Occupational TherapyNCT06285877
Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury
A study testing Conventional therapy sessions and Conventional therapy sessions plus Nintendo Switch in people with Occupational Therapy and Acquired Brain Injury, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Purpose: to observe the possible benefits produced by conventional therapy through virtual reality with the Nintendo Switch to try to improve motivation and increase the degree of care satisfaction. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Occupational Therapy, Acquired Brain Injury, Adults
- What is being tested?
- Conventional therapy sessions and Conventional therapy sessions plus 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
- Feb 2024to Jan 2025
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women, over 30 years of age who have suffered an acquired brain injury.
- Mild or moderate cognitive impairment as measured by the MEC-Lobo test (score greater than 23/35).
- Regularly attend some conventional therapy (neuropsychology, physiotherapy or occupational therapy).
- Agree to participate voluntarily by signing the informed consent form.
Who cannot join
- Present severe cognitive impairment as measured by the MEC-Lobo test (less than 23/35).
- Present aphasia of comprehension or expression.
- Present associated neurodegenerative pathology.
- Present any pathology underlying the acquired brain damage (diabetes, heart disease, COPD, etc.), heart disease, COPD, etc.).
- Voluntarily refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Rey Juan Carlos
Móstoles, Madrid, 28933
Isabel Quirosa Galan, MsC, +34655551210, i.quirosa.2016@alumnos.urjc.es
About this study
Official title: Study on the Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury: A Pilot Study
Purpose: to observe the possible benefits produced by conventional therapy through virtual reality with the Nintendo Switch to try to improve motivation and increase the degree of care satisfaction. The aim is to improve postural control in both seated and standing positions and to maintain and improve cognitive capacity.
Material and methods: one group (experimental group) will receive a total of 8 one-hour sessions or 16 half-hour sessions, depending on their individual needs, for 8 weeks using the Nintendo Switch. The other group (control group) will continue to receive their conventional scheduled therapy.
Measures: Abilhand, MEC-Lobo, FIST, Fugl-Meyer, Berg Balance Scale and CSQ-8.
- Conditions
- Occupational Therapy, Acquired Brain Injury, Adults
- Being tested
- Conventional therapy sessions, Conventional therapy sessions plus Nintendo Switch
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapy sessionsProcedure or surgery
Conventional sessions are neuropsychology, speech therapy, physiotherapy and occupational therapy treatments. They are based on cognitive stimulation, manipulative dexterity, therapeutic exercise.
Conventional therapy sessions plus Nintendo SwitchProcedure or surgery
Conventional sessions are neuropsychology, speech therapy, physiotherapy and occupational therapy treatments. They are based on cognitive stimulation, manipulative dexterity, therapeutic exercise plus one hour a week of Nintendo Switch.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Control Group (CG) which received their usual sessions of conventional therapy. Receives: Procedure: Conventional therapy sessions |
| Experimental Group | Experimental | Experimental Group (EG) which received therapy with Nintendo Switch plus their usual sessions of conventional therapy. Receives: Procedure: Conventional therapy sessions plus Nintendo Switch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abilhand
It is an assessment test that measures the degree of difficulty perceived by the patient in performing the 23 activities of daily living.
Measured: Pre-intervention and post-intervention (up to 1-2 weeks)
MEC-Lobo
This is a scale that allows us to evaluate the cognitive status of patients. The lower the score, the greater the cognitive impairment.
Measured: Pre-intervention and post-intervention (up to 1-2 weeks)
Function in Sitting Test (FIST)
It is a scale that assesses the postural control deficits presented by the patient in sedentary position in the event of imbalance, reaching on the floor, etc.
Measured: Pre-intervention and post-intervention (up to 1-2 weeks)
Fugl-Meyer
This scale assesses the patient's motor function, sensory function, muscle balance, range of joint mobility and joint pain.
Measured: Pre-intervention and post-intervention (up to 1-2 weeks)
Berg Balance Scale (BBS)
The scale is used to measure balance mainly in standing position in patients with different types of pathologies.
Measured: Pre-intervention and post-intervention (up to 1-2 weeks)
Secondary outcomes (1)
Client Satisfaction Questionnaire (CSQ-8)
Self-administered questionnaire that evaluates the level of satisfaction in relation to the care and quality of care received.
