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

NCT ID: NCT06499272

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group (EG)

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

Group Type: EXPERIMENTAL

Conventional occupational therapy sessions + NeuronUP

Intervention Type: 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.

Control Group (CG

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

Group Type: ACTIVE_COMPARATOR

Conventional occupational therapy sessions

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Conventional occupational therapy sessions

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

Cristina García-Bravo

PhD, Occupational Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Physiocare Madrid Clinic

Madrid, , Spain

Countries

Spain

Other Identifiers

271120234112023

Identifier Type: -

Identifier Source: org_study_id