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

NCT ID: NCT05143385

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2023-12-31

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.

Conditions

Stroke, Acute; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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.

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: 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:

Interventions

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:

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Carlos, Madrid

OTHER

Sponsor Role: lead

Responsible Party

Patricia Blázquez González

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Blázquez González, Professor

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Fundación Instituto San Jose

Madrid, España, Spain

CEADAC

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 38197947 (View on PubMed)

Other Identifiers

HospitalSanCarlos

Identifier Type: -

Identifier Source: org_study_id