Medical Recovery and Social Reintegration for Post-stroke Patients With Sequelae Using Virtual Reality
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The number of patients for whom tailored Virtual Reality therapy is more efficient than standard tailored physiotherapy in the recovery of post-stroke sequelae.
研究概览
简要总结
Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients with post-stroke sequelae, using specifical assessment tools, standard physiotherapy and occupational therapy programs.
详细描述
- Initial and final clinical and functional evaluation of patients with post-stroke sequelae, storage and use of data obtained.
- Collection and access of demographic and clinical data of patients included in the study (respecting the principle of confidentiality and non-publication of personal data) only by staff involved in the research project and working in the Clinical Hospital of Psychiatry and Neurology in Brasov.
- Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients who meet the criteria for inclusion in the study (scapulohumeral flexion and abduction of at least 20 degrees, elbow flexion of at least 20 degrees, hip and knee flexion of at least 20 degrees, without severe aphasia or severe behavioural/cognitive disorders).
- Use of data obtained from the application of Virtual Reality therapy at home, through Telerehabilitation, if patients procure alone or through sponsorship/donation the equipment necessary to continue the Virtual Reality therapy program at home, taking into account that the technology purchased through the project allows this.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke survivors after the acute phase, at least 6 weeks post-stroke;
- •stroke survivors within no more than 4 years after stroke,
- •at least 30-degree flexion and scapulohumeral abduction against gravity.
- •elbow flexion of at least 30 degrees
- •hip flexion of at least 30 degrees
- •knee flexion of at least 30 degrees
排除标准
- •no severe cognitive impairments,
- •no global or transcortical sensory aphasia,
- •no other dysfunctions in the upper extremity such as surgery, fractures, shoulder arthritis or severe pain,
- •no other dysfunctions in the lower extremity such as surgery, fractures, arthritis or severe pain,
- •without anaemia
- •without atrial fibrillation
- •without NYHA class IV heart failure
研究组 & 干预措施
Control Group
Standard physiotherapy and OT
干预措施: Standard Physiotherapy (Other)
Experimental
Virtual Reality Therapy and OT
干预措施: Non-immersive virtual reality therapy (Other)
结局指标
主要结局
The number of patients for whom tailored Virtual Reality therapy is more efficient than standard tailored physiotherapy in the recovery of post-stroke sequelae.
时间窗: One year since the beginning of the research
Determining the factors and parameters that influence or enhance post-stroke recovery capacity using new recovery methods, such as non-immersive virtual reality. The assessment tools are: the Fugl-Meyer assessment for the upper extremity (FMUE), Fugl-Meyer assessment for the lower extremity (FMLE), the Modified Rankin Scale (MRS), the Functional Independence Measure (FIM), the Active Range of Motion (AROM), the Manual Muscle Testing (MMT), the Modified Ashworth Scale (MAS), the Functional Reach Test (FRT), and Timed Up and Go Test (TUG). The patients are assessed by recovery medical doctors (physiatrists) regarding FIM, MAS and MRS. While FMUE, FMLE, AROM, MMT, FRT, TUG are assessed by trained physiotherapists, with at least 5 years of experience in stroke sequelae physiotherapy and evaluation.
次要结局
- The number of patients for whom heart disease and other elderly condition, age or gender are influencing the capacity to the recovery of post-stroke patients.(One year since the beginning of the research)