- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01723046
Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke (ARTHE)
Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
연구 개요
상세 설명
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Lore Van de Perre, MSc
- 전화번호: +32 14 56 23 10
- 이메일: lore.van.de.perre@khk.be
연구 장소
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Antwepen
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Geel, Antwepen, 벨기에, 2440
- Thomas More Kempen
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연락하다:
- Lore Van de Perre, MSc
- 전화번호: +32 14 56 23 10
- 이메일: lore.van.de.perre@khk.be
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연락하다:
- Peter Karsmakers, PhD
- 전화번호: +32 14 56 23 10
- 이메일: peter.karsmakers@khk.be
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수석 연구원:
- Lore Van de Perre, MSc
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부수사관:
- Roy Sevit, MSc
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부수사관:
- Koen Janssens, MSc
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부수사관:
- Peter Karsmakers, PhD
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부수사관:
- Louis Peeraer, Prof.PhD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with stroke, more than three months post onset
- No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
- Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
- Able to sit on a chair with adequate trunk stability
- Able to follow verbal instructions
- Able to communicate verbal information to the researchers
Exclusion Criteria:
- Patients who are medically unstable
- Cognitive disorders impeding the intervention
- Visual disorders impeding the intervention
- Subluxation of the shoulder joint
- Pusher syndrome
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Training with the device
Training with new upper limb robot assisted therapy device
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During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
다른 이름들:
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간섭 없음: Control group
The control group is treated with conventional therapy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fugl-Meyer test upper limb section
기간: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Stroke specific, performance based impairment index.
Applied to determine disease severity and describe motor recovery.
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Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Medical research council score
기간: Change from baseline Medical research council score at 8 weeks and 12 weeks
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Muscle strength assessment
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Change from baseline Medical research council score at 8 weeks and 12 weeks
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Active range of motion of the elbow joint
기간: Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
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Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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Passive range of motion of the elbow joint
기간: Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
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Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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Modified Ashworth Scale
기간: Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
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Spasticity measurement
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Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
ABILHAND questionnaire
기간: Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Questionnaire-based assessment of manual ability
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Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Functional independence measure
기간: Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Assessment of physical and cognitive disability, focusing on the burden of care.
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Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Stroke impact scale
기간: Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Questionnaire evaluating how stroke has impacted the person's health and life.
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Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Intrinsic motivation inventory
기간: Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
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Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
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Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lore Van de Perre, MSc, Thomas More Kempen
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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 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. .