Clinical trial NCT05143385: Efficacy of Recreational-therapeutic Use of Video Games on the Emotional State of Stroke Patients
Official title: Randomized Clinical Trial: Efficacy of Recreational-therapeutic Use of Video Games on the Emotional State of Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke, Acute
Virtual Reality
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMISED CLINICAL TRIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: According to the latest published literature reviews, stroke patients have a prevalence of 19.5% of minor depression and 21.7% of major depression. Furthermore, the loss of autonomy is the most strongly correlated variable in these emotional disorders. In addition, emotional disturbances - in particular anxiety, sadness, crying, and anhedonia - are interpreted as natural reactions to the loss of physical capacity. Along these lines, it has been shown that the use of Virtual Reality (VR) as a co-adjuvant therapy of neuro-rehabilitation in stroke patients with emotional disorders decreases the incidence of these disorders.

Detailed description: . Primary objective

- To evaluate the impact on mood, anxiety and depression in patients admitted to neurorehabilitation units after the use of non-immersive virtual reality with the Nintento Switch device in their rehabilitation treatment.

Secondary objectives

* To describe the emotional state of patients before the use of non-immersive virtual therapy in their rehabilitation.
* To describe the emotional state of patients after the use of virtual reality in their rehabilitation.
* To compare the emotional state of patients before and after the implementation of virtual therapy in their rehabilitation.
* To describe the emotional state of patients who have not used non-immersive virtual reality in their rehabilitation by choice.
* To evaluate the efficacy of the involvement of the use of virtual reality therapy in patients with altered emotional state.

Eligibility criteria: Inclusion Criteria:

* To be of legal age
* Fluent in oral and written Spanish.
* Patients with cognitive functions of expression and comprehension.

Exclusion Criteria:

* Patients who are not undergoing neurorehabilitation treatment.
* Patients who have not yet started rehabilitation treatment.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 10 minutes
measure: Hamilton Rating for Depression
timeFrame: 10 minutes
measure: Mood Assessment Scale
timeFrame: 2 minutes
Secondary outcomes:
measure: Mississippi Aphasia Screening Test
timeFrame: 5-10 minutes
measure: Barthel Scale
timeFrame: 2 minutes
measure: Canadian neurological scale
timeFrame: 10 minutes
measure: Subjective social support scale (Duke-UNK-11)
timeFrame: 8 minutes
measure: UCLA loneliness scale
timeFrame: 10 minutes
measure: Pfeiffer scale
timeFrame: 10minutes
Other outcomes:
measure: European Health Literacy Survey Questionnaire (HLS-EU Q16)
timeFrame: 5 minutes
Locations:
city: Madrid
country: Spain
facility: Fundación Instituto San Jose
state: España
city: Madrid
country: Spain
facility: CEADAC
Study officials:
affiliation: Professor
name: Patricia Blázquez González, Professor
role: PRINCIPAL_INVESTIGATOR
References: