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Completed

NCT Number: NCT07682688

Effectiveness of Nintendo Switch Combined With Occupational Therapy to Reduce Fall Risk in Patients With Hemiparesis After Acquired Brain Injury

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.

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Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Ictus Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polibea Norte

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nintendo Switch Exergaming Combined With Occupational Therapy

Other

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.

Conventional

Other

Participants receive standard occupational therapy sesions

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Acronym: NSTOC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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