Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in variability in number of steps to complete a turn
研究概览
简要总结
The goal of this intervention is to explore the effectiveness of a Turning Intervention (TURN-IT) to improve quality of turning in participants with Parkinson's Disease (PD). An unique exercise program has been developed - TURN-IT - in which participants practice exercises that focus on physiological constraints that impair turning ability, such as axial rigidity, narrow base of support, bradykinesia, and inflexible set-shifting. The 60 participants with PD and a history of falls in the previous 12 months, will be randomized into a 6-week, 3x/week, one-on-one TURN-IT group or No-Intervention Control group. This pilot intervention study will determine the number of subjects needed for a future clinical trial and will determine the sensitivity to change with rehabilitation our daily-life turning quality measures (such as, mean and variability of number of steps to turn, turn amplitude, turn velocity). The investigators predict that the TURN-IT program will improve turning in daily life enough to justify a larger clinical trial.
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)
盲法说明
Investigators involved in measuring outcomes and analyzing the data, will remain blinded to the group that participants are assigned to.
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
- •Responsive to levodopa
- •Hoehn & Yahr stages II-IV
- •Age range 55-85 years old
- •self-report of one or more falls in past 12 months
- •willing and able to attend exercise intervention sessions at OHSU campus, and also refrain from changes in anti-parkinson medications and exercise levels.
排除标准
- •Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
- •no medical condition that precludes exercise
- •MoCA ≤ 21 or inability to follow directions
- •excessive use of alcohol or recreational drugs
- •recent change in medication
- •inability to stand and walk for 2 minutes without an assistive device
结局指标
主要结局
Change in variability in number of steps to complete a turn
时间窗: 6 weeks
Coefficient of variation in the number of steps in a turn, averaged from daily monitoring
次要结局
- Change in Falls Efficacy Scale International(6 weeks)
- Change in turn angle amplitude(6 weeks)
- Change in prospective fall rate(52 weeks)
- Change in patient global impression of change(6 weeks)
- Change in turn peak velocity(6 weeks)
- Change in turn duration(6 weeks)
- Change in turn trunk jerk(6 weeks)
- Change in lateral trunk range(6 weeks)
- Change in number of steps to complete a turn(6 weeks)
- Change in variability of double-support time(6 weeks)
研究者
Martina Mancini
Principal Investigator
Oregon Health and Science University