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

Study on the Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury: A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Acquired Brain Injury; Occupational Therapy; Adults
• Intervention / Treatment: Procedure: Conventional therapy sessions; Procedure: Conventional therapy sessions plus Nintendo Switch

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabel Quirosa Galan, MsC; Phone Number: +34655551210; Email: i.quirosa.2016@alumnos.urjc.es

Study Locations

• Spain
  • Madrid
    • Móstoles, Madrid, Spain, 28933
      • Recruiting
      • Universidad Rey Juan Carlos
      • Contact: Isabel Quirosa Galan, MsC; Phone Number: +34655551210; Email: i.quirosa.2016@alumnos.urjc.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Control Group (CG) which received their usual sessions of conventional therapy.	Procedure: Conventional therapy sessions; Conventional sessions are neuropsychology, speech therapy, physiotherapy and occupational therapy treatments. They are based on cognitive stimulation, manipulative dexterity, therapeutic exercise.
Experimental: Experimental Group; Experimental Group (EG) which received therapy with Nintendo Switch plus their usual sessions of conventional therapy.	Procedure: Conventional therapy sessions plus Nintendo Switch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire (CSQ-8)	Self-administered questionnaire that evaluates the level of satisfaction in relation to the care and quality of care received.	Post-intervention (up to 1-2 weeks)

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: Isabel Quirosa Galan, MsC, Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: 291120234382023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No