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临床试验/NCT06499272
NCT06499272已完成不适用

Quality-of-Life-and-Cognitive-Oriented Rehabilitation Program Through the NeuronUP in Older People With Alzheimer's Disease: A Randomized Clinical Trial

Universidad Rey Juan Carlos2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年12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
35
试验地点
2
主要终点
Mini Cognitive Examination (MEC)

研究概览

简要总结

Introduction: New technologies are a support in the rehabilitation of users. The therapeutic approach to cognitive rehabilitation encompasses a variety of techniques, among which traditional occupational therapy stands out. This modality includes a series of interventions such as cognitive stimulation through the use of cards, functional activities, psychomotor exercises, the application of sensory stimuli and the incorporation of music therapy. An additional alternative is to integrate a cognitive stimulation program such as NeuronUP, which is a computerized tool. This integration can increase adherence to treatment and contribute to preserving or improving the individual's cognitive functioning and improving quality of life.

Objective: The objective established for this study was to verify whether the combination of occupational therapy with the NeuronUP computer program improves or maintains the cognitive status and quality of life of users with Alzheimer's disease. In addition, to determine whether the use of this program leads to greater adherence to treatment by patients.

Material and methods: This is a randomized clinical trial. Participants' cognitive status will be assessed using the MEC (Mini Cognitive Examination) tool, cognitive skills using the LOTCA (Loewenstein Occupational Therapy Cognitive Assessment), and perceived quality of life using the Whoqol-Bref questionnaire. At the end of treatment, the CSQ-8, a tool designed to determine the degree of user satisfaction, will be administered.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult men or women, aged 65 years or olde.
  • Not present severe cognitive impairment, measured through the Mini Cognitive Examination test (MEC>22 points).
  • To reside permanently in the Nursing Home.
  • Attend Occupational Therapy sessions regularly.
  • Have adequate manual dexterity to be able to use a Tablet.
  • Agree to participate voluntarily in the study.

排除标准

  • Having severe cognitive impairment, as measured by the Mini Cognitive Examination (MEC<22 points).
  • Having comorbid diagnoses such as stroke, brain tumours or heart disease, among others.
  • Not attending Occupational Therapy sessions regularly.
  • Poor adherence to the treatments offered at the centre.
  • Not agreeing to participate voluntarily in the study.

结局指标

主要结局

Mini Cognitive Examination (MEC)

时间窗: Pre-intervention and post-intervention (up to 1 week)

This test provides information about a person's cognitive state. By means of the score obtained, cognitive impairment can be perceived, being useful for screening purposes. The scores are: No impairment (between 24 and 35 points); probably moderately impaired (between 23 and 18 points); and severely impaired (less than 18 points).

Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)

时间窗: Pre-intervention and post-intervention (up to 1 week)

Tool adapted and validated for the Spanish population that assesses cognitive skills in four areas: orientation, visual and spatial perception, visual motor organisation and thinking operations. Scores range from 1 to 4, with the highest score being the best.

World Health Organization WHOQOL-BREF

时间窗: Pre-intervention and post-intervention (up to 1 week)

Self-administered questionnaire, assesses the general perception of quality of life and general perception of health. It is composed of four domains: physical health, psychological health, social relationships and environment. A higher score on this scale indicates a higher quality of life. Potential scores for all domain scores, therefore, range from 4-20

次要结局

  • The Client Satisfaction Questionnaire-8, CSQ-(Post-intervention (up to 1 week))

研究者

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

Cristina García-Bravo

PhD, Occupational Therapist

Universidad Rey Juan Carlos

研究点 (2)

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