Promoting BEST (BEtter, Faster, Longer, STronger) Walking for People With Parkinson's
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps
研究概览
简要总结
This project aims to improve how people with Parkinson's Disease (PD) walk. The global aim is to identify obstacles and solutions for people with PD for adopting technology to track and improve their gait to make them better and safer walkers. To meet this aim members of Parkinson Quebec will be surveyed about their technology readiness, physical, cognitive, and psychological health, and rehabilitation access. The survey should not take more than 20 minutes to complete on the web. Subsequently, a random sample of 100 survey participants will be offered a wearable device, the Heel2ToeTM sensor, designed to improve gait quality. This device emits a beep when a proper step is taken. This external cue reinforces the adoption of an adequate gait. In addition to the device, participants will be offered 5 sessions of telemonitoring to help them use the device optimally. Monitoring of use and outcomes will be over 3 months and the sensor is theirs to keep.
详细描述
The global aim of this research program is to identify technical, attitudinal, and motivational obstacles and solutions for people with PD for adopting technology to improve gait and to quantify changes in gait biomechanics that will make participants better and safer walkers, ultimately improving physical function, physical activity, motivation, and quality of life.
Specific objective: Among members of the PQ who meet the criteria for technology readiness and have sufficient walking capacity to use the Heel2ToeTM sensor at home, the objectives are to estimate the extent to which they: (1) require support from the technology and rehabilitation team to optimize use; (2) use the sensor; (3) and change gait pattern, walking behaviours, motivation and functional and quality of life indicators over a period of 3 months.
Design: An individualized, blocked, stepped-wedge design will be used, a design favoured for implementation science questions 63,64 and applicable here as the team does not have the resources to implement the technology to all participants all at once. Parkinson Quebec has provided funds to provide sensors for 100 people. Variable size clusters of people will be formed and randomized to receive the Heel2Toe sensor, training, and remote supervised use, at intervals of 3 weeks. The cluster size will be randomly determined ranging from 4 to 10. As everyone selected for the implementation have already filled out the survey, there is a common data set at project entry. This assessment will be repeated prior to being entered into the Heel2Toe phase and then 3 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Everyone eventually gets the intervention, it is the order that is randomized. The outcome is gait quality measured directly from the sensor and is not affected by observers.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Technology readiness will be determined by the following criteria:
- •has a smartphone that is recent enough to support the technology or willing to acquire one
- •uses apps on the smartphone on most days of the week with or without the aid of another person
- •positively endorses the question "Are you interested in learning new things?"58 and "I walk outdoors on most days, weather permitting."
- •To screen participants for their capacity to use the Heel2Toe sensor, participants meeting the technology readiness criteria will be instructed to send a smartphone video of themselves doing a modified Timed-up-an-Go test65 in which the person, stands up from a chair, walks minimum of 10 meters (original TUG is 3 m.), turns, walks back to the chair, and sits down (long-TUG).
排除标准
- •unable to do the long TUG without assistance or need for a walking aid
- •unable to recover balance independently from a perturbation during execution of the long TUG
- •unable to reinitiate movement without assistance or without losing balance during a freezing event occurring during the long TUG. -
结局指标
主要结局
Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps
时间窗: Change from baseline to 3 months, 6 months, 1 year
degrees per second
Angular velocity of ankle during push-off averaged over a walk of a least 50 steps
时间窗: Change from baseline to 3 months, 6 months, 1 year
degrees per second
Angular velocity of ankle during foot swing averaged over a walk of a least 50 steps
时间窗: Change from baseline to 3 months, 6 months, 1 year
degrees per second
Co-efficient of variation of angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
时间窗: Change from baseline to 3 months, 6 months, 1 year
ratio of standard deviation to mean converted to percent.
次要结局
- Motivation(Change from baseline to 3 months, 6 months, 1 year)
- Walking behaviour(Change from baseline to 3 months, 6 months, 1 year)
- Health-related quality of life (HRQL)(Change from baseline to 3 months, 6 months, 1 year)
- Health-related quality of life (HRQL)better)(Change from baseline to 3 months, 6 months, 1 year)
- Apathy(Change from baseline to 3 months, 6 months, 1 year)
- Self-reported Cognitive Ability(Change from baseline to 3 months, 6 months, 1 year)
- Cognitive Performance Test(Change from baseline to 3 months, 6 months, 1 year)
研究者
Nancy Mayo
James McGill Professor
McGill University