Recruiting

Auditory Cues

Sponsor:

Clarkson University

Code:

NCT05048576

Conditions

Psychological

Auditory Perception

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Negative Reinforcement

Positive Reinforcement

Silence

Music

Study Details

Brief summary:

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.

Conditions

Psychological

Auditory Perception

Study ID

NCT05048576

Start date

Jun 1, 2021

Status verified date

Jan, 2022

Completion date

Dec 1, 2022

Anticipated

Primary completion date

Dec 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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 .

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: Music

Participants will be allowed to select a streaming music station of their choice.

active comparator: Silence

Participants will walk in silence while wearing noise cancelling headphones.

Interventions

Negative Reinforcement

Terms to be used in negative reinforcement:

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.

Positive Reinforcement

Terms to be used in positive reinforcement:

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.

Silence

No recordings will be played during this condition.

Music

Participant's can choose their own music to play during this condition.

Primary outcome measure

  • Profile of Moods Survey (POMS) Fatigue [ Time Frame: change in fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • Profile of Moods Survey (POMS) Vigor [ Time Frame: change in vigor from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • Profile of Moods Survey (POMS) Tension [ Time Frame: change in tension from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • Profile of Moods Survey (POMS) Depression [ Time Frame: change in depression from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • Profile of Moods Survey (POMS) Anger [ Time Frame: change in anger from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • Profile of Moods Survey (POMS) Confusion [ Time Frame: change in confusion from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • Profile of Moods Survey (POMS) Total Mood Disturbance [ Time Frame: change in total mood disturbance from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • State Mental Energy [ Time Frame: change in state mental energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • State Physical Energy [ Time Frame: change in state physical energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • State Mental Fatigue [ Time Frame: change in state mental fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • State Physical Fatigue [ Time Frame: change in state physical fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • Gait speed [ Time Frame: change in gait speed from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]
  • Gait variability [ Time Frame: change in variability from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking ]

Central Contacts and Locations

Central contacts

Ali Boolani, PhD

5043195828aboolani@clarkson.edu

Locations

Clarkson University

Recruiting

Potsdam, New York, United States, 13699

Contacts

Ali Boolani, PhD

aboolani@clarkson.edu

More Information

Sponsor

Clarkson University

Last update posted

Jan 19, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clarkson University on 2022-01-19.