Quality-of-Life-and-Cognitive-Oriented Rehabilitation Through the NeuronUP in Alzheimer's Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Cognitive Impairment; Alzheimer Disease; Older People; Occupational Therapy
• Intervention / Treatment: Procedure: Conventional occupational therapy sessions + NeuronUP; Procedure: Conventional occupational therapy sessions

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28026
    • Physiocare Madrid Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group (EG); Experimental Group (EG), which received therapy with NeuronUP, plus their conventional occupational therapy sessions.	Procedure: Conventional occupational therapy sessions + NeuronUP; Occupational therapy sessions are based on cognitive stimulation, manipulative skill training and psychomotor skills. In addition, 2 sessions per week are conducted with two Nintendo Switch games.
Active Comparator: Control Group (CG; Control Group (CG), which received their usual sessions of conventional occupational therapy.	Procedure: Conventional occupational therapy sessions; Occupational therapy sessions are based on cognitive stimulation, manipulative dexterity training and psychomotor skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization WHOQOL-BREF	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	Pre-intervention and post-intervention (up to 1 week)
Mini Cognitive Examination (MEC)	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).	Pre-intervention and post-intervention (up to 1 week)
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)	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.	Pre-intervention and post-intervention (up to 1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Client Satisfaction Questionnaire-8, CSQ-	Self-administered questionnaire used to evaluate satisfaction with the care services received, it consists of 8 questions. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction). Total scores range from 8 to 32, with higher scores indicating greater satisfaction.	Post-intervention (up to 1 week)

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: July 6, 2024
• First Submitted That Met QC Criteria: July 6, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 6, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Alzheimer's Disease; Cognitive Impairment; Occupational Therapy; Cognitive Stimulation; NeuronUP
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 271120234112023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No