An interventional study of Virtual reality in Stroke, Acute and Virtual Reality, sponsored by Hospital San Carlos, Madrid. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Hospital San Carlos, Madrid · Not applicable, Interventional, and Supportive care
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.
. 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
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 94 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Hospital San Carlos, Madrid is the lead sponsor of 72 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
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.
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:
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
Time frame: 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).
Time frame: 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.
Time frame: 2 minutes
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.
Time frame: 5-10 minutes
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.
Time frame: 2 minutes
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).
Time frame: 10 minutes
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.
Time frame: 8 minutes
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.
Time frame: 10 minutes
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).
Time frame: 10minutes
European Health Literacy Survey Questionnaire (HLS-EU Q16)
Measurement of literacy
Time frame: 5 minutes
Plan to share: No — The study results
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Hospital San Carlos, Madrid