Clinical trial NCT06499272: Quality-of-Life-and-Cognitive-Oriented Rehabilitation Through the NeuronUP in Alzheimer's Disease
Official title: Quality-of-Life-and-Cognitive-Oriented Rehabilitation Program Through the NeuronUP in Older People With Alzheimer's Disease: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Occupational Therapy
Quality of Life
Cognitive Impairment
Older People
Keywords: Alzheimer's Disease
Occupational Therapy
NeuronUP
Quality of Life
Cognitive Stimulation
Cognitive Impairment
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 35
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ontrol Group (CG), which received their usual sessions of conventional occupational therapy, and an Experimental Group (EG), which received therapy with NeuronUP, plus their conventional occupational therapy sessions.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: World Health Organization WHOQOL-BREF
timeFrame: Pre-intervention and post-intervention (up to 1 week)
measure: Mini Cognitive Examination (MEC)
timeFrame: Pre-intervention and post-intervention (up to 1 week)
measure: Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
timeFrame: Pre-intervention and post-intervention (up to 1 week)
Secondary outcomes:
measure: The Client Satisfaction Questionnaire-8, CSQ-
timeFrame: Post-intervention (up to 1 week)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Physiocare Madrid Clinic
Study officials:
References: