Pilot Study of Relaxation Guided Imagery for the Treatment of Motor Fluctuations in Parkinson's Disease's
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline of Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
Parkinson's disease patients may have pronounced ON-OFF motor fluctuations. These motor fluctuations are currently treated with medication and surgery, which are limited by their efficacy and side effects. Our study aims to determine whether relaxation guided imagery can alleviate the OFF state of PD patients and therefore can be used as an adjunct to conventional medication.
详细描述
Parkinson's disease patients with pronounced ON-OFF motor fluctuations without dementia will participate in this study aimed to examine a possible beneficial effect of relaxation guided imagery on motor fluctuations. The study will include a baseline period two sessions of relaxation and a follow-up period. The relaxation sessions will be conducted individually. In one session patients will hear relaxing music and in the second they will undergo relaxation guided imagery. After each relaxation session patients will receive a CD with either relaxing music or RGI to listen to at home. They will be asked to fill out a diary at baseline and after each session. Before and after each relaxation session patients will be examined according to the Unified Parkinson's Disease Rating Scale and the examination will be videotaped. All patients will continue to receive the usual care from their medical providers. The main measure is change in UPDRS and secondary measure is change in daily OFF time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic Parkinson's disease suffering from motor fluctuations
排除标准
- •hearing impairment
结局指标
主要结局
Change from baseline of Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: 30 minutes
* Unified Parkinson's Disease Rating Scale (UPDRS) score after RGI as compared to baseline * OFF time after RGI as compared to baseline
次要结局
- Change from baseline to week 2 in Clinical Global Impression Scale (CGI)(2 weeks)
- Change from baseline to week 2 in PDQ39(2 weeks)
- Change from baseline to minutes 30 of Unified Parkinson's Disease Rating Scale (UPDRS) after relaxing music(30 minutes)
- Change from baseline to month 3 in Clinical Global Impression Scale (CGI)(3 months)
- Change from baseline to week 2 in the number of OFF hours(2 weeks)
- Change from baseline to week 1 in the number of OFF hours(1 week)
- Change from baseline to month 3 in PDQ39(3 months)
研究者
Ilana Schlesinger
Director, Movement Disorders Institute
Rambam Health Care Campus