- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07682688
Effectiveness of Nintendo Switch Combined With Occupational Therapy to Reduce Fall Risk in Patients With Hemiparesis After Acquired Brain Injury (NSTOC)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
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Madrid, Madrid, Spain
- Polibea Norte
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
The control grpup receives conventional occupational therapy only
|
Participants receive standard occupational therapy sesions
|
|
Experimental: Experimental Group
The experimental group recceives treatment with Nintendo Switch plus conventional occupational therapy.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (pre-intervention) and after 8 weeks (post-intervention, up to 1 week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Speed and Balance (Timed Up and Go Test - TUG)
Time Frame: Baseline (pre-intervention) and post-intervention (up to 1 week)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)]
|
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.
|
Post-intervention (up to 1 week)]
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Therapeutics
- Patient Care
- Organizations
- Health Care Economics and Organizations
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Congresses as Topic
- Occupational Therapy
Other Study ID Numbers
- 031220250082026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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