Measured: Post-intervention (up to 1-2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational TherapyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Control Group (CG), which received their usual sessions of conventional therapy sessions, and an Experimental Group (EG), which received therapy with Nintendo Switch plus their conventional therapy sessions.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Quirosa Galan, Universidad Rey Juan Carlos
- Investigators
- Isabel Quirosa Galan, MsC, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285877
- Sponsor's protocol ID
- 291120234382023
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT06285877
- Acronym / sponsor ID
- 291120234382023
- Conditions
- Occupational Therapy, Acquired Brain Injury, Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 29 Feb 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.
Purpose: to observe the possible benefits produced by conventional therapy through virtual reality with the Nintendo Switch to try to improve motivation and increase the degree of care satisfaction. The aim is to improve postural control in both seated and standing positions and to maintain and improve cognitive capacity.
Material and methods: one group (experimental group) will receive a total of 8 one-hour sessions or 16 half-hour sessions, depending on their individual needs, for 8 weeks using the Nintendo Switch. The other group (control group) will continue to receive their conventional scheduled therapy.
Measures: Abilhand, MEC-Lobo, FIST, Fugl-Meyer, Berg Balance Scale and CSQ-8.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control Group (CG), which received their usual sessions of conventional therapy sessions, and an Experimental Group (EG), which received therapy with Nintendo Switch plus their conventional therapy sessions.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Conventional therapy sessionsControl Group (CG) which received their usual sessions of conventional therapy. |
| Experimental Group | Experimental | Procedure: Conventional therapy sessions plus Nintendo SwitchExperimental Group (EG) which received therapy with Nintendo Switch plus their usual sessions of conventional therapy. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult men and women, over 30 years of age who have suffered an acquired brain injury.
- Mild or moderate cognitive impairment as measured by the MEC-Lobo test (score greater than 23/35).
- Regularly attend some conventional therapy (neuropsychology, physiotherapy or occupational therapy).
- Agree to participate voluntarily by signing the informed consent form.
Key exclusion criteria (5 listed)
- Present severe cognitive impairment as measured by the MEC-Lobo test (less than 23/35).
- Present aphasia of comprehension or expression.
- Present associated neurodegenerative pathology.
- Present any pathology underlying the acquired brain damage (diabetes, heart disease, COPD, etc.), heart disease, COPD, etc.).
- Voluntarily refuse to participate 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 therapy sessionsConventional sessions are neuropsychology, speech therapy, physiotherapy and occupational therapy treatments. They are based on cognitive stimulation, manipulative dexterity, therapeutic exercise. | Procedure or surgery | Control Group |
| Conventional therapy sessions plus Nintendo SwitchConventional sessions are neuropsychology, speech therapy, physiotherapy and occupational therapy treatments. They are based on cognitive stimulation, manipulative dexterity, therapeutic exercise plus one hour a week of Nintendo Switch. | Procedure or surgery | Experimental Group |
Primary outcome
Abilhand
Time frame: Pre-intervention and post-intervention (up to 1-2 weeks)
It is an assessment test that measures the degree of difficulty perceived by the patient in performing the 23 activities of daily living.
MEC-Lobo
Time frame: Pre-intervention and post-intervention (up to 1-2 weeks)
This is a scale that allows us to evaluate the cognitive status of patients. The lower the score, the greater the cognitive impairment.
Function in Sitting Test (FIST)
Time frame: Pre-intervention and post-intervention (up to 1-2 weeks)
It is a scale that assesses the postural control deficits presented by the patient in sedentary position in the event of imbalance, reaching on the floor, etc.
Fugl-Meyer
Time frame: Pre-intervention and post-intervention (up to 1-2 weeks)
This scale assesses the patient's motor function, sensory function, muscle balance, range of joint mobility and joint pain.
Berg Balance Scale (BBS)
Time frame: Pre-intervention and post-intervention (up to 1-2 weeks)
The scale is used to measure balance mainly in standing position in patients with different types of pathologies.
1 secondary outcome
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-intervention (up to 1-2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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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.
Isabel Quirosa Galan, MsC principal investigator
Universidad Rey Juan Carlos
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 therapy sessions and Conventional therapy sessions plus Nintendo Switch in people with Occupational Therapy and Acquired Brain Injury, 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 4 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: status not confirmed, as of the sponsor's last update on 29 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel Quirosa Galan, MsC (+34655551210, i.quirosa.2016@alumnos.urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abilhand (time frame: Pre-intervention and post-intervention (up to 1-2 weeks)). The study lists 5 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 29 Feb 2024.