study was to compare the treatment effects of home-based or clinic-based bilateral training with and without mirror feedback programon on physiological markers, sensorimotor, cognition, daily functions, and participation among patients with chronic stroke.
연구 개요
연구 유형
중재적
등록 (실제)
24
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Kaohsiung County, 대만
- Chang Gung Memorial Hospital
-
Taoyuan County, 대만
- Chang Gung Memorial Hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- The most recent stroke was between 1 month and 5 years
- No serious cognitive impairment (MMSE≥21)
- FMA score =18-62
- No serious muscle spasticity in shoulder, elbow, wrist and finger (MAS≤3)
- Modified rankin Scale=2 to 4
Exclusion Criteria:
- Aphasia that might interfere with understanding instructions
- Stroke in areas other than the brain and brainstem, such as the cerebellum
- other neurological disease, such as dementia
- Muscle and joint have serious pain and inflammatory swelling in affected side.
- Cannot control hypertension, heart disease and serious throbosis
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Home-based
Participants in home-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the home-based training, a four-week wash-out period followed. Then, patients will receive the clinic-based training for 4 continuous weeks. Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed. |
|
|
활성 비교기: Clinic-based
Participants in clinic-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the clinic-based training, a four-week wash-out period followed. Then, patients will receive the home-based training for 4 continuous weeks. Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Fugl-Myer Assessment, FMA
기간: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
|
Mini-Mental State Exam, MMSE
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
pinch and grasp dynamometer
기간: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
|
Modified Ashworth Scale, MAS
기간: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
|
Revised Nottingham Sensory Assessment
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
10-Meter Walking Test, 10MWT
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Box and Block Test, BBT
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Wolf Motor Function Test, WMFT
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Chedoke Arm and Hand Activity Inventory
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Canadian Occupational Performance Measure, COPM
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Nottingham Extended Activities of Daily Living, NEADL
기간: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
|
ABILHAND Questionnaire
기간: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
|
Motor Activity Log, MAL
기간: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
|
Actigraphy
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Stroke Impact Scale, SIS
기간: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
|
The World Health Organization Quality of Life -Brief version, WHOQOL-BRE
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Medical Research Council scale,MRC
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
6 minute walk test
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
The Euroqol Quality of Life Scale
기간: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
|
Lawton-Brody IADL Scale
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Pittsburg Sleep Quality Index
기간: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Montreal Cognitive Assessment, MoCA
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Minnesota Rate of Manipulation Test during dual Task
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Stroop Test
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Modified Rankin Scale, mRS
기간: baseline
|
baseline
|
|
30 second sit-to-stand test
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
Timed up and go test
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
The stroke self-efficacy questionnaire
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
|
BDI-II，Beck Depression Inventory II
기간: Change from baseline up to 4 weeks immediately after the completion of intervention
|
Change from baseline up to 4 weeks immediately after the completion of intervention
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 9월 1일
기본 완료 (실제)
2017년 4월 12일
연구 완료 (실제)
2017년 4월 12일
연구 등록 날짜
최초 제출
2015년 1월 14일
QC 기준을 충족하는 최초 제출
2015년 2월 10일
처음 게시됨 (추정)
2015년 2월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 5월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 17일
마지막으로 확인됨
2016년 11월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 103-3962A3
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. .
만성 뇌졸중에 대한 임상 시험
-
Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
-
Institut National de la Santé Et de la Recherche...모병