Clinical trial NCT06285877: Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Occupational Therapy
Acquired Brain Injury
Adults
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Abilhand
timeFrame: Pre-intervention and post-intervention (up to 1-2 weeks)
measure: MEC-Lobo
timeFrame: Pre-intervention and post-intervention (up to 1-2 weeks)
measure: Function in Sitting Test (FIST)
timeFrame: Pre-intervention and post-intervention (up to 1-2 weeks)
measure: Fugl-Meyer
timeFrame: Pre-intervention and post-intervention (up to 1-2 weeks)
measure: Berg Balance Scale (BBS)
timeFrame: Pre-intervention and post-intervention (up to 1-2 weeks)
Secondary outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-intervention (up to 1-2 weeks)
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Isabel Quirosa Galan, MsC
role: PRINCIPAL_INVESTIGATOR
References: