Alzheimer DiseaseNCT06499272
Quality-of-Life-and-Cognitive-Oriented Rehabilitation Through the NeuronUP in Alzheimer's Disease
A study testing Conventional occupational therapy sessions + NeuronUP and Conventional occupational therapy sessions in people with Alzheimer Disease and Occupational Therapy, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Occupational Therapy, Quality of Life
- What is being tested?
- Conventional occupational therapy sessions + NeuronUP and Conventional occupational therapy sessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality-of-Life-and-Cognitive-Oriented Rehabilitation Program Through the NeuronUP in Older People With Alzheimer's Disease: A Randomized Clinical Trial
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
- Being tested
- Conventional occupational therapy sessions + NeuronUP, Conventional occupational therapy sessions
- Keywords
- Alzheimer's Disease, Occupational Therapy, NeuronUP, Quality of Life, Cognitive Stimulation, Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional occupational therapy sessions + NeuronUPProcedure or surgery
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 sessionsProcedure or surgery
Occupational therapy sessions are based on cognitive stimulation, manipulative dexterity training and psychomotor skills.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | Experimental Group (EG), which received therapy with NeuronUP, plus their conventional occupational therapy sessions. Receives: Procedure: Conventional occupational therapy sessions + NeuronUP |
| Control Group (CG | Active comparator | Control Group (CG), which received their usual sessions of conventional occupational therapy. Receives: Procedure: Conventional occupational therapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Post-intervention (up to 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Dec 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina García-Bravo, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499272
- Sponsor's protocol ID
- 271120234112023
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu Y, Qian Q, Li J, Wang Y, Zhu Y, Shi N, Zhang H, Yan F, Ma Y. Adherence to cognitive training in patients with mild cognitive impairment and dementia: A systematic review and meta-analysis. Neuropsychol Rehabil. 2026 Oct 15:1-18. doi: 10.1080/09602011.2026.2738748. Online ahead of print.
PubMed 42885312
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality-of-Life-and-Cognitive-Oriented Rehabilitation Program Through the NeuronUP in Older People With Alzheimer's Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06499272
- Acronym / sponsor ID
- 271120234112023
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Procedure: Conventional occupational therapy sessions + NeuronUPExperimental Group (EG), which received therapy with NeuronUP, plus their conventional occupational therapy sessions. |
| Control Group (CG | Active comparator | Procedure: Conventional occupational therapy sessionsControl Group (CG), which received their usual sessions of conventional occupational therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional occupational therapy sessions + NeuronUPOccupational 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. | Procedure or surgery | Experimental Group (EG) |
| Conventional occupational therapy sessionsOccupational therapy sessions are based on cognitive stimulation, manipulative dexterity training and psychomotor skills. | Procedure or surgery | Control Group (CG |
Primary outcome
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
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).
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.
1 secondary outcome
The Client Satisfaction Questionnaire-8, CSQ-
Time frame: Post-intervention (up to 1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 42885312Zhu Y, Qian Q, Li J, Wang Y, Zhu Y, Shi N, Zhang H, Yan F, Ma Y. Adherence to cognitive training in patients with mild cognitive impairment and dementia: A systematic review and meta-analysis. Neuropsychol Rehabil. 2026 Oct 15:1-18. doi: 10.1080/09602011.2026.2738748. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional occupational therapy sessions + NeuronUP and Conventional occupational therapy sessions in people with Alzheimer Disease and Occupational Therapy, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization WHOQOL-BREF (time frame: Pre-intervention and post-intervention (up to 1 week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06499272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.