- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01121627
Computer-based Cognitive Training for Parkinson Disease
Effects of Computer-based Cognitive Training on Gait Function in Individuals With Parkinson Disease
Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities.
The primary study hypothesis is that computer-based training aimed at improving executive function will have a beneficial effect on gait functions.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Haifa, 이스라엘
- Clalit Health Services, Haifa and Western Galilee District
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Idiopathic PD.
- Aged 50-80, living in north region of Israel.
- Receive regular medications for PD.
- Not suffering from irregular cognitive disturbance or MMSE<25.
- Measured 1-3 on the Hoehn & Yahr scale.
- Have access to a computer and the ability to operate it.
Exclusion Criteria:
- Brain operation, including DBS transplant.
- History of orthopedic problems that can impair gait (hip/knee fractures and back problems).
- Orthopedic operation on lower limbs performed no later than six months prior to the beginning of the study.
- Unbalanced general health: uncontrolled diabetes or blood pressure, etc.
- Inability to walk independently.
- Immunodeficiency diseases, active cancer, ischemic diseases.
- Vision impairment, partial/full blindness.
- Having participated in similar research or cognitive assessment during the previous year.
- Have received cognitive or gait training under physical therapy or other programs.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Computerized cognitive training
A 12 week computerized cognitive training
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A 12 week computerized cognitive training at home with the Attengo™ software program.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gait Function
기간: 18 weeks
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At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements.
Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program.
Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks.
Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.
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18 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Executive function
기간: 18 weeks
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At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements.
Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program.
Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks.
Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.
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18 weeks
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Quality of life.
기간: 18 weeks
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At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements.
Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program.
Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks.
Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-run cognitive and motor changes.
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18 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Uzi Milman, MD, Clalit Health Services
- 수석 연구원: Anat Mirelman, Phd, Tel-Aviv Sourasky Medical Center
- 수석 연구원: Hagit Atias, BA, Clalit Health Services
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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. .