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

Not Applicable

Completed

• Conditions: Alzheimer Disease; Occupational Therapy; Quality of Life; Cognitive Impairment; Older People
• Interventions: Procedure: Conventional occupational therapy sessions; Procedure: Conventional occupational therapy sessions + NeuronUP

• Registration Number: NCT06499272
• Lead Sponsor: Universidad Rey Juan Carlos

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-07
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Study First Submitted: 2024-07-06
• Study First Submitted QC: 2024-07-06
• Last Update Submitted: 2024-07-06
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group (CG	Conventional occupational therapy sessions	Control Group (CG), which received their usual sessions of conventional occupational therapy.
Experimental Group (EG)	Conventional occupational therapy sessions + NeuronUP	Experimental Group (EG), which received therapy with NeuronUP, plus their conventional occupational therapy sessions.

Primary Outcome Measures

Name	Time	Method
Mini Cognitive Examination (MEC)	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)	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	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

Secondary Outcome Measures

Name	Time	Method
The Client Satisfaction Questionnaire-8, CSQ-	Post-intervention (up to 1 week)	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.

Trial Locations

Locations (1)

Physiocare Madrid Clinic; 🇪🇸 Madrid, Spain