A Pilot Study of In-lab Dynamic Standing in Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Gait Speed
研究概览
简要总结
This research is studying the use of a new type of standing desk in a small number of people to learn about the user experience for people with Parkinson's disease. 12 4-hour sessions will be performed to test the primary hypothesis that dynamic standing improves gait function compared to static standing and control sitting. This study has 2 phases. Phase 1 will be an open-label study and Phase 2 will be an in-lab randomized controlled trial pilot study. This is phase 1 of the study.
详细描述
For phase 1, participants will attend up to 12 4-hour sessions using the dynamic standing desk. In addition to these sessions, there will be a clinical assessment at baseline and an outcome session (endpoint assessments). In total, there will be up to 14 sessions per participant. All sessions need to be completed within 6 weeks. At the baseline session, clinical measurements will be collected. These measures will be repeated in the outcome session.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's Disease
排除标准
- •Inability to stand or walk without an assistive device
- •History of symptoms in stance that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain, or medication side effects
- •Any other history of medical or psychiatric comorbidity, precluding safe participation in the project.
- •History of symptomatic cardiovascular or pulmonary disease
- •History of active rheumatic arthritis
- •History of stroke or other neurologic conditions with significant residual sensorimotor deficits
- •History of disabling chronic pain syndrome requiring narcotic analgesics
- •Evidence of dementia (Mini Mental State Exam (or Montreal Cognitive Assessment test) <24 and significant impairment in activities of daily living)
- •Venous ulcerative stasis or severe varicosities.
- •Pregnancy as determined by urine pregnancy test prior to DXA procedure in women of childbearing potential.
研究组 & 干预措施
Dynamic Standing Desk in People with Parkinsons
Up to 12 4-hour sessions with the dynamic standing desk completed in the span of 6 weeks.
干预措施: Dynamic Standing Desk (Device)
结局指标
主要结局
Gait Speed
时间窗: Baseline and post-intervention (up to 6 weeks).
Gait speed will be measured during an 8.5-meter forward walking task measured in meters per second.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III
时间窗: Baseline and post-intervention (up to 6 weeks).
Clinical assessment that measures motor symptoms in Parkinson's Disease. Higher scores indicates more severe symptoms. Scores range from 0-132.
Montreal Cognitive Assessment
时间窗: Baseline and post-intervention (up to 6 weeks).
Clinical assessment that measures cognition. Higher scores indicate better cognition. Scores range from 0-30.
Timed Up and Go
时间窗: Baseline and post-intervention (up to 6 weeks).
Clinical assessment that measures the time it takes for a participant to stand from a chair, walk 3 meters, turn around, walk back to the chair and sit back down. Higher time indicates increased motor impairment.
5 Times Sit to Stand
时间窗: Baseline and post-intervention (up to 6 weeks).
Clinical assessment that measures the time it takes for a participant to sit and stand five times. Higher time indicates increased motor impairment.
次要结局
未报告次要终点
研究者
Chatkaew Pongmala
Research Investigator
University of Michigan