Evaluating and Improving Robot Assisted Gait Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Heart Rate Response to Exercise
研究概览
简要总结
Early use of robotic gait trainers have shown many benefits, however why these benefits occur and how to maximize them is unknown. There are a few options for how a robotic gait trainer can be used, however, there is not much understanding of how these options impact rehabilitation and compensate for impairments. The investigators aim to evaluate the impacts of as single session of Trexo robotic gait training and the impact of different modes of the Trexo robotic gait trainer. The investigators will evaluate how the different settings impact things like physical activity, walking, brain activity, spasticity, and fatigue. Investigators will arrange for a familiarity and fitting session to start, so that study team members can fit the participant to the Trexo and so that participants can become familiar with the feeling of using the Trexo robotic gait trainer. After the initial fitting sessions, follow up sessions will be completed to evaluate different settings on the Trexo, for example in "endurance" mode (where the robot completes the movements for the participant) and in "strength" mode (where the robot requires some assistance from the participant). Investigators may also test different fitting settings, for example with and without the supportive seat in the Trexo. Only three visits are required (one fitting/familiarity session and two testing sessions), however participants and/or their families may choose to complete more testing sessions if they want to assess other aspects of the training. For example, if the first two testing sessions assessed physical activity, participants and their families may choose to return for further sessions to assess brain activity. The aim of the study is to determine how robot assisted gait training impacts rehabilitation and compensates for impairments, as well as to provide suggestions on how the robotic gait trainer might be improved or modified. This study is exploratory to find out more about how these robotic gait trainers, specifically the Trexo, impacts various aspects of rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will not know which mode they are completing on which day. Caregivers may be told if they ask, and investigators and outcome investigators will know the randomization.
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to fit into the Trexo robotic gait trainer (<150 lbs., <5'7").
- •Has impaired ability to walk due to a neurological or muscular disorder.
排除标准
- •>150 lbs.
- •>5'6" tall
- •Medical contraindication to weight bearing (ie. recent orthopedic surgery)
研究组 & 干预措施
Passive "Endurance"
Participants will complete a training session using the Trexo robotic gait trainer in the "endurance" mode with a fixed gait pattern regardless of the participant's activity.
干预措施: Robot Assisted Gait Training (Device)
Voluntary activity "Strength"
Participants will complete a training session using the Trexo robotic gait trainer in the "strength" mode where the gait pattern is impacted by the participant's activity
干预措施: Robot Assisted Gait Training (Device)
结局指标
主要结局
Change in Heart Rate Response to Exercise
时间窗: Through study completion, an average of 4 weeks.
We will use the collected heart rate as well as an estimated maximum heart rate (208-0.7\*age) to determine the heart rate reserve (estimated maximum heart rate minus measured resting heart rate). Once the heart rate reserve has been calculated, the measured heart rate throughout the session will be used to determine how much time the participant spent above 40% of their heart rate reserve.
次要结局
- Leg Muscle Spasticity(Through study completion, an average of 4 weeks.)
- Physical Activity Level(Through study completion, an average of 4 weeks.)
- Duration of Exercise Session(Through study completion, an average of 4 weeks.)
- Muscle Activation(Through study completion, an average of 4 weeks.)
- Total Number of Steps Taken(Through study completion, an average of 4 weeks.)
- Brain Region Activation(Through study completion, an average of 4 weeks.)
- Characteristics of Gait / Walking Pattern(Through study completion, an average of 4 weeks.)
- Average Number of Steps per Minute(Through study completion, an average of 4 weeks.)
- Participant or Proxy Report of Rating of Perceived Exertion (RPE)(Through study completion, an average of 4 weeks.)
研究者
Elizabeth Condliffe, PhD MD
Assistant Clinical Professor
University of Calgary