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The Impact of Multi-Touch Functional Digital Game on Intelligence and Vitality for the Community-dwelling Elderly

2022년 9월 20일 업데이트: Samsung Medical Center
This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.

연구 개요

상세 설명

At the first visit, the subjects are fully informed of the study if appropriate after determining whether they meet the selection criteria. This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.

연구 유형

중재적

등록 (실제)

32

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Seoul, 대한민국, 06351
        • Samsung Medical Center

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

65년 (고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • community-dwelling senior citizens aged 65 to 84
  • Those without a history of central nervous system(CNS) disease

Exclusion Criteria:

  • When it is difficult to understand the task performance due to severe cognitive decline(Korean Simple Mental State Test, K-MMSE 10 points or less).
  • When it is difficult to use this game device due to problems such as decreased vision or fracture of the upper limb
  • In case of accompanying serious mental illness

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Functional digital game training group
These functional digital game programs have been developed to improve the intelligence and vitality in the community-dwelling elderly. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.
Functional digital game training group is divided in 16 participants. In one session, participants in the functional digital game training group completed 40 minutes of intervention using various functional digital game such as working memory, memory, and attention. (Total 10 session)
실험적: Individual cognitive training
Individual cognitive training has been used to improve the intelligence and cognitive function in community-dwelling elderly. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.
Functional digital game training group is divided in 16 participants. In one session, participants in the individual cognitive training group completed 40 minutes of intervention using various cognitive training such as working memory, memory, and attention. (Total 10 session)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13).
기간: Baseline, After the intervention (Day 13)
It measures a participant's processing speed, selective attention and inhibitory control. The participant will be asked to read 'word' of the colored words or 'name of the color' of the colored words in separate trials. The main scores produced in this test are completion time and errors. The contrast score of the two trial's completion time means interference.
Baseline, After the intervention (Day 13)

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline performance on Fluency Test (Neuropsychological test) after the intervention (Day 13).
기간: Baseline, After the intervention (Day 13)
This is a generative naming test. That measure how many words you can spontaneously speak within a limited time of words that fall into a specific category (e.g. animals, store goods, vegetables) or words starting with a letter (e.g. F • A • S or C·F·L).
Baseline, After the intervention (Day 13)
Change from baseline performance on Trail Making Test (Neuropsychological test) after the intervention (Day 13).
기간: Baseline, After the intervention (Day 13)
It consists of type A and type B trials. The participant should connect the numbers (1~25) as quickly as possible in Type A trial, and connect the numbers (1~13) and alphabets (A~L) alternatively as quickly as possible in type B trial. The main scores produced in this test are completion time and errors. Higher score means worse performance.
Baseline, After the intervention (Day 13)
Change from baseline performance on Digit Span Test (Neuropsychological test) after the intervention (Day 13).
기간: Baseline, After the intervention (Day 13)
It measures auditory attention span and includes forward and backward trials. The participant listens to a series of numbers and calls the sequence correctly. The sequence increases in each trial. The final score is the longest number of sequential digits that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.
Baseline, After the intervention (Day 13)
Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) after the intervention (Day 13).
기간: Baseline, After the intervention (Day 13)
It measures participant's verbal memory. The participant will hear 15 words and recall them immediately and after 20 minutes again. The main scores produced in this test are the numbers of recalled words of the immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.
Baseline, After the intervention (Day 13)
Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) during the intervention(Day 1 and 12)and after intervention completion(Day 12)
기간: Baseline, during the intervention(Day 1 and 12), Through intervention completion(Day 12)
It measures brain activity during cognitive tasks to see if cognitive training affects brain function.
Baseline, during the intervention(Day 1 and 12), Through intervention completion(Day 12)
Change from baseline activity on Contrasting Program/Go-No-Go test after the intervention (Day 13).
기간: Baseline, Day 13(After the intervention)
The Contrasting Program and go-no go test requires a subject to emit a simple motor response to one cue while inhibiting the response in the presence of another cue. This test has been effective in demonstrating impulsivity (elevated commission error rate) in elderly with attention deficit.
Baseline, Day 13(After the intervention)
Change from baseline activity on Geriatric Depression Scale (GDS) after the intervention (Day 13).
기간: Baseline, After the intervention (Day 13)
GDS is a 15-item self-report assessment used to identify depression in the elderly. A score of 0 to 5 is normal. A score greater than 5 suggests depression
Baseline, After the intervention (Day 13)
Change from baseline activity on health-related quality of life instrument with 20 items (HINT-20) after the intervention (Day 13).
기간: Baseline, After the intervention (Day 13)
The total score of the HINT-20 is converted to a 0-100 scale, with higher scores indicating better health-related quality of life.
Baseline, After the intervention (Day 13)
Change from baseline activity on General Self-Efficacy Scale (GSE) after the intervention (Day 13).
기간: Baseline, After the intervention (Day 13)
General self-efficacy (GSE), individuals'belief in their ability to perform well in a variety of situations. General self-efficacy (GSE) is the belief in one's competence to attempt difficult or novel tasks, and to cope with adversity arising from specific demanding situations.
Baseline, After the intervention (Day 13)
Change from baseline activity on International Physical Activity Questionnaire after the intervention (Day 13).
기간: Baseline, After the intervention (Day 13)
Physical Activity Questionnaire collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions.
Baseline, After the intervention (Day 13)
User Satisfaction Questionnaire after intervention.
기간: After the intervention (Day 13)
We evaluate the satisfaction questionnaire for each training.
After the intervention (Day 13)
Change from baseline activity on smart band activity through intervention completion(Day 12).
기간: Baseline, through intervention completion(Day 12)
Each participant was given an smart band(number of steps count) and instructed to wear it on the wrist during waking hours until completion of the training program. This included both intervening training days (totaling 10).
Baseline, through intervention completion(Day 12)

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)

2021년 9월 16일

기본 완료 (실제)

2022년 2월 21일

연구 완료 (실제)

2022년 8월 4일

연구 등록 날짜

최초 제출

2021년 4월 5일

QC 기준을 충족하는 최초 제출

2021년 5월 4일

처음 게시됨 (실제)

2021년 5월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 9월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 9월 20일

마지막으로 확인됨

2021년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2021-03-011

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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