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The Effect of Auditory Cues on Mood and Gait

The Effect of Auditory Cues on Mood and Gait

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05048576
Enrollment
30
Registered
2021-09-17
Start date
2021-06-01
Completion date
2022-12-01
Last updated
2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological, Auditory Perception

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.

Interventions

BEHAVIORALNegative 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