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

NCT07682688 | Completed

• 1 other identifier: 031220250082026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Brain Injury; Ictus

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline (pre-intervention) and post-intervention (up to 1 week)

• Dynamic Balance (Functional Reach Test - FRT)

  Baseline (pre-intervention) and post-intervention (up to 1 week)

• Functional Independence (Functional Independence Measure - FIM)

  Baseline (pre-intervention) and post-intervention (up to 1 week)

• Quality of Life (WHOQOL-BREF)

  Baseline (pre-intervention) and post-intervention (up to 1 week)

• Treatment Satisfaction (Client Satisfaction Questionnaire - CSQ-8)

  Post-intervention (up to 1 week)]

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The control grpup receives conventional occupational therapy only

Other: Conventional

Experimental Group

EXPERIMENTAL

The experimental group recceives treatment with Nintendo Switch plus conventional occupational therapy.

Other: Nintendo Switch Exergaming Combined With Occupational Therapy

Interventions

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.

Experimental Group

Conventional OTHER

Participants receive standard occupational therapy sesions

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Polibea Norte

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Occupational Therapy; Congresses as Topic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start: December 12, 2025
• Primary Completion: June 20, 2026
• Study Completion: June 26, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)