Evaluation of the Effectiveness of the "VRTierOne" Virtual Therapeutic Game as a Method Supporting the Post-stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- The Geriatric Depression Scale (GDS)
研究概览
简要总结
Thanks to using VR googles and the phenomenon of total immersion "VR Tier One" allows to completely separate the patient from the hospital environment, provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or, in another part of the game, it can motivate and cognitively activate the patient. The additional aim of the game is to help the patients regain their emotional balance, let them recognize their resources in order to bring them to power in the rehabilitation process and trigger the natural recovery mechanisms.
详细描述
The goals of the project:
- The evaluation of the influence of virtual therapeutic game on the mood and wellbeing of the patients undergoing post-stroke rehabilitation.
- The evaluation of the influence of virtual therapeutic game on the acceptance of the illness and self-efficacy assessment of the patients undergoing post-stroke rehabilitation.
- The evaluation of the influence of virtual therapeutic game on the effectiveness of post-stroke rehabilitation process in relation to locomotive function as well as basic and instrumental activities of daily living.
- The analysis of possible side effects appearing while using virtual reality therapy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke
- •depression symptoms scored 10 and more in Geriatric Depression Scale (GDS-30)
排除标准
- •cognitive functions (MMSE<24)
- •epilepsy,
- •aphasia and a serious loss of sight or hearing that makes it impossible to assess cognitive functions based on MMSE,
- •presence at the time of the examination or in the medical data: mental retardation, disturbances of consciousness or other serious mental disorders,
- •patient's refusal at any stage of the research project
研究组 & 干预措施
VR Tier One
Patients will receive:
- 10 sessions of 20 minutes of VR Tire One therapeutic game,
- 60 minutes of individual physiotherapy based on the Bobath and PNF concept with elements of manual therapy,
- 30 minutes individual aerobic training,
- 30 minutes balance exercises.
干预措施: VR Tier One (Device)
Control
Patients will receive:
- 10 sessions of 20 minutes of Schultz Autogenic Training,
- 60 minutes of individual physiotherapy based on the Bobath and PNF concept with elements of manual therapy,
- 30 minutes individual aerobic training,
- 30 minutes balance exercises.
干预措施: Control (Other)
结局指标
主要结局
The Geriatric Depression Scale (GDS)
时间窗: 20 minutes
The Geriatric Depression Scale is a self-report 30-items measure of well-being and mood in older adults. The patient responds in a "Yes/No" format. Scoring ranges from 0 to 30, where 11 and more means mood disorders. The higher score means the greater depression. GDS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
Generalized Self-Efficacy Scale (GSES)
时间窗: 20 minutes
Generalized Self - Efficacy Scale consists of 10 statements. In each question, the patient can get 4 points. The scale measures the strength of the general belief of the individual about the effectiveness of coping with difficult situations and unexpected events as well as determination in pursuing the goal. Scoring ranges from 10 to 40 points. The more points the patient gets, the better he assesses his effectiveness in dealing with problems. The GSES will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
Hospital Anxiety and Depression Scale (HADS)
时间窗: 15 minutes
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
Acceptance of Illnes Scale (AIS)
时间窗: 10 minutes
Acceptance of Illness Scale contains eight statements describing the consequences of poor health. Scoring is in the range of 8 to 40 points. A small number of points means no acceptance of the disease and a strong sense of mental discomfort, while a high score means adaptation to the situation and lack of negative emotions associated with the disease. The AIS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
The Visual Analogue Scale of Pain (VAS)
时间窗: 3 minute
The Visual Analogue Scale of Pain is a psychometric measurement for intensity of pain, assesses the pain sensation on a scale of 0 to 10, where 0 means no pain and 10 means unbearable pain. The VAS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
次要结局
- The Barthel Index (BI)(30 minutes)
- Lawton's Scale(30 minutes)
- Rivermead Motor Assesment (RMA)(30 minutes)
研究者
Joanna Szczepańska-Gieracha
Professor
Wroclaw University of Health and Sport Sciences