Efficacy of Recreational-therapeutic Use of Video Games on the Emotional State of Stroke Patients

Stroke, Acute Clinical Trial

Official title:

Randomized Clinical Trial: Efficacy of Recreational-therapeutic Use of Video Games on the Emotional State of Stroke Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05143385
• Other study ID #: HospitalSanCarlos
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: December 31, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute
• Virtual Reality

Intervention

Other:
• Virtual reality
Those patients who are randomly assigned as the intervention group will be given an explanatory session on the use of the video game console, controllers and game accessories. The intervention will begin 15 calendar days after admission. The intervention will be carried out once a week with a duration of 20 minutes with one of the games chosen by the patient together with the physiotherapist. The end of the intervention will be until the patient is discharged from hospital, with a minimum of four sessions completed in order to participate in the study. The intervention will be carried out with an average of six sessions in each patient, including in the study those who perform a minimum of four sessions. However, the interventions will continue until hospital discharge. After completion of the clinical trial, a registry table will be drawn up quantifying the number of sessions for each patient and the type of session:

Locations

Country	Name	City	State
Spain	CEADAC	Madrid
Spain	Fundación Instituto San Jose	Madrid	España

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	European Health Literacy Survey Questionnaire (HLS-EU Q16)	Measurement of literacy	5 minutes
Primary	Hospital Anxiety and Depression Scale	Each has between three and five possible answers, with a score of 0-2 or 0-4 respectively. The total score ranges from 0 to 52. They can use different cut-off points when classifying the depressive picture. The Clinical Practice Guide prepared by NICE [6], a guide with a high overall quality in its preparation and a score of "highly recommended" according to the AGREE instrument, use the following cut-off points: Not depressed: 0-7 Mild / minor depression: 8-13 Moderate depression: 14-18 Severe depression: 19-22 Very severe depression:> 23	10 minutes
Primary	Hamilton Rating for Depression	to assess the intensity or severity of depression in patients already diagnosed in an estimated time of 10 minutes. Quantitatively assess the severity of symptoms and possible changes. Its original version consists of 21 items and its reduced version 17 items.This scale consists of different questions with 3 and 5 possible answers and which are scored with 0-2 or 0-4, their maximum score is 0-52. Possible outcomes are: not depressed (0-7 points), mild / minor depression (8-13 points), moderate depression (14-18 points), severe depression (19-22 points) and very severe depression (> 23 points (66.67).	10 minutes
Primary	Mood Assessment Scale	Each item is valued from 0 to 10 points depending on the value chosen by the person, after directly adding the score of the four adjectives corresponding to each subscale and dividing the sum by 4, four scores between 0 and 10 are obtained that quantify the states sad-depressive, anxious, happy and angry-hostile mood of the person checked at the time the scale was performed.	2 minutes
Secondary	Mississippi Aphasia Screening Test	The linguistic alterations that occur are the language disorders after the stroke are frequent and include aphasia, alexia, agraphy and calculations, for their detection this scale will be used.	5-10 minutes
Secondary	Barthel Scale	Measures the level of functional independence with neuromuscular and / or neuromusculoskeletal diseases, extending its use in assessing the degree 35; development of ABVD, as a prognostic indicator and allocation method of resources. Maximum score: 100 points (90 if you are in a wheelchair) <20 points: total dependence. 40-55 points: moderate dependence. 100 points: independence. 20-35 points: severe dependence.; = 60 points: level of dependency.	2 minutes
Secondary	Canadian neurological scale	neurological rating scale that assesses consciousness (alert and response score 3, clouded score 1.5), language (normal score 1, expressive language deficit 0.5, receptive language deficit 0) and orientation (oriented score 1 and disoriented score 0). The lower the score, the more affected (scale from 1.5 to 10 points).	10 minutes
Secondary	Subjective social support scale (Duke-UNK-11)	It qualitatively evaluates perceived social support. On the one hand, the possibility of having people to communicate is scored and, on the other hand, affective support is evaluated. It consists of 11 items, with Likert-type responses where 1 represents much less than I want and 5 represents as much as I want it. The score varies between 11 and 55, with a score of less than 32 corresponding to low perceived social support, a score of less than 20 indicates a severe degree of loneliness and a score between 20-30 indicates a moderate degree of loneliness.	8 minutes
Secondary	UCLA loneliness scale	measures the feeling of loneliness, consists of three dimensions; subjective perception of loneliness, family support and social support, with two factors, intimacy with others and sociability. It consists of 10 questions that are given a score between 10 and 4 points, with the minimum score of 10 and the maximum of 40. Scores below 20 identify a severe degree of loneliness and, situations between 20-30 indicate a moderate degree of loneliness.	10 minutes
Secondary	Pfeiffer scale	It has 10 items that assess various functions: orientation, recall memory, concentration and calculation.; Ordinal qualitative variable, measured by the classification of cognitive impairment carried out by the Pfeiffer Scale (preserved mental state, mild cognitive impairment, moderate cognitive impairment, and severe cognitive impairment).	10minutes