Back to resultsEfficacy of Recreational-therapeutic Use of Video Games on the Emotional State of Stroke Patients
Primary Purpose
Stroke, Acute, Virtual Reality
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke, Acute
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.
Sites / Locations
- Fundación Instituto San Jose
- CEADAC
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention Group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
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).
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.
Secondary Outcome Measures
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.
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.
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).
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.
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.
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).
Full Information
NCT ID
NCT05143385
First Posted
October 14, 2021
Last Updated
August 17, 2023
Sponsor
Hospital San Carlos, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT05143385
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Virtual Reality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMISED CLINICAL TRIAL
Masking
None (Open Label)
Masking Description
- 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.
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
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:
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
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
Time Frame
10 minutes
Title
Hamilton Rating for Depression
Description
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).
Time Frame
10 minutes
Title
Mood Assessment Scale
Description
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.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Mississippi Aphasia Screening Test
Description
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.
Time Frame
5-10 minutes
Title
Barthel Scale
Description
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.
Time Frame
2 minutes
Title
Canadian neurological scale
Description
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).
Time Frame
10 minutes
Title
Subjective social support scale (Duke-UNK-11)
Description
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.
Time Frame
8 minutes
Title
UCLA loneliness scale
Description
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.
Time Frame
10 minutes
Title
Pfeiffer scale
Description
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).
Time Frame
10minutes
Other Pre-specified Outcome Measures:
Title
European Health Literacy Survey Questionnaire (HLS-EU Q16)
Description
Measurement of literacy
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Blázquez González, Professor
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Instituto San Jose
City
Madrid
State/Province
España
ZIP/Postal Code
28054
Country
Spain
Facility Name
CEADAC
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study results
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Efficacy of Recreational-therapeutic Use of Video Games on the Emotional State of Stroke Patients
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