Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
研究概览
简要总结
Participants with neurological disorders will be recruited to complete sessions of virtual reality (VR) immersion. VR has been shown to have therapeutic benefit in certain patient populations and requires further clinical study to determine the extent to which VR can be used to rehabilitate and reduce symptom burden. This study seeks to pilot newly developed VR methods and collect preliminary data in order to support research grants and inform larger clinical trials. Additionally, this proposed study will explore the tolerability and preliminary efficacy of Virtual Reality (VR), specifically to determine whether VR can acutely reduce the severity of symptom burden caused by neurological disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-79 years of age
- •Has been diagnosed by a clinician as having MS
- •Able to commit to the designated period of testing
- •Able to understand the informed consent process and provide consent to participate in the study
- •Capacity to complete study procedures as determined by screening personnel
- •A Brief Pain Inventory interference score of at least 3 or more.
- •SDMT Z-Score > -3.0
- •WRAT4 Standard Score > or = 85
排除标准
- •Visual, auditory, and motor deficits that would prevent full ability to understand study
- •Visual, auditory, and motor deficits that would prevent full ability to operate VR equipment
- •Uncontrolled epilepsy
- •Current diagnosis of vertigo
- •Uncontrolled mood disorders
- •History of Psychosis or Schizophrenia
- •Expanded Disability Status Scale (EDSS) Score greater than 6.5
- •Unable to tolerate or manipulate VR treatment procedures (as evidenced by VR capability assessment)
结局指标
主要结局
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
时间窗: Baseline (Week 1), Study End (Week 5)
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
次要结局
- Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score(Baseline (Week 1), Treatment End (Week 4))
- Change in PROMIS - Fatigue Score(Baseline (Week 1), Study End (Week 5))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score(Baseline (Week 1), Study End (Week 5))