The Impact of Multi-Touch Functional Digital Game on Intelligence and Vitality for the Community-dwelling Elderly
2022年9月20日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
32
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Seoul、大韓民国、06351
- Samsung Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年～84年 (高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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)
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実験的：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.
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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)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline performance on Stroop test (Neuropsychological test) after the intervention (Day 13).
時間枠：Baseline, After the intervention (Day 13)
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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.
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Baseline, After the intervention (Day 13)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline performance on Fluency Test (Neuropsychological test) after the intervention (Day 13).
時間枠：Baseline, After the intervention (Day 13)
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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).
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Baseline, After the intervention (Day 13)
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Change from baseline performance on Trail Making Test (Neuropsychological test) after the intervention (Day 13).
時間枠：Baseline, After the intervention (Day 13)
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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.
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Baseline, After the intervention (Day 13)
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Change from baseline performance on Digit Span Test (Neuropsychological test) after the intervention (Day 13).
時間枠：Baseline, After the intervention (Day 13)
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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.
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Baseline, After the intervention (Day 13)
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Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) after the intervention (Day 13).
時間枠：Baseline, After the intervention (Day 13)
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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.
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Baseline, After the intervention (Day 13)
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Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) during the intervention(Day 1 and 12)and after intervention completion(Day 12)
時間枠：Baseline, during the intervention(Day 1 and 12), Through intervention completion(Day 12)
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It measures brain activity during cognitive tasks to see if cognitive training affects brain function.
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Baseline, during the intervention(Day 1 and 12), Through intervention completion(Day 12)
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Change from baseline activity on Contrasting Program/Go-No-Go test after the intervention (Day 13).
時間枠：Baseline, Day 13(After the intervention)
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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.
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Baseline, Day 13(After the intervention)
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Change from baseline activity on Geriatric Depression Scale (GDS) after the intervention (Day 13).
時間枠：Baseline, After the intervention (Day 13)
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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
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Baseline, After the intervention (Day 13)
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Change from baseline activity on health-related quality of life instrument with 20 items (HINT-20) after the intervention (Day 13).
時間枠：Baseline, After the intervention (Day 13)
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The total score of the HINT-20 is converted to a 0-100 scale, with higher scores indicating better health-related quality of life.
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Baseline, After the intervention (Day 13)
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Change from baseline activity on General Self-Efficacy Scale (GSE) after the intervention (Day 13).
時間枠：Baseline, After the intervention (Day 13)
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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.
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Baseline, After the intervention (Day 13)
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Change from baseline activity on International Physical Activity Questionnaire after the intervention (Day 13).
時間枠：Baseline, After the intervention (Day 13)
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Physical Activity Questionnaire collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions.
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Baseline, After the intervention (Day 13)
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User Satisfaction Questionnaire after intervention.
時間枠：After the intervention (Day 13)
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We evaluate the satisfaction questionnaire for each training.
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After the intervention (Day 13)
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Change from baseline activity on smart band activity through intervention completion(Day 12).
時間枠：Baseline, through intervention completion(Day 12)
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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).
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Baseline, through intervention completion(Day 12)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年9月16日
一次修了 (実際)
2022年2月21日
研究の完了 (実際)
2022年8月4日
試験登録日
最初に提出
2021年4月5日
QC基準を満たした最初の提出物
2021年5月4日
最初の投稿 (実際)
2021年5月5日
学習記録の更新
投稿された最後の更新 (実際)
2022年9月22日
QC基準を満たした最後の更新が送信されました
2022年9月20日
最終確認日
2021年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2021-03-011
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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