Effectiveness of Interactive Augmented Reality and Electrical Neuromodulation System in Persons With Stroke
2019년 12월 10일 업데이트: Lai chien hung, Taipei Medical University Hospital
Development of Interactive Augmented Reality and Electrical Neuromodulation System to Improve Neuroplasticity and Limbs Function in Persons With Stroke
This study is to investigate the effects of Augmented Reality (AR) combined with Functional Electrical Stimulation (FES) intervention on cortical excitability, brain structure, lower limbs function, balance, and spasticity in individuals with stroke.
Twenty participants will be recruited in this study.
They will be allocated to two group: AR and FES group (10), Traditional physiotherapy group (10).
연구 개요
상태
알려지지 않은
정황
상세 설명
Participants will be randomized allocated to two groups: Augmented Reality and Functional Electrical Stimulation group , and traditional physiotherapy group.
All participants will undergo 60 minutes per session, 3 sessions per week for 8 weeks training.
Functional Magnetic Resonance Imaging (fMRI) with Diffusion Tensor Imaging (DTI), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), 10 meter walking test will be assessed before and after intervention in all participants.
연구 유형
중재적
등록 (예상)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Taipei, 대만
- 모병
- Taipei Medical University Hospital
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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:
- Patients present with unilateral hemiplegia caused by a first-ever stroke
- Brunnstrom stage above stage II, mental health was stable
- Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23)
Exclusion Criteria:
- Patients having other neurologic problems, which can affect balance and walking ability
- Intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation
- severe hearing or eye problem
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: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Augmented reality with functional electrical stimulation group
Ten participants in group A will undergo 30 minutes interactive augmented reality with functional electrical stimulation intervention and 30 minutes traditional physiotherapy per day, 3 days a week for 8 weeks.
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Experimental group contains 30 minutes augmented reality combined with functional electrical stimulation training, and 30 minutes traditional physiotherapy.
Augmented reality includes treadmill and balance exercise.
Functional electrical stimulation applies on tibialis anterior muscle.
Traditional physiotherapy includes rolling, sitting, standing, overground walking, facilitation of the paretic limbs, and so on.
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활성 비교기: Traditional physiotherapy group
Ten participants in group B will undergo 30 minutes treadmill and balance training as well as 30 minutes traditional conventional physiotherapy a day, 3 days a week, for 8 weeks.
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Traditional physiotherapy includes treadmill and balance training for 30 minutes as well as rolling, sitting, standing, overground walking, facilitation of the paretic limbs for another 30 minutes .
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change of Time Up Go test (TUG)
기간: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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The TUG test will ask participants to stand up, walk for 3 meters, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of Berg Balance Scale (BBS)
기간: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance.
Each task was scored on a 5-point ordinal scale (from 0 to 4).
A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion.
The highest possible score is 56.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of Functional magnetic resonance imaging (fMRI)
기간: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Our study will use 3 Tesla magnetic resonance imaging[GE DISCOVERY MR750w system (GE Healthcare, Milwaukee, Wisconsin)] for functional magnetic resonance imaging.
Resting-state functional MRI image is an echo-planar Image (EPI) technique, using a parameter time of repetition of 2500 milliseconds, time of echo is 30 milliseconds, 43 axial slices,slice thickness is 3 mm, flip angle is 80 degrees, field of view is 192 x 192 millimeters, and vixen size is 3 x 3 x 3 millimeters.
The EPI scan for 525 seconds.
All subjects are asked to close their eyes and supine.
our study uses the fractional amplitude of low-frequency fluctuations analysis to confirm abnormal brain function.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change of Fugl-Meyer Assessment (FMA)-Lower extremity
기간: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control.
Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance).
The total score range from 0 (no motor function) to 34 (good motor recovery).
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of Modified Ashworth Scale (MAS)
기간: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring is recorded as follows: 0: No increase in muscle tone
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of Motor evoked potential (MEP)
기간: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex.
All TMS is delivered with the participant seated upright on the chair.
Both passive and active conditions, participants are instructed to relax their right leg in the seated position.
TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom).
To locate the optimal site, stimuli are delivered over various points along the M1.
The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles.
The onset latency and onset to peak amplitude will be assessed.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of 10 meter walking test
기간: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Individual walks without assistance 10 meters and the time is measured.
Participants will walk 10 meter at preferred walking speed and fastest speed possible, respectively.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of Diffusion Tensor Imaging (DTI)
기간: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Diffusion tensor imaging technique apply to Echo-Planar Image(EPI) technique, fimbriodentate vein is 192X192 mm², time of repetition/time of echo is 11000/110.6
mm, matrix is 72X72 pixels, slice thickness is 2.7 mm. Diffusion weight gradient along 60 directions at b value of 3000/mm².
By observing the reduction of the degree of diffusion anisotropy, to study the recovery of motor function after stroke.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 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 (실제)
2019년 10월 10일
기본 완료 (예상)
2020년 12월 31일
연구 완료 (예상)
2021년 3월 15일
연구 등록 날짜
최초 제출
2019년 6월 27일
QC 기준을 충족하는 최초 제출
2019년 6월 28일
처음 게시됨 (실제)
2019년 7월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 12월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 12월 10일
마지막으로 확인됨
2019년 12월 1일
추가 정보
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Institut National de la Santé Et de la Recherche...모병