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

NCT05143385 | Unknown

• 1 other identifier: HospitalSanCarlos
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke, Acute; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Mississippi Aphasia Screening Test

  5-10 minutes

• Barthel Scale

  2 minutes

• Canadian neurological scale

  10 minutes

• Subjective social support scale (Duke-UNK-11)

  8 minutes

• UCLA loneliness scale

  10 minutes

Other Outcomes (1)

• European Health Literacy Survey Questionnaire (HLS-EU Q16)

  5 minutes

Study Arms (2)

Control

NO INTERVENTION

The variables to be filled in upon admission are: age, sex, reason for admission and main caregiver. The variables that will be collected on admission and discharge are: Mississippi Aphasia Screening test, Canadian scale, Duke-UNK-11 subjective support scale, UCLA loneliness scale, oropharyngeal dysphagia screening test, Pfreiffer scale, State assessment mood, Hamilton Rating for Depression and Hospital Anxiety Depression Scale and HLS-EU Q16., Will be performed on all patients who are part of the trial. Those patients where conventional rehabilitative treatment is performed will be: * Physiotherapy sessions * Speech therapy sessions * Neuropsychology sessions * Occupational therapy sessions

Intervention Group

EXPERIMENTAL

The variables are to be filled in upon admission are: age, sex, reason for admission and main caregiver. The variables that will be collected on admission and discharge are: MAST, Canadian scale, Duke-UNK-11 subjective support scale, UCLA loneliness scale, oropharyngeal dysphagia screening test, Pfeiffer scale, State assessment mood, Hamilton Rating for Depression and Hospital Anxiety Depression Scale and HLS-EU Q16.The beginning of the intervention will be once you have completed 15 calendar days from your admission.The intervention will be carried out once a week with a duration of 20 min with one of the games chosen by the patient together with the physiotherapist.The completion of the intervention will be until the patient is discharged from hospital, with a minimum of four sessions carried out in order to participate in the study.A registration table will be executed where the number of sessions of each patient and the type of session are quantified like a control group.

Other: Virtual reality

Interventions

Virtual reality OTHER

* 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:

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (2)

Fundación Instituto San Jose

Madrid, España, 28054, Spain

Location

CEADAC

Madrid, 28034, Spain

Location

Related Publications (1)

• Blazquez-Gonzalez P, Miron-Gonzalez R, Lendinez-Mesa A, Luengo-Gonzalez R, Mancebo-Salas N, Camacho-Arroyo MT, Muriel-Garcia A, Garcia-Sastre MM. Efficacy of the use of video games on mood, anxiety and depression in stroke patients: preliminary findings of a randomised controlled trial. J Neurol. 2024 Mar;271(3):1224-1234. doi: 10.1007/s00415-023-12043-z. Epub 2024 Jan 10.

  PMID: 38197947 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Patricia Blázquez González, Professor

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: \- As an open-label clinical trial, the allocation to each group is known. The possibility of blinding is not contemplated. Blinded third-party assessment will be carried out, as a third party will be used who will not know which treatment each patient is receiving.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: RANDOMISED CLINICAL TRIAL

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: December 3, 2021
• Study Start: October 11, 2021
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)