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临床试验/NCT05038579
NCT05038579已完成不适用

Clinical Validation of a Cognitive Stimulation Platform for Individuals With Dementia - Musiquence

Universidade da Madeira2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Mini-Mental State Examination (Cognitive Screening) (MMSE)

研究概览

简要总结

Dementia is a neurodegenerative syndrome that leads to cognitive deficits and, consequently, affects functionality and quality of life.

This study will explore the clinical impact of a customized cognitive stimulation program, using Musiquence.

详细描述

Dementia is a clinical syndrome characterized by a progressive and irreversible deterioration of cognitive functioning that impairs behavioral and functional domains. Within non-pharmacological approaches, Cognitive Stimulation Therapy (CST) is the most studied and well-established intervention for individuals with mild to moderate dementia. The underlying assumptions behind cognitive-based interventions of CST are:

  1. IwD can benefit from cognitive stimulation if mobilized relatively preserved cognitive functions (e.g., crystallized abilities such as semantic memory and verbal skills), and;
  2. Even in advanced age, exposure to enriched environments (i.e., socially and cognitively challenging) can enhance cognitive reserve and neuroplasticity.

Concerning the first assumption of cognitive-based interventions (a1), it is known that even in moderate to advanced stages of dementia, musical memory is one of the abilities that remain intact. It is hypothesized that music processing abilities precede the development of lexical language functions. This hypothesis is corroborated by findings that demonstrate that IwD are still responsive to music even when unable to communicate verbally or recognize words. Additionally, music is frequently associated with life experiences. Also, literature has reported that memories associated with specific music would be recollected longer than memories with no association to music; this suggests that using music as a reminiscence element on cognitive stimulation programs can have a promising effect on cognition. According to the second assumption of CST (a2), facilitating an enriching environment for IwD using, for , music and reminiscence elements could impact cognitive reserve and neuroplasticity.

In this context, Ferreira et al. developed a platform - Musiquence - that incorporates music and reminiscence in cognitive stimulation activities for IwD. Musiquence allows the gamification and personalization of 6 types of activities:

  • Reality Orientation - a quiz-like activity that includes date and time information.
  • Creative Drawings - a puzzle-like game in which the participant draws the missing pieces.
  • Activities of Daily Living (ADL) - a puzzle-like game in which the participants have to perform a set of chores (i.e., brush the teeth), and the missing pieces are completed with real physical objects (i.e., toothpaste).
  • Search Objects activity - exploration game in which the participants must find hidden images (e.g., cats) that are only visible through a virtual magnifying glass.
  • Knowledge Quiz - participants must select the correct answer to a question among incorrect ones.
  • Association activity - participants must categorize the items according to the instructions. For example, separate cars from motorcycles and locate them in the correct container.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Mild to moderate stage of dementia (with formal diagnosis);
  • Ability to move upper limbs;
  • Maintained auditory acuity;
  • Relatively preserved language skills.

排除标准

  • Moderate to severe depressive symptomatology;
  • Moderate to severe anxious symptomatology;
  • Bedridden.

结局指标

主要结局

Mini-Mental State Examination (Cognitive Screening) (MMSE)

时间窗: Baseline, Post-intervention (7 weeks), Follow-up (3 months)

Change from baseline in the MMSE. Minimum of 0 points and maximum of 30 points. Higher scores mean better outcomes.

Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS - Cog)

时间窗: Baseline, Post-intervention (7 weeks), Follow-up (3 months)

Change from baseline in the ADAS-Cog. Minimum of 0 points and maximum of 68 points. Higher scores mean worse outcomes.

次要结局

  • Quality of Life - Alzheimer's Disease (QoL - AD)(Baseline, Post-intervention (7 weeks), Follow-up (3 months))
  • Kettler Laurent Thierreau (KLT)(Baseline, Post-intervention (7 weeks), Follow-up (3 months))
  • Symbol Search - Weschler Adult Inteligence Scale 3rd edition (SR)(Baseline, Post-intervention (7 weeks), Follow-up (3 months))
  • Rating Anxiety in Dementia (RAID) scale.(Baseline, Post-intervention (7 weeks), Follow-up (3 months))
  • Semantic and Phonemic Verbal Fluency (SPVF)(Baseline, Post-intervention (7 weeks), Follow-up (3 months))
  • Digital Symbol Coding - Weschler Adult Inteligence Scale 3rd edition (DSC)(Baseline, Post-intervention (7 weeks), Follow-up (3 months))
  • Cornell Scale for Depression in Dementia(Baseline, Post-intervention (7 weeks), Follow-up (3 months))
  • Adults and Older Adults Functional Assessment Inventory (IAFAI)(Baseline, Post-intervention (7 weeks), Follow-up (3 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergi Bermúdez i Badia

Associate Professor at the University of Madeira and Senior Researcher at NOVA-LINCS

Universidade da Madeira

研究点 (2)

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