- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02570256
Deficit Fields for Stroke Recovery
2021년 6월 8일 업데이트: James Patton, Shirley Ryan AbilityLab
Error-enhanced Learning & Recovery in 2 & 3 Dimensions
This study investigates the potential of customized robotic and visual feedback interaction to improve recovery of movements in stroke survivors.
While therapists widely recognize that customization is critical to recovery, little is understood about how take advantage of statistical analysis tools to aid in the process of designing individualized training.
Our approach first creates a model of a person's own unique movement deficits, and then creates a practice environment to correct these problems.
Experiments will determine how the deficit-field approach can improve (1) reaching accuracy, (2) range of motion, and (3) activities of daily living.
The findings will not only shed light on how to improve therapy for stroke survivors, it will test hypotheses about fundamental processes of practice and learning.
This study will help us move closer to our long-term goal of clinically effective treatments using interactive devices.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
45
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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Illinois
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Chicago, Illinois, 미국, 60611
- Rehabilitation Institute of Chicago
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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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
STROKE SURVIVORS:
- adult (age >18)
- Chronic stage stroke recovery (8+ months post)
- available medical records and radiographic information about lesion locations
- strokes caused by an ischemic infarct in the middle cerebral artery
- primary motor cortex involvement
- a Fugl-Meyer score (between 15-50) to evaluate arm motor impairment level
HEALTHY CONTROL PARTICIPANTS:
- adult (age >18)
- healthy individuals with no history of stroke or neural injury
Exclusion Criteria:
- bilateral paresis;
- severe sensory deficits in the limb
- severe spasticity (Modified Ashworth of 4) preventing movement
- aphasia, cognitive impairment or affective dysfunction that would influence the ability to perform the experiment
- inability to provide an informed consent
- severe current medical problems
- diffuse/multiple lesion sites or multiple stroke events
- hemispatial neglect or visual field cut that would prevent subjects from seeing the targets.
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Deficit-fields to reduce error
We hypothesize that a deficit-field design, using the statistics of a patient's errors to customize training, will provide optimal augmentation that varies during motion as needed.
We will compare the training effects of error deficit-fields with previous methods of error augmentation to improve reaching ability.
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Stroke survivors exhibit error in both reaching extent and abnormal curvatures of motion.
Prior error augmentation techniques multiply error by a constant at each instant during movement.
However, magnification of spurious errors may provoke over-compensation.
We hypothesize that a deficit-field design, using the statistics of a patient's errors to customize training, will provide optimal augmentation that varies during motion as needed.
We will compare the training effects of error deficit-fields with previous methods of error augmentation to improve reaching ability.
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실험적: Deficit-fields to expand range of motion
Amplifying augmentation can expand motor exploration and improve skill retention in patients.
Using motor exploration patterns from each patient, we will form customized deficit-fields to recover normal joint workspace.
We will compare augmentation training that either amplifies or diminishes the observed deficits (Expt-1).
We also compare deficit-fields with our prior augmentation methods to determine the added value of increased customization (Expt-2).
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Motor deficits manifest in the workspace limitations of joints, i.e. reduced range of motion, uneven extension-flexion, inter-joint coupling, and unwanted synergies.
Our work builds upon these ideas by augmenting self-directed movement for training coordination.
We found that amplifying augmentation can expand motor exploration and improve skill retention in patients.
Using motor exploration patterns from each patient, we will form customized deficit-fields to recover normal joint workspace.
We will compare augmentation training that either amplifies or diminishes the observed deficits (Expt-1).
We also compare deficit-fields with our prior augmentation methods to determine the added value of increased customization (Expt-2).
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실험적: Deficit-fields to improve function
Here we present visual distortion of whole body movement during manual tasks during standing, including reaching, grasping, and object manipulation.
We compare the training effects of feedback based on deficit-fields versus practice with normal vision.
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Clinicians have recognized the benefits of training on everyday tasks (Hubbard, Parsons et al. 2009), as well as practice with whole-body actions (Boehme 1988; Bohannon 1995).
However, typical robotic systems have only a single contact point and cannot drive the multiple joints involved in functional tasks.
Visual distortions (e.g. a shift, rotation or stretch) can promote adaptation even without forces.
Here we present visual distortion of whole body movement during manual tasks during standing, including reaching, grasping, and object manipulation.
We compare the training effects of feedback based on deficit-fields versus practice with normal vision.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Arm motor recovery scores on the Fugl-Meyer
기간: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline in arm motor recovery as measured by Fugl-Meyer
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of blocks transferred in Box and Blocks Test
기간: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline in number of blocks transferred during Box and Blocks Test
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Modified Ashworth Scale (MAS)
기간: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline in amount of spasticity in elbow flexors and extensors
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Elbow active range of motion (ROM)
기간: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline measured in degrees for elbow flexion and extension
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Chedoke McMaster Stroke Assessment for Hand
기간: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change in baseline in amount of hand motor recovery as measured by Chedoke scale
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Time and completion score for Action Research Arm Test (ARAT)
기간: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change in baseline score and time for completion of functional measures as part of ARAT
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: James L Patton, PhD, Shirley Ryan AbilityLab
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 (실제)
2013년 5월 1일
기본 완료 (실제)
2019년 6월 30일
연구 완료 (실제)
2019년 6월 30일
연구 등록 날짜
최초 제출
2015년 10월 1일
QC 기준을 충족하는 최초 제출
2015년 10월 6일
처음 게시됨 (추정)
2015년 10월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 6월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 6월 8일
마지막으로 확인됨
2018년 10월 1일
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