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Completed

NCT Number: NCT06499272

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Occupational Therapy Older People Quality of Life Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiocare Madrid Clinic

Madrid, 28026, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Conventional occupational therapy sessions

Procedure

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

Primary outcomes

  1. World Health Organization WHOQOL-BREF

    Time frame: 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

  2. Mini Cognitive Examination (MEC)

    Time frame: 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).

  3. Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)

    Time frame: 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.

Secondary outcomes

  1. The Client Satisfaction Questionnaire-8, CSQ-

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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