Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury

NCT06285877 | Recruiting

• 1 other identifier: 291120234382023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (5)

• Abilhand

  It is an assessment test that measures the degree of difficulty perceived by the patient in performing the 23 activities of daily living.

  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.

  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.

  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.

  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.

  Pre-intervention and post-intervention (up to 1-2 weeks)

Secondary Outcomes (1)

• Client Satisfaction Questionnaire (CSQ-8)

  Post-intervention (up to 1-2 weeks)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Control Group (CG) which received their usual sessions of conventional therapy.

Procedure: Conventional therapy sessions

Experimental Group

EXPERIMENTAL

Experimental Group (EG) which received therapy with Nintendo Switch plus their usual sessions of conventional therapy.

Procedure: Conventional therapy sessions plus Nintendo Switch

Interventions

Conventional therapy sessions PROCEDURE

Conventional sessions are neuropsychology, speech therapy, physiotherapy and occupational therapy treatments. They are based on cognitive stimulation, manipulative dexterity, therapeutic exercise.

Control Group

Conventional therapy sessions plus Nintendo Switch PROCEDURE

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.

Experimental Group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Isabel Quirosa Galan, MsC

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Quirosa Galan, MsC

CONTACT

+34655551210; i.quirosa.2016@alumnos.urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist, MsC

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 29, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

ES (1)