Clinical Validation of Self-Pacing Algorithms on Step Length Symmetry in Hemiplegic Populations
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference in step length symmetry with self-pacing versus fixed-pacing treadmill walking
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of self-pacing algorithms in promoting step-length equalization in people with weakness on one side of the body. The main question it aims to answer is:
• How does walking on a treadmill that uses self-pacing algorithms to adjust speed affect stride length in comparison to walking on a treadmill without self-pacing capability? Researchers will compare study participants to themselves when walking on a self-pacing treadmill compared to walking on a fixed-pacing treadmill to see if a difference exists in the equalization of left- and right-sided stride length.
Participants will walk for two minutes at a self-selected pace to warm up and establish a baseline walking speed. They will then walk for 1 - 3 minutes either on a self-pacing treadmill or a fixed-pacing treadmill. A 3-minute seated rest break will follow. Then participants will walk for another 1 - 3 minutes using the treadmill not used in the first walking trial.
详细描述
The chosen treadmill has self-pacing algorithms installed that adjust speed as a person walks. This allows a person to increase or decrease speed as desired throughout a walking session. Researchers have not yet determined the effect of using a self-pacing treadmill on left-right gait equalization among people with acquired hemiparesis secondary to stroke or traumatic brain injury. The researchers will compare measurement data captured by the system software when participants walk on the treadmill with the self-pacing feature turned on versus off. Each walking trial will last 1 - 3 minutes and will occur in a random order during a single research session. The randomization is to ensure that fatigue is not a factor when interpreting results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current client of Quality Living, Inc., in Omaha, NE
- •19 to 75 years of age
- •Speak and understand English
- •Can ambulate overground for at least 10 minutes with or without use of aids
- •Medically cleared for treadmill exercise
- •Hemiparesis secondary to stroke or traumatic brain injury
排除标准
- •Has not retained power of attorney for healthcare
研究组 & 干预措施
Self-pacing treadmill walking first, then fixed-pacing treadmill walking
干预措施: Walking on self-pacing treadmill (Behavioral)
Self-pacing treadmill walking first, then fixed-pacing treadmill walking
干预措施: Walking on fixed-pacing treadmill (Behavioral)
Fixed-pacing treadmill walking first, then self-pacing treadmill walking
干预措施: Walking on self-pacing treadmill (Behavioral)
Fixed-pacing treadmill walking first, then self-pacing treadmill walking
干预措施: Walking on fixed-pacing treadmill (Behavioral)
结局指标
主要结局
Difference in step length symmetry with self-pacing versus fixed-pacing treadmill walking
时间窗: 1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill during a single experimental session.
Non-hemiparetic side step length minus hemiparetic side step length when walking on self-pacing versus fixed pacing treadmill.
Difference in step-length on hemiparetic and non-hemiparetic sides
时间窗: 1-3 minutes of walking on self-pacing treadmill and 1-3 minutes of walking on fixed-pacing treadmill.
Length of forward movement of each foot during each walking step as measured in centimeters.
次要结局
未报告次要终点
研究者
Karen Hux, Ph.D.
Director of Research
Quality Living, Inc.