Brain InjuryNSTOCNCT07682688
Effectiveness of Nintendo Switch Combined With Occupational Therapy to Reduce Fall Risk in Patients With Hemiparesis After Acquired Brain Injury
A study testing Nintendo Switch Exergaming Combined With Occupational Therapy and Conventional in people with Brain Injury and Ictus, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Title: Effectiveness of Mixed Reality Combined with Occupational Therapy to Reduce Fall Risk in Patients with Hemiparesis After Acquired Brain Injury Study Purpose: This study aims to test whether adding Nintendo Switch video game exercises to regular occupational therapy helps adults with hemipareasia after brain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Ictus
- What is being tested?
- Nintendo Switch Exergaming Combined With Occupational Therapy and Conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2025to 26 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals older than 18 years of age
- Present hemiparesia as a consequence of acquired brain injury with clinical evidence of persistent motor deficit
- Regularly attend rehabilitation treatment at Polibea Norte
- Have ability to walk with or without technical aids
- Present score between 14 and 22 on the Mini-BESTest test
- Have ability to understand simple instructions and follow the intervention
- Voluntarily accept participation and sign informed consent
Who cannot join
- Present severe cognitive deficit or global aphasia preventing understanding of tasks and risks of the intervention
- Present uncontrolled convulsive episodes or severe visual impairment preventing intervention with visual devices
- Present vestibular disorders
- Participating in other similar intervention programs during the same period
- Not accepting voluntary participation in the study and/or not signing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Title: Effectiveness of Mixed Reality Combined with Occupational Therapy to Reduce Fall Risk in Patients with Hemiparesis After Acquired Brain Injury Study Purpose: This study aims to test whether adding Nintendo Switch video game exercises to regular occupational therapy helps adults with hemipareasia after brain injury. The main goals are to reduce fall risk, improve balance, and enhace quality of life and motivation during rehabilitation.
Study Design: This is a pilot randomized controlled trial. The study will run for 5 months at Polibea Norte Rehabilitation Center for Brain Injury in Madrid, Spain.
Read more
Participants: Adults over 18 years old with hemiparesia from stroke or brain injury who can walk and have mild to moderate balance problems.
Groups: Participants will be randomly assigned to one of two groups:
Control Group: Receives usual occupational therapy (2 sessions per week, 1 hour each) Experimental Group: Receives 30 minutes of occupational therapy plus 30 minutes of Nintendo Switch exercises (2 sessions per week, 1 hour total) for 8 weeks The Nintendo Switch sessions use Ring Fit Adventure and Nintendo Switch Sports games that require standing, balancing, reaching, and moving different body parts. A therapist supervises all sessions.
Before and after the 8-week intervention, all participants will be assessed on:
Fall risk and balance: Using standardized tests including the Tinetti Scale, Timed Up and Go test, and Functional Reach Test Functional independence: Using the Functional Independence Measure (FIM) Quality of life: Using the WHOQOL-BREF questionnaire Satisfaction with treatment: Using the Client Satisfaction Questionnaire (CSQ-8) This study will provide preliminary information about whether Nintendo Switch can be a useful tool for rehabilitation of adults with hemiparesia after brain injury. If the intervention proves feasible and shows positive effects, it could be developed into a larger study and potentially used in clinical practice as a complement to traditional therapy. The engaging nature of video games might improve motivation and adherence to rehabilitation, which are important factors for recovery.
- Conditions
- Brain Injury, Ictus
- Being tested
- Nintendo Switch Exergaming Combined With Occupational Therapy, Conventional
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Switch Exergaming Combined With Occupational TherapyOther
This study tests a novel rehabilitation approach combining Nintendo Switch active video gaming (exergaming) with conventional occupational therapy for adults with hemiparesia following stroke or acquired brain injury. The intervention uses commercially available Nintendo Switch console and games requiring full-body movement to target balance, postural control, strength, and coordination.
