Immersive Virtual Reality in Post Stroke
- Conditions
- BalanceVirtual RealityPhysical TherapyStroke
- Interventions
- Other: Control groupOther: Virtual reality
- Registration Number
- NCT04379687
- Lead Sponsor
- Yolanda Marcen Roman
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control group 1. st part: Conventional physiotherapy treatment program aimed at achieving functional improvement and increased postural control.15 minutes 2. nd part: Training program for static and dynamic balance in sitting and standing, according to Bayouk. 15 minutes Virtual reality Virtual reality 1. st part: Conventional physiotherapy treatment program aimed at achieving functional improvement and increased postural control. 15 minutes 2. nd part: Experimental training program for static and dynamic balance in sitting and standing by immersive Virtual Reality. 15 minutes
- Primary Outcome Measures
Name Time Method 10 meter walk test. 15 minutes Dynamic balance and gait
Berg Balance Scale 15 minutes 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).
Timed Get uo and go test 10 minutes Dynamic balance and gait
Postural Assessment Scale for Stroke Patients (PASS). 45 minutes 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 36Balance Evaluation Systems Test (BESTtest) 45 minutes Static balance and functional mobility
- Secondary Outcome Measures
Name Time Method Stroke-specific quality of life scale (ECVI-38) 15 minutes 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)
The Barthel Index 10 minutes 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
Ad hoc questionnaire 10 minutes Adverse effects
Trial Locations
- Locations (1)
Hospital universitario Miguel servet
🇪🇸Zaragoza, Spain