Cognitive ImpairmentNCT06129630
Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment
A study testing Conventional occupational therapy sessions. and Conventional occupational therapy sessions + Nintendo Switch in people with Cognitive Impairment and Elderly People, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Purpose: Healthy aging is the process of optimizing opportunities for health, participation and safety in order to improve quality of life as people age. This study aimed to provide healthy aging for people with cognitive impairment through the use of the Nintendo Switch combined with Occupational Therapy sessions. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Elderly People, Healthy Aging
- What is being tested?
- Conventional occupational therapy sessions. and Conventional occupational therapy sessions + Nintendo Switch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 28 Dec 2023
- 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 older, cohabitating in the nursing home.
- Not presenting moderate or severe cognitive impairment measured through the MEC- Lobo test (score ≥ 24-35) (20).
- Agree to participate voluntarily, having read the project information sheet and signed the informed consent.
Who cannot join
- Presence of neurodegenerative pathology.
- Presence of physical pathology that compromised the person's safety.
- Severe cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment: A Randomized Clinical Trial
Purpose: Healthy aging is the process of optimizing opportunities for health, participation and safety in order to improve quality of life as people age. This study aimed to provide healthy aging for people with cognitive impairment through the use of the Nintendo Switch combined with Occupational Therapy sessions.
Material and methods: a randomized clinical trial was conducted. The sample was randomized using a software program, OxMar, which allowed the separation of the sample into a control group (CG), which received their usual sessions of conventional occupational therapy, and an experimental group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions. An 8-week intervention was conducted with Nintendo Switch.
Measures: Nine Hole Peg Test, Box and Block Test, Barthel Index, WHOQOL-BREF, CSQ-8.
- Being tested
- Conventional occupational therapy sessions., Conventional occupational therapy sessions + Nintendo Switch
- Medical subject headings
- 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.Procedure or surgery
Occupational therapy sessions are based on cognitive stimulation, manipulative dexterity training and psychomotor skills.
Conventional occupational therapy sessions + Nintendo SwitchProcedure 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CG) | Active comparator | Control Group (CG), which received their usual sessions of conventional occupational therapy. Receives: Procedure: Conventional occupational therapy sessions. |
| Experimental Group (EG) | Experimental | Experimental Group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions. Receives: Procedure: Conventional occupational therapy sessions + Nintendo Switch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine Hole Peg Test
This test measures fine manual dexterity. This is considered a "gold standard" to evaluate fine manual dexterity (21). It consists of placing a number of pins on a board with 9 holes and removing them as quickly as possible. This test records the time the person uses with each upper limb.
Measured: Pre-intervention and post-intervention (up to 1 week)
Box and Block Test
Test that measures the gross motor skills of the upper limbs. It consists of a wooden box that is divided into two halves by an axis, and consists of passing from one half to the other as many wooden blocks as possible with each upper limb, for 1 minute. In this test, the number of blocks that the person is able to pass in one minute with each upper limb is recorded.
Measured: Pre-intervention and post-intervention (up to 1 week)
Barthel Index
This scale is used to assess the level of functional independence in the basic activities of daily living that a person presents. In this test, the higher the score, the higher the level of functional independence of the person.
Measured: Pre-intervention and post-intervention (up to 1 week)
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)
Secondary outcomes (1)
The Client Satisfaction Questionnaire-8, CSQ-8
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 posted13 Nov 2023
- Study start1 Mar 2023
- Primary completion15 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Control Group (CG), which received their usual sessions of conventional occupational therapy, and an Experimental Group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 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
- NCT06129630
- Sponsor's protocol ID
- 2702202309423
- Status last verified
- May 2024
- First submitted
- 30 Oct 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06129630
- Acronym / sponsor ID
- 2702202309423
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 13 Nov 2023 (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.
Purpose: Healthy aging is the process of optimizing opportunities for health, participation and safety in order to improve quality of life as people age. This study aimed to provide healthy aging for people with cognitive impairment through the use of the Nintendo Switch combined with Occupational Therapy sessions.
Material and methods: a randomized clinical trial was conducted. The sample was randomized using a software program, OxMar, which allowed the separation of the sample into a control group (CG), which received their usual sessions of conventional occupational therapy, and an experimental group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions. An 8-week intervention was conducted with Nintendo Switch.
Measures: Nine Hole Peg Test, Box and Block Test, Barthel Index, WHOQOL-BREF, CSQ-8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Control Group (CG), which received their usual sessions of conventional occupational therapy, and an Experimental Group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions.
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | Active comparator | Procedure: Conventional occupational therapy sessions.Control Group (CG), which received their usual sessions of conventional occupational therapy. |
| Experimental Group (EG) | Experimental | Procedure: Conventional occupational therapy sessions + Nintendo SwitchExperimental Group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Adult men or women, aged 65 years or older, cohabitating in the nursing home.
- Not presenting moderate or severe cognitive impairment measured through the MEC- Lobo test (score ≥ 24-35) (20).
- Agree to participate voluntarily, having read the project information sheet and signed the informed consent.
Key exclusion criteria (3 listed)
- Presence of neurodegenerative pathology.
- Presence of physical pathology that compromised the person's safety.
- Severe cognitive impairment.
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.Occupational therapy sessions are based on cognitive stimulation, manipulative dexterity training and psychomotor skills. | Procedure or surgery | Control Group (CG) |
| Conventional occupational therapy sessions + Nintendo SwitchOccupational 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) |
Primary outcome
Nine Hole Peg Test
Time frame: Pre-intervention and post-intervention (up to 1 week)
This test measures fine manual dexterity. This is considered a "gold standard" to evaluate fine manual dexterity (21). It consists of placing a number of pins on a board with 9 holes and removing them as quickly as possible. This test records the time the person uses with each upper limb.
Box and Block Test
Time frame: Pre-intervention and post-intervention (up to 1 week)
Test that measures the gross motor skills of the upper limbs. It consists of a wooden box that is divided into two halves by an axis, and consists of passing from one half to the other as many wooden blocks as possible with each upper limb, for 1 minute. In this test, the number of blocks that the person is able to pass in one minute with each upper limb is recorded.
Barthel Index
Time frame: Pre-intervention and post-intervention (up to 1 week)
This scale is used to assess the level of functional independence in the basic activities of daily living that a person presents. In this test, the higher the score, the higher the level of functional independence of the person.
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.
1 secondary outcome
The Client Satisfaction Questionnaire-8, CSQ-8
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 8 May 2024.
- 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. and Conventional occupational therapy sessions + Nintendo Switch in people with Cognitive Impairment and Elderly People, 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 3 inclusion and 3 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 8 May 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?
Nine Hole Peg Test (time frame: Pre-intervention and post-intervention (up to 1 week)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.