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Gli effetti formativi delle attività di ritocco sulla flessibilità cognitiva negli anziani delle comunità

16 settembre 2026 aggiornato da: National Taiwan University Hospital

Aging has been a serious global-wise concern in public health. In particular, elders face declination of cognitive functions that threaten their quality of life. A good approach to slow down cognitive declination during aging processes is therefore in urgent need. According to the Successful Aging model (Rowe, J.W. and Kahn, R.L) participation in meaningful occupational activity may maintains high cognitive and body function. This sub-project is a part of the larger integrated project that will address the need for cognitive promotion by conducting cognitive training interventions on community older adults, utilizing the National Taiwan Science Education Center (NTSEC) as the public recruiting site as well as intervention site. In this sub-project, a 12-week intervention will be carried out with three protocols: 1) Tinkering activities, 2)Controlled Tinkering Activities, and 3) Board Game intervention. Board games serve as a commonly seen cognitive training, with a growing series of literature continuing to support board games being the medium of cognitive promotion. Tinkering activities are primarily used in fields of education that comprise science, art, and technology. Through a series of themes objectives, participants can involve interestingly, creatively, and flexibly in the activity when the participants fulfill the goal with the materials retrievable at the site. The anticipation is that the elders participating in Tinkering activities may increase their cognitive flexibility as the participants involve in the elements hidden within the core of the training, such as problem exploration, active thinking and inference, trial and error, and problem-solving. The investigators target to obtain pre-and post-intervention behavioral and neurophysiological data, including electroencephalogram data in 40 experimental participants, 40 active control participants, and 40 passive control participants over a period of 3 years.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

118

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Taipei, Taiwan, 10051
        • College of Medicine, National Taiwan University
      • Taipei, Taiwan, 11165
        • National Taiwan Science Education Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

65 anni e precedenti (Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Literate in Mandarin and Taiwanese
  • Willing to participate entirely in this research.
  • Age >65

Exclusion Criteria:

  • Participated in cognitive-related training in the past two months.
  • Severe impairment of visual or auditory abilities.
  • Diagnosed with mild cognitive impairment (MCI), or Dementia
  • Severe psychological or behavioral disorder that would seriously interfere with the progress of activity
  • History of degenerative cognitive disorder (e.g., acute stroke, traumatic brain injury, unconscious), organic mental disorders, brain dysfunction, or other neurology-related diagnoses.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Armeggiare

Tinkering activities are activities that comprise elements of science, art, and technology. Through a series of themes objectives, participants can involve interestingly, creatively, and flexibly in the activity when they fulfill the goal with the materials retrievable at the site. Participants will be trained as they involve in the elements hidden within the core of the training, such as problem exploration, active thinking and inference, trial and error, and problem-solving.

Comparatore attivo: Controllo Armeggiare

Controlled Tinkering Activities utilize the themes of Tinkering activities but eliminate the core of Tinkering training, hence implementing a new set of activities that emphasize participants strictly follow procedures to complete the similar objective of Tinkering activities. Each participant will end up with a similar piece of work as Tinkering Activities participants would without problem exploration, active thinking and inference, trial and error, and problem-solving.

Comparatore attivo: Giochi da tavolo

Board games are often constructed with concepts of different cognitive components, such as attention, working memory, planning, calculation; therefore serve as a commonly seen cognitive training, while more and more literature continues to support tabletop games being the medium of cognitive promotion.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes of Event-related potential component (ERP): P2, N2, P3
Lasso di tempo: Week 0, Week 12

The EEG data is recorded while the participants are carrying out the task-switching paradigm. The data will then be analyzed in terms of Event-Related Potential(ERP), where the components' changes will be observed in terms of amplitude and latency.

Week 0, Week 12
Changes of reaction time and accuracy of task-switching paradigm
Lasso di tempo: Week 0, Week 12

The task-switching paradigm will ask the participants to judge whether the number(stimulus) presented is 1) even or odd, OR, 2) more than or less than 5. The switching between these rules will induce a switch cost effect (the time when the rule changes, the reaction time will increase to compensate the cognitive process needed to make the change) if the reaction time decreases after intervention, it implies an improvement.

Week 0, Week 12
Changes of Accuracy in Wisconsin Card Sorting Test
Lasso di tempo: Week 0, Week 12

Score ranged 0-128, the higher the score, the better the executive function

Week 0, Week 12
Changes of Number of Categories Completed in Wisconsin Card Sorting Test
Lasso di tempo: Week 0, Week 12

The number of sequences of 10 consecutive correct matches (maximum = 6), higher the score, the better the executive function

Week 0, Week 12
Changes of Trials to Complete First Category in Wisconsin Card Sorting Test
Lasso di tempo: Week 0, Week 12

Total number of trials to complete first category, the less the score, the better the executive function

Week 0, Week 12
Changes of Percent Perseverative Errors in Wisconsin Card Sorting Test
Lasso di tempo: Week 0, Week 12

The concentration of perseverative errors in relation to overall test performance (the number of trials given) multiplied by 100. The less the score, the better the executive function.

Week 0, Week 12
Changes of Failure to Maintain Set in Wisconsin Card Sorting Test
Lasso di tempo: Week 0, Week 12

When a participant makes five or more consecutive correct matches but then makes an error before successfully completing the category, the less the score, the better the executive function.

Week 0, Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes of University of California, Los Angeles Loneliness Scale
Lasso di tempo: Week 0, Week 12

score ranged 20-80, the higher the greater sense of loneliness in the participants.

Week 0, Week 12
Changes of Geriatric Depression Scale
Lasso di tempo: Week 0, Week 12

Score ranged 0-15, the higher the score, the severe the depressive symptoms.

Week 0, Week 12
Changes of Flow Scale
Lasso di tempo: Week 0, Week 12

Score ranged 1-5, higher the score, the better the flow experience the participant had.

Week 0, Week 12
Changes of Cognitive Flexibility Scale (CFS)
Lasso di tempo: Week 0, Week 12

It is a 12-item 6-point scale in Likert format, the higher the score, the higher the participants' cognitive flexibility.

Week 0, Week 12
Changes of Guilford's Alternative Uses Test (GAU)
Lasso di tempo: Week 0, Week 12

Scoring in terms of originality, fluency, elaboration and flexibility. The higher the score the better the creativity and divergent thinking.

Week 0, Week 12
Changes of Color Trails Test (CTT)
Lasso di tempo: Week 0, Week 12

Measures in time, error, cues, near miss, and color error. The less time, error, cues, near miss and color error the participants take, the better the executive function, alternate and sustain attention.

Week 0, Week 12
Changes of University of California, San Diego Performance-Based Skills Assessment (UPSA-BRIEF)
Lasso di tempo: Week 0, Week 12

Score range 0-100, the higher the score, the better the function of activities of daily living.

Week 0, Week 12
Changes of Remote Associates Test
Lasso di tempo: Week 0, Week 12

Score range 0-30. The higher the score, the better the ability of remote associate creativity.

Week 0, Week 12
Changes of Neural functional activity during inferential processing
Lasso di tempo: Week 0, Week 12

Participants will undergo a Rule Inference functional magnetic resonance imaging task to infer underlying rules that map color configurations of circles in a triangular arrangement to a target color category within as few tries as possible under active or passive conditions. The goal for participants will be to infer the cue-category association rules using as few cues as possible. The primary outcome measure here is the degree of neural response estimate change in blood oxygen level dependent (BOLD) signal pre- and post-intervention.

Week 0, Week 12
Changes of overall accuracy during inferential processing
Lasso di tempo: Week 0, Week 12

Changes from pre- to post-intervention in participant overall accuracy in identifying latent rules in the Rule Inference functional magnetic resonance imaging task.

Week 0, Week 12
Changes of learning rate during inferential processing
Lasso di tempo: Week 0, Week 12

Changes from pre- to post-intervention in participant number of trials to criterion in the Rule Inference functional magnetic resonance imaging task.

Week 0, Week 12
Changes of strategic performance during inferential processing
Lasso di tempo: Week 0, Week 12

Changes from pre- to post-intervention in participant coefficients of expression of modeled response strategies in the Rule Inference functional magnetic resonance imaging task will be assessed.

Week 0, Week 12
Change in Wechsler Memory Scale III Logical Memory I & II
Lasso di tempo: Week 0, Week 12

Score range 0 - 75. Higher score indicates better verbal episodic memory.

Week 0, Week 12
Change in Wechsler Memory Scale III Face Memory
Lasso di tempo: Week 0, Week 12

Score range 0 - 48. Higher score indicates better visual face memory.

Week 0, Week 12
Change in Wechsler Memory Scale III Verbal Paired Memory
Lasso di tempo: Week 0, Week 12

Score range 0 - 32. Higher score indicates better verbal memory and learning.

Week 0, Week 12
Change in Wechsler Memory Scale III Family Pictures I & II
Lasso di tempo: Week 0, Week 12

Score range 0 - 64. Higher score indicates better visual memory and learning.

Week 0, Week 12
Change in Wechsler Memory Scale III Word Lists I & II
Lasso di tempo: Week 0, Week 12

Score range 0 - 36. Higher score indicates better verbal memory and learning. For II, recall score range is 0 to 8; recognition score range is 0 to 24.

Week 0, Week 12
Change in Wechsler Memory Scale III Visual Reproduction I & II
Lasso di tempo: Week 0, Week 12

Score range 0 - 104. Higher score indicates better visual memory. For II, recall score range is 0-104; recognition score range is 0-48.

Week 0, Week 12
Change in Wechsler Memory Scale III Spatial Span
Lasso di tempo: Week 0, Week 12

Score range 0 - 32. Higher score indicates better spatial memory.

Week 0, Week 12
Change in Wechsler Memory Scale III Digit Span
Lasso di tempo: Week 0, Week 12

Score range 0 - 32. Higher score indicates better auditory memory.

Week 0, Week 12
Change in Wechsler Adult Intelligence Scale III Vocabulary
Lasso di tempo: Week 0, Week 12

Score range 0 - 66. Higher score indicates better vocabulary.

Week 0, Week 12
Change in Wechsler Adult Intelligence Scale III Digit Symbol
Lasso di tempo: Week 0, Week 12

Score range 0 - 133. Higher score indicates better processing speed.

Week 0, Week 12
Change in Wechsler Adult Intelligence Scale III Block Design
Lasso di tempo: Week 0, Week 12

Score range 0 - 68. Higher score indicates better visual processing.

Week 0, Week 12
Change in Wechsler Adult Intelligence Scale III Arithmetic
Lasso di tempo: Week 0, Week 12

Score range 0 - 22. Higher score indicates better mathematical computation ability.

Week 0, Week 12
Change in Wechsler Adult Intelligence Scale III Matrix Reasoning
Lasso di tempo: Week 0, Week 12

Score range 0 - 26. Higher score indicates better reasoning.

Week 0, Week 12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Hui-Fen Mao, M.S., National Taiwan University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 febbraio 2021

Completamento primario (Effettivo)

29 luglio 2024

Completamento dello studio (Effettivo)

29 luglio 2024

Date di iscrizione allo studio

Primo inviato

6 aprile 2022

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2022

Primo Inserito (Effettivo)

3 maggio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 dicembre 2024

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 202010050RINB

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Data that can be shared include anonymized neuropsychological assessment scores, cognitive behavioral performance scores, brain imaging data that have been published.

Periodo di condivisione IPD

Data will become available 1 year after primary results are published by the central research team. Data are anticipated to be available for sharing for an indefinite period after the above criteria is met.

Criteri di accesso alla condivisione IPD

Data sharing will be done based direct requests and on case-by-case evaluation for appropriateness. Use of shared data will require agreement on appropriate citation of data sources at least or authorship inclusion or acknowledgement.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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