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

NCT06499272 | Completed DMC

• 1 other identifier: 271120234112023
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The Client Satisfaction Questionnaire-8, CSQ-

  Post-intervention (up to 1 week)

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

Experimental Group (EG), which received therapy with NeuronUP, plus their conventional occupational therapy sessions.

Procedure: Conventional occupational therapy sessions + NeuronUP

Control Group (CG

ACTIVE COMPARATOR

Control Group (CG), which received their usual sessions of conventional occupational therapy.

Procedure: Conventional occupational therapy sessions

Interventions

Conventional occupational therapy sessions + NeuronUP PROCEDURE

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.

Experimental Group (EG)

Conventional occupational therapy sessions PROCEDURE

Occupational therapy sessions are based on cognitive stimulation, manipulative dexterity training and psychomotor skills.

Control Group (CG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Physiocare Madrid Clinic

Madrid, 28026, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Occupational Therapist

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 12, 2024
• Study Start: December 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)