Immersive Virtual Reality in Post Stroke

Yolanda Marcen Roman

Status: Active, not recruiting

Conditions: Balance; Stroke; Virtual Reality; Physical Therapy

Treatments: Other: Control group; Other: Virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT04379687

VR stroke

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Virtual reality

Experimental group

Description:

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

Treatment:

Other: Virtual reality

Control group

Active Comparator group

Description:

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

Treatment:

Other: Control group