Upper-limb Functional Recovery With Virtual Reality System (BTs-Nirvana) Associated With Conventional Therapy in Hospitalized Subacute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Upper limb motor function as assessed by Fugl-Meyer Upper-Limb scale (FM-UL)
研究概览
简要总结
The goal of this pilot study is to evaluate if a semi-inmersive virtual reality device works in the recovery of the function of the upper limb affected in hospitalized patients who have suffered a stroke.
Reseachers will compare the virtual reality device plus the usual treatment to usual treatment to see if virtual reality device works to recovery upper limb function.
Participants will be able to receive conventional treatment or virtual therapy plus conventional treatment 5 days a week for 4 weeks.
When they are discharged, they will come to the hospital 2 times to be reviewed, 3 months and 1 year after receiving treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke confirmed by neuroimaging.
- •No previous stroke.
- •Subacute phase (between 1 and 6 months after the stroke).
- •Ability to sit with or without support.
- •Maximum 4 on the Muscle Strength Scale (MRC) for shoulder flexion and flexion-extension of the elbow of the upper limb on the affected side.
- •Ability to understand and accept study procedures and to sign an informed consent having been previously informed.
排除标准
- •Previous history of brain injury, stroke and neurological or neuropsychiatric diseases.
- •Cognitive alterations, dementia, aphasia or other alteration that causes inability to understand the meaning of the study.
- •Clinical inestability
- •Loss of visual capacity that difficults recognizing figures on the screen.
- •Orthopedic conditions involving upper limbs.
- •Refusal to participate in the study.
结局指标
主要结局
Upper limb motor function as assessed by Fugl-Meyer Upper-Limb scale (FM-UL)
时间窗: at baseline, 4 weeks, 3 months and a year after treatment
The maximum value of the motor function in the FM-UL scale is 66 points. A higher score corresponds to a better state of operation of the patient.
次要结局
- Daily-life activities as assessed as Barthel Index (BI)(at baseline, 4 weeks, 3 months and a year after treatment)
- Trunk control as assessed as Control Trunk Test (TCT)(at baseline, 4 weeks, 3 months and a year after treatment)
- Daily-life activities as assessed as Self-Assessment of Role Performance and Activities of Daily Living (SARA-TM)(at baseline, 4 weeks, 3 months and a year after treatment)
研究者
Lorena Aguilar Cano
Principal Investigator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud