Protective Step Training in People With Parkinson's Disease and Postural Disturbances
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Stepping performance, measured as Margin of Stability (MOS)
研究概览
简要总结
The primary purpose of this project is to determine the preliminary effectiveness of protective step training to improve balance and reduce falls in people with Parkinson's disease (PD) and postural disturbances. A secondary purpose is to understand which baseline patient characteristics predict responsiveness to treatment. By informing 1) the effectiveness of a promising rehabilitative intervention, and 2) the selection of the participants that will be most responsive to treatment, these data may enhance clinicians' ability to treat balance disturbances in people with PD. Importantly, protective step training, described in this proposal, can be quickly deployed in the clinic at minimal cost. Therefore, if shown to be effective via this and subsequent trials, this approach can be easily integrated into care, immediately impacting a large number of people with PD.
详细描述
This project contains 3 aims: Aims 1 and 2 address the primary goal of this project: Determining the effectiveness of protective step training. Aim 1 will test whether perturbation training can improve protective stepping in people with PD with postural dysfunction. Aim 2 will test whether improvements are retained over 2 months and generalize to untrained perturbation tasks (which may be important for real world situations). Importantly, investigators will also gather exploratory data regarding the effect of perturbation training on falls. Aim 3 addresses the secondary goal of this project: Determining for whom protective step training is most beneficial. Aim 3 will relate behavioral factors and neuroimaging outcomes to the magnitude of improvement in protective stepping. All aims will be tested in people with PD who have postural disturbances.
To complete these aims, participants will undergo 12 visits to the laboratory over the course of about 5 months. These will include 6 "training visits" over the course of 2 weeks, surrounded by 6 "assessment" visits before and after the training. During assessment visits, investigators will assess the ability to step quickly in response to a loss of balance (e.g. a slip), as well as thinking assessments and, if eligible, investigators will complete an MRI. During training visits, investigators will train the ability to step quickly in response to a slip.
In this study, participants will serve as their own controls. As such, there is no randomization to multiple groups.
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
盲法说明
The single-group assessment prohibits participant/outcomes masking.
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neurologist diagnosed PD
- •Postural Instability / Gait Dysfunction (PIGD)
- •Ability to stand unaided for 5 minutes
排除标准
- •non-PD related neurological pathology
- •orthopedic impairments affecting balance
结局指标
主要结局
Stepping performance, measured as Margin of Stability (MOS)
时间窗: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
MOS: Distance between the extrapolated center of mass and base of support at first foot contact after the slip
次要结局
- Stepping performance, measured as First Step Latency(Change across baseline period (2 weeks), compared to change across intervention period (2 weeks))
- Cognition, measured as the total score on the "SCales for Outcomes in PArkinson's disease-COGnition" (SCOPA-COG)(Baseline)
- Structural brain connectivity between the cortex (supplementary motor area), and basal ganglia (striatum)(Baseline)
- Stepping performance, measured as First Step Length(Change across baseline period (2 weeks), compared to change across intervention period (2 weeks))