Encouragement-induced Movement Therapy in Daily Life (ISEAR)
Encouragement-induced Movement Therapy in Daily Life - a Randomized Controlled, Assessor-blinded Multi-center Trial in Stroke Patients With a Unilateral Hemiparesis, Using a Wrist-worn Tracking and Feedback Device
Stroke places a major burden on health care and society. It often leads to a hemiparesis. Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or human resources to provide this intensive rehabilitation are often lacking. Applying modern-day tracking and feedback technology to encourage a self-administered, context specific training is expected to offer significant potential to increase intensity of practice. Up until now, there has been no randomized trial examining the effect of such an intervention on daily arm usage.
The primary objective of this study is to determine the effect of wearing an activity tracking and multimodal feedback device for six weeks on self-reported daily life use of the paretic arm after stroke, when compared to control group stroke subjects wearing a hardware-wise identical sham device providing no feedback. The secondary aim is to examine compliance to use the device and the quantitative, qualitative and functional improvement of the paretic arm. It is hypothesized that participants in the experimental group show a higher change in self-reported daily life use of the paretic arm when compared to the control group both post intervention and at 6-week follow-up.
ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond the first 3 months poststroke.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Vitznau, 스위스
- Cereneo, Center For Neurology and Rehabilitation
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Wald, 스위스
- Zürcher RehaZentrum Wald
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Zürich, 스위스
- University Hospital Zurich
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Above 18 years of age with unilateral stroke and residual hemiparesis leading to a decrease of arm function after completion of all inpatient rehabilitation (at least 90 days post stroke)
- Ability to lift arm against gravity (>30 degrees flexion or abduction)
- Ability to don/doff the devices on both wrists independently or with assistance of a caregiver
- Ability to give informed consent as documented by signature
Exclusion Criteria:
- Major untreated depression
- Severe cognitive impairment
- Suffering from comprehensive aphasia
- Severely impaired sensation (unable to feel a soft touch on the dorsal side of their paretic wrist with closed eyes)
- Other major comorbidities (e.g., cardiopulmonary disease, renal failure, hepatic dysfunction, orthopedic disorders, etc.)
- Expected hospitalization during study period
- Known intolerance to device material
- Known or suspected non-compliance, drug or alcohol abuse
- The investigator, his/her family members, employees, and other dependent persons
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Monitoring and Feedback
Subjects will use two wrist-worn wearables over a period of 6 weeks.
Patients will receive multimodal (vibrotactile and visual) feedback.
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See arm/group description.
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위약 비교기: Monitoring
Study subjects will use identical devices over a period of 6 weeks.
Patients will *not* receive multimodal feedback.
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See arm/group description.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Motor Activity Log - 14, Amount of Use sub scale
기간: Post-intervention (6 weeks)
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Self-reported amount of upper limb use in daily life
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Post-intervention (6 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fugl-Meyer Assessment, Upper Extremity sub scale
기간: Post-intervention (6 weeks)
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Upper limb motor function
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Post-intervention (6 weeks)
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Fugl-Meyer Assessment, Upper Extremity sub scale
기간: Follow-up (12 weeks)
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Upper limb motor function
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Follow-up (12 weeks)
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Action Research Arm Test
기간: Post-intervention (6 weeks)
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Upper limb capacity
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Post-intervention (6 weeks)
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Action Research Arm Test
기간: Follow-up (12 weeks)
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Upper limb capacity
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Follow-up (12 weeks)
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Modified Rankin Scale
기간: Post-intervention (6 weeks)
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Global Disability
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Post-intervention (6 weeks)
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Modified Rankin Scale
기간: Follow-up (12 weeks)
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Global Disability
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Follow-up (12 weeks)
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EuroQol five dimensions five levels questionnaire
기간: Post-intervention (6 weeks)
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Quality of Life
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Post-intervention (6 weeks)
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EuroQol five dimensions five levels questionnaire
기간: Follow-up (12 weeks)
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Quality of Life
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Follow-up (12 weeks)
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Motor Activity Log - 14, Quality of Movement sub scale
기간: Post-intervention (6 weeks)
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Self-reported quality of upper limb use in daily life
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Post-intervention (6 weeks)
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Motor Activity Log - 14, Quality of Movement sub scale
기간: Follow-up (12 weeks)
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Self-reported quality of upper limb use in daily life
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Follow-up (12 weeks)
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Motor Activity Log - 14, Amount of Use sub scale
기간: Follow-up (12 weeks)
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Self-reported amount of upper limb use in daily life
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Follow-up (12 weeks)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Global Rating of Perceived Change
기간: Post-intervention (6 weeks)
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Post-intervention (6 weeks)
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Global Rating of Perceived Change
기간: Follow-up (12 weeks)
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Follow-up (12 weeks)
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Concomitant movement therapy
기간: Post-intervention (6 weeks)
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Time spend at Movement therapy (e.g., Physiotherapy, Occupational therapy)
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Post-intervention (6 weeks)
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Concomitant movement therapy
기간: Follow-up (12 weeks)
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Follow-up (12 weeks)
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Adverse Events
기간: Baseline (0 week)
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Safety
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Baseline (0 week)
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Adverse Events
기간: Post-intervention (6 weeks)
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Safety
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Post-intervention (6 weeks)
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Adverse Events
기간: Follow-up (12 weeks)
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Safety
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Follow-up (12 weeks)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Andreas R Luft, Prof. MD, University of Zurich
간행물 및 유용한 링크
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 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. .
뇌졸중에 대한 임상 시험
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Institut National de la Santé Et de la Recherche...모병
Wrist-worn wearables에 대한 임상 시험
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Milton S. Hershey Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)모병