The intervention is 30 minutes Nintendo Switch + 30 minutes conventional occupational therapy per session, twice weekly. This differs from:
Pure exergame interventions where gaming replaces traditional therapy Technology-only approaches without conventional therapy Home-based unsupervised programs without therapist supervision Sessions are supervised by licensed occupational therapists who adjust difficulty, provide cues and assistance, ensure safety and proper movement patterns, and integrate gaming with conventional therapy goals.
ConventionalOther
Participants receive standard occupational therapy sesions
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control grpup receives conventional occupational therapy only Receives: Other: Conventional |
| Experimental Group | Experimental | The experimental group recceives treatment with Nintendo Switch plus conventional occupational therapy. Receives: Other: Nintendo Switch Exergaming Combined With Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Risk (Tinetti Scale)
The Tinetti Scale assesses balance and gait to estimate fall risk. Includes two sections: balance (maximum 16 points) and gait (maximum 12 points), totaling 28 points. Higher score indicates lower fall risk. Administered through direct observation.
Measured: Baseline (pre-intervention) and after 8 weeks (post-intervention, up to 1 week)
Secondary outcomes (5)
Gait Speed and Balance (Timed Up and Go Test - TUG)
Measures time to stand from chair, walk 3 meters, turn, return, and sit down. Assesses balance and gait speed. Recorded in seconds. Lower time indicates better performance.
Measured: Baseline (pre-intervention) and post-intervention (up to 1 week)
Dynamic Balance (Functional Reach Test - FRT)
Measures maximum distance individual can move center of gravity toward limits of base of support while standing. Participant flexes shoulders to 90 degrees with extended hand and moves forward as far as possible while maintaining balance. Recorded in centimeters. Greater distance indicates better dynamic balance.
Measured: Baseline (pre-intervention) and post-intervention (up to 1 week)
Functional Independence (Functional Independence Measure - FIM)
Instrument measuring level of functional independence in activities of daily living through 18 items covering motor and cognitive performance. Score ranges 1-7 per item, with higher score indicating greater independence. Administered through observation and interview.
Measured: Baseline (pre-intervention) and post-intervention (up to 1 week)
Quality of Life (WHOQOL-BREF)
Self-administered questionnaire evaluating general perception of quality of life and global health status. Contains four domains: physical health, psychological health, social relationships, and environment. Higher score indicates better quality of life.
Measured: Baseline (pre-intervention) and post-intervention (up to 1 week)
Treatment Satisfaction (Client Satisfaction Questionnaire - CSQ-8)
Self-administered questionnaire with 8 questions evaluating satisfaction level with care and quality of service received, plus fulfillment of patient expectations prior to intervention. Responses coded 1-4, total score 32 points. Higher score indicates greater satisfaction with treatment.
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 posted6 Jul 2026
- Study start12 Dec 2025
- Primary completion20 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Gil Manglano, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682688
- Sponsor's protocol ID
- 031220250082026
- Acronym
- NSTOC
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nintendo Switch Combined With Occupational Therapy to Reduce Fall Risk in Patients With Hemiparesis After Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT07682688
- Acronym / sponsor ID
- NSTOC / 031220250082026
- Conditions
- Brain Injury, Ictus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 6 Jul 2026 (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.
Title: Effectiveness of Mixed Reality Combined with Occupational Therapy to Reduce Fall Risk in Patients with Hemiparesis After Acquired Brain Injury Study Purpose: This study aims to test whether adding Nintendo Switch video game exercises to regular occupational therapy helps adults with hemipareasia after brain injury. The main goals are to reduce fall risk, improve balance, and enhace quality of life and motivation during rehabilitation.
Study Design: This is a pilot randomized controlled trial. The study will run for 5 months at Polibea Norte Rehabilitation Center for Brain Injury in Madrid, Spain.
Participants: Adults over 18 years old with hemiparesia from stroke or brain injury who can walk and have mild to moderate balance problems.
Groups: Participants will be randomly assigned to one of two groups:
Control Group: Receives usual occupational therapy (2 sessions per week, 1 hour each) Experimental Group: Receives 30 minutes of occupational therapy plus 30 minutes of Nintendo Switch exercises (2 sessions per week, 1 hour total) for 8 weeks The Nintendo Switch sessions use Ring Fit Adventure and Nintendo Switch Sports games that require standing, balancing, reaching, and moving different body parts. A therapist supervises all sessions.
Before and after the 8-week intervention, all participants will be assessed on:
Fall risk and balance: Using standardized tests including the Tinetti Scale, Timed Up and Go test, and Functional Reach Test Functional independence: Using the Functional Independence Measure (FIM) Quality of life: Using the WHOQOL-BREF questionnaire Satisfaction with treatment: Using the Client Satisfaction Questionnaire (CSQ-8) This study will provide preliminary information about whether Nintendo Switch can be a useful tool for rehabilitation of adults with hemiparesia after brain injury. If the intervention proves feasible and shows positive effects, it could be developed into a larger study and potentially used in clinical practice as a complement to traditional therapy. The engaging nature of video games might improve motivation and adherence to rehabilitation, which are important factors for recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: ConventionalThe control grpup receives conventional occupational therapy only |
| Experimental Group | Experimental | Other: Nintendo Switch Exergaming Combined With Occupational TherapyThe experimental group recceives treatment with Nintendo Switch plus conventional occupational therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals older than 18 years of age
- Present hemiparesia as a consequence of acquired brain injury with clinical evidence of persistent motor deficit
- Regularly attend rehabilitation treatment at Polibea Norte
- Have ability to walk with or without technical aids
- Present score between 14 and 22 on the Mini-BESTest test
Key exclusion criteria (5 listed)
- Present severe cognitive deficit or global aphasia preventing understanding of tasks and risks of the intervention
- Present uncontrolled convulsive episodes or severe visual impairment preventing intervention with visual devices
- Present vestibular disorders
- Participating in other similar intervention programs during the same period
- Not accepting voluntary participation in the study and/or not signing informed consent
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 |
|---|---|---|
| Nintendo Switch Exergaming Combined With Occupational TherapyThis study tests a novel rehabilitation approach combining Nintendo Switch active video gaming (exergaming) with conventional occupational therapy for adults with hemiparesia following stroke or acquired brain injury. The intervention uses commercially available Nintendo Switch console and games requiring full-body movement to target balance, postural control, strength, and coordination. The intervention is 30 minutes Nintendo Switch + 30 minutes conventional occupational therapy per session, twice weekly. This differs from: Pure exergame interventions where gaming replaces traditional therapy Technology-only approaches without conventional therapy Home-based unsupervised programs without therapist supervision Sessions are supervised by licensed occupational therapists who adjust difficulty, provide cues and assistance, ensure safety and proper movement patterns, and integrate gaming with conventional therapy goals. | Other | Experimental Group |
| ConventionalParticipants receive standard occupational therapy sesions | Other | Control Group |
Primary outcome
Fall Risk (Tinetti Scale)
Time frame: Baseline (pre-intervention) and after 8 weeks (post-intervention, up to 1 week)
The Tinetti Scale assesses balance and gait to estimate fall risk. Includes two sections: balance (maximum 16 points) and gait (maximum 12 points), totaling 28 points. Higher score indicates lower fall risk. Administered through direct observation.
5 secondary outcomes
Gait Speed and Balance (Timed Up and Go Test - TUG)
Time frame: Baseline (pre-intervention) and post-intervention (up to 1 week)
Dynamic Balance (Functional Reach Test - FRT)
Time frame: Baseline (pre-intervention) and post-intervention (up to 1 week)
Functional Independence (Functional Independence Measure - FIM)
Time frame: Baseline (pre-intervention) and post-intervention (up to 1 week)
Quality of Life (WHOQOL-BREF)
Time frame: Baseline (pre-intervention) and post-intervention (up to 1 week)
Treatment Satisfaction (Client Satisfaction Questionnaire - 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 6 Jul 2026.
- 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 Nintendo Switch Exergaming Combined With Occupational Therapy and Conventional in people with Brain Injury and Ictus, 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 7 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 6 Jul 2026. 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?
Fall Risk (Tinetti Scale) (time frame: Baseline (pre-intervention) and after 8 weeks (post-intervention, up to 1 week)). 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 6 Jul 2026.