Immersive Virtual Reality in Post Stroke

Study Overview
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Brief Summary
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Physiotherapy intervention programs in the post-stroke patient should develop strategies to assess functional deficit, prevent poorly adaptive plasticity and maximize functional gain. For relearning and functional training, the required activities require motor control and must comply with the following principles: movements close to normal, muscular activation, movement conduction, focused attention, repetition of desired movements, specificity of training, intensity and transfer. These principles underlie the most widely used conventional physiotherapy intervention programs in the hospital setting. Advances in technology have made it possible to start using immersive VR in the therapeutic approach to various pathologies that affect motor function.

Detailed Description
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Physiotherapy intervention programs in the post-stroke patient should develop strategies to assess functional deficit, prevent poorly adaptive plasticity and maximize functional gain. For relearning and functional training, the required activities require motor control and must comply with the following principles: movements close to normal, muscular activation, movement conduction, focused attention, repetition of desired movements, specificity of training, intensity and transfer. These principles underlie the physiotherapy intervention programs specifically most used in the hospital setting. Main aims 1-To determine if the designed immersive VR training program is better in the short term (15 sessions) and in the medium term (30 sessions) than the conventional physiotherapy training with respect to the change of the parameters related to the static balance in sitting and standing and dynamic balance in post-stroke patients. Secondary aims 2. To determine the efficacy in the short term (15 sessions) and in the medium term (30 sessions) of immersive VR systems compared to conventional physiotherapy procedures regarding the quality of life associated with stroke, the degree of independence and autonomy . 3. To determine the safety of the application of training programs in immersive VR settings in post-stroke subjects with respect to the number of adverse effects produced. 4. Determine prognostic factors associated with insufficient improvement (less than moderate change) after stroke treatment with the designed immersive VR program and with conventional physiotherapy treatment.

Official Title
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Immersive Virtual Reality in Post Stroke Physiotherapy

Conditions
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Balance, Stroke, Physical Therapy, Virtual Reality

Intervention / Treatment
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* Other: Virtual reality
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults> 18 years and <80 years. Diagnosis of hemiparesis or post-stroke hemiplegia. Minimum score of 2 points on item 3.2 of the Berg Scale, which establishes that the patient can remain in a sitting position for 30s without help. Exclusion Criteria: Aphasia, scores over 45 on the Mississippi Aphasia Screening Test. Cerebellar pathology. Hemineglect or previous neurological disorder. Visual disturbances that prevent the use of VR glasses. Moderate cognitive decline, scores less than 43 on the Mini-mental State examination. Previous musculoskeletal disorders that make it difficult or impossible to balance sitting and standing or walking.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>st part: Conventional physiotherapy treatment program aimed at achieving functional improvement and increased postural control. 15 minutes nd part: Experimental training program for static and dynamic balance in sitting and standing by immersive Virtual Reality. 15 minutes | Other: Virtual reality<br>* Use of virtual reality glasses for balance work<br>|
| Active Comparator: Control group<br>st part: Conventional physiotherapy treatment program aimed at achieving functional improvement and increased postural control.15 minutes nd part: Training program for static and dynamic balance in sitting and standing, according to Bayouk. 15 minutes | Other: Control group<br>* Balance treatment with according to Bayouk physiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural Assessment Scale for Stroke Patients (PASS). | Static balance and functional mobility, This consists of 12 items and is subdivided into two parts: mobility (7 items) and balance (5 items), each with a score ranging from 0 (minimum) to 3 (maximum); the total scale score is 36 points. The PASS is made up of 12 items of increasing difficulty, of a 4-point scale in which items are scored from 0 to 3. The total score varies from 0 to 36 | 45 minutes | 
| 10 meter walk test. | Dynamic balance and gait | 15 minutes | 
| Berg Balance Scale | Static balance and functional mobility The Berg scale comprises 14 items (score comprised 0-4). Total scores can range from 0 (severely impaired balance) to 56 (excellent balance). | 15 minutes | 
| Balance Evaluation Systems Test (BESTtest) | Static balance and functional mobility | 45 minutes | 
| Timed Get uo and go test | Dynamic balance and gait | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke-specific quality of life scale (ECVI-38) | Quality of life associated with stroke It has comprises 38 items, (score comprised 1-5). Total scores can range from 38 (excellent) to 190 point (very poor quality of life) | 15 minutes | 
| The Barthel Index | Degree of autonomy The sum of the scores obtained will determine the degree of dependency, so if the person is less than 20, they are considered totally dependent, if they are between 40 and 55, they are moderately dependent, if they are over 60, they are considered to be dependent mild and if it is 100 it will be totally independent (95 in case you need the use of a wheelchair | 10 minutes | 
| Ad hoc questionnaire | Adverse effects | 10 minutes |