Immersive Virtual Reality in Post Stroke Physiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- 10 meter walk test.
研究概览
简要总结
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.
详细描述
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 .
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
10 meter walk test.
时间窗: 15 minutes
Dynamic balance and gait
Berg Balance Scale
时间窗: 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
时间窗: 10 minutes
Dynamic balance and gait
Postural Assessment Scale for Stroke Patients (PASS).
时间窗: 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 36
Balance Evaluation Systems Test (BESTtest)
时间窗: 45 minutes
Static balance and functional mobility
次要结局
- Stroke-specific quality of life scale (ECVI-38)(15 minutes)
- The Barthel Index(10 minutes)
- Ad hoc questionnaire(10 minutes)
研究者
Yolanda Marcen Roman
Principal investigador
Instituto de Investigación Sanitaria Aragón