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

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285877
• Other study ID #: 291120234382023
• Status: Recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Universidad Rey Juan Carlos
• Contact: Isabel Quirosa Galan, MsC
• Phone: +34655551210
• Email: i.quirosa.2016[@]alumnos.urjc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: January 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Adults
• Brain Injuries
• Occupational Therapy
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Móstoles	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)