The Effect of Auditory Cues on Mood and Gait
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Profile of Moods Survey (POMS) Fatigue
研究概览
简要总结
The objective of this study is to identify the influence of positive and negative auditory cues, music and a placebo (silence) on mood and gait during 30 minutes of free walking. Participants will be required to walk for a total of 30 minutes with mood being measured every 5 minutes and gait measured throughout the 30 minute protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to stand without an assistive device
- •This study requires subjects to stand and to walk with the Delsys monitors, thus we are unable to use subjects who cannot stand without assistive devices.
- •Delsys monitors are a wearable device that allows for comprehensive analysis of gait and balance. The sensors will be attached to the subject and they will be instructed to perform the gait test by walking for 5 minute intervals over the duration of 63 minutes. The Delsys will generate a report automatically that will then be analyzed.
- •Able to walk in 5-minute intervals over the duration of 63 minutes without assistive devices.
- •The objective of this study is to measure gait. Assistive devices change gait and limit our ability to measure gait.
- •Subjects must be within the age of 18-45
排除标准
- •Impairment or inability to perform physical activity (e.g. walking) independently.
- •Inability to walk for 2 minutes without pain or discomfort.
- •Neurological conditions (i.e. stroke or Parkinson's disease)
- •○ Many neurological conditions can potentially alter gait. Therefore, we are eliminating individuals in this group.
- •Recent (within 6 months) orthopedic surgery that impacts walking ability and balance, e.g. total joint replacement
- •○ The objective of this study is to measure gait and people with lower extremity injuries may have excessive variation in gait. Hence we will be eliminating them from this study.
- •Wound or absent sensation on plantar surface (bottom) of the subject's feet.
- •○ Subjects with this issue will have alterations and variations in gait due to sensory deficits and/or pain. They will not eligible for this study.
- •Visual Impairment ○ Subjects must be able to read and visually recognize words. Therefore, subjects must have 20/40 (corrected) vision. Subjects who are blind cannot participate.
- •Day of testing eligibility
- •Subjects must not have consumed caffeine within the last 12 hours
- •Subjects must have slept >2 hours of their normal reported sleep time .
研究组 & 干预措施
Silence
Participants will walk in silence while wearing noise cancelling headphones.
干预措施: Silence (Behavioral)
Positive auditory cues
Participants will listen to the following auditory cues ~30 seconds apart Good job, you're doing awesome! Keep up the good work! You've got this! You're almost done, just a few more minutes! That's a great pace! You're going strong! Keep it up! Nice work. Great job! Good stuff. Keep it up. You're doing an amazing job.
干预措施: Positive Reinforcement (Behavioral)
Negative auditory cues
Participants will listen to the following auditory cues ~30 seconds apart You've got to walk faster than that. You're so slow! Why do you walk like that? Did you learn how to walk yesterday? You're doing terrible. Who walks like that? You have potential but you don't use it. You'll never amount to anything. You're not putting very much effort into this. This is the worst pace you've had yet.
干预措施: Negative Reinforcement (Behavioral)
Music
Participants will be allowed to select a streaming music station of their choice.
干预措施: Music (Behavioral)
结局指标
主要结局
Profile of Moods Survey (POMS) Fatigue
时间窗: change in fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
0-20 scale with higher scores being worse outcome
Profile of Moods Survey (POMS) Vigor
时间窗: change in vigor from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
0-20 scale with higher scores being better outcome
Profile of Moods Survey (POMS) Depression
时间窗: change in depression from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
0 to 20 scale with higher scores being worse outcome
State Mental Energy
时间窗: change in state mental energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
0 to 300 with higher scores being better outcomes
Profile of Moods Survey (POMS) Confusion
时间窗: change in confusion from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
-4 to 16 scale with higher scores being worse outcome
Gait speed
时间窗: change in gait speed from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
gait speed in meters/second
Profile of Moods Survey (POMS) Tension
时间窗: change in tension from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
0 to 20 scale with higher scores being worse outcome
Profile of Moods Survey (POMS) Anger
时间窗: change in anger from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
0 to 20 scale with higher scores being worse outcome
Profile of Moods Survey (POMS) Total Mood Disturbance
时间窗: change in total mood disturbance from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
-24 to 96 with higher scores being worse outcomes
State Mental Fatigue
时间窗: change in state mental fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
0 to 300 with higher scores being worse outcomes
Gait variability
时间窗: change in variability from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Variability in gait speed (reported as percent)
State Physical Energy
时间窗: change in state physical energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
0 to 300 with higher scores being better outcomes
State Physical Fatigue
时间窗: change in state physical fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
0 to 300 with higher scores being worse outcomes
次要结局
未报告次要终点
研究者
Ali Boolani
Associate Professor
Clarkson University