CClinicalTrials.gg
CompletedNCT06499272Updated Jul 12, 2024

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

An interventional study of Conventional occupational therapy sessions + NeuronUP and Conventional occupational therapy sessions in Alzheimer Disease, Occupational Therapy and Quality of Life, sponsored by Universidad Rey Juan Carlos. Completed at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2023, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Alzheimer Disease

3,681 studies on the registry are indexed under Alzheimer Disease; 875 are open to participants now.

This study's enrollment of 35 is below the median of 70 across 2,809 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Universidad Rey Juan Carlos is the lead sponsor of 111 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Experimental Group (EG)

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

    Procedure: Conventional occupational therapy sessions + NeuronUP

  • Active comparator
    Control Group (CG

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

    Procedure: Conventional occupational therapy sessions

Interventions

  • ProcedureConventional 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.

  • ProcedureConventional occupational therapy sessions

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Pre-intervention and post-intervention (up to 1 week)

  2. 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).

    Time frame: Pre-intervention and post-intervention (up to 1 week)

  3. 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.

    Time frame: Pre-intervention and post-intervention (up to 1 week)

Secondary outcomes

  1. 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.

    Time frame: Post-intervention (up to 1 week)

07

Study locations

1 site
  • Physiocare Madrid Clinic
    Madrid, 28026, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06499272
Lead sponsor
Universidad Rey Juan Carlos
Responsible party
Cristina García-Bravo (PhD, Occupational Therapist, Universidad Rey Juan Carlos) — Principal investigator
First posted
Jul 12, 2024
Start date
Dec 1, 2023
Primary completion
Jul 1, 2024
Completion
Jul 1, 2024
Last update
Jul 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion