- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03195829
Feasibility Study of a Computerized Cognitive Stimulation (PSCogStim)
A Computerized Cognitive Stimulation Program in Elderly With Mild Cognitive Impairment: A Feasibility Study
연구 개요
상세 설명
Involvement in social and leisure activities has been associated with a decreased risk of dementia in the elderly with Mild Cognitive Impairment (MCI). MCI is a crucial phase to prevent the worsening of cognitive decline in elderly at risk to develop dementia. These last years, the use of computerized training programs to enhance cognitive functioning showed positive and promising results. However, the effects on psychosocial factors still poorly documented in cognitive interventions in MCI. It seems essential to promote these factors involving social ties, group dynamic, the motivation, as factors that can contribute to enhance social life and cognitive functioning.
This feasibility study evaluated a computer-based cognitive stimulation in elderly with MCI and explore the effects on cognitive and psychosocial components.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinical diagnosis of Mild Cognitive Impairment
- Absence of history of alcohol or other substance consumption
- No engagement in other cognitive intervention program
Exclusion Criteria:
- Psychiatric and neurological disorders
- Conversion toward dementia during intervention
- Sensory and or motor deficit that could interfere with the use of computer tool
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Computerized cognitive stimulation
Computerized Cognitive Stimulation was administered to intervention group (IG).
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The intervention group performed 12-week, 90-minutes per week of cognitive stimulation in group using a tablet with a commercial software with specific exercises to train the cognitive functioning and promote the relation ties in group-session.The program's difficulty level was adjusted to the MMSE score, and was gradually increased.
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활성 비교기: Multimedia-based internet activities
Multimedia-based internet activities was administered to active control group (ACG).
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The active control group had access to different Multimedia contents (travel, photos, music, TV program, cooking recipes) using a tablet, 90-minutes per week each week during 3-months.
Each group session was centered in a particular topic, participants were able to select different media free available in Internet.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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GROBER-BUSCHKE TEST
기간: Baseline assessment before intervention, change from baseline at 3 months immediately after intervention
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Assessment of free and cued recall of episodic memory
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Baseline assessment before intervention, change from baseline at 3 months immediately after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Technologies Acceptation Questionnaire
기간: Baseline assessment before intervention, change from baseline at 3 months immediately after intervention
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Assessment of acceptability of communication and information technologies
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Baseline assessment before intervention, change from baseline at 3 months immediately after intervention
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공동 작업자 및 조사자
스폰서
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 (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. .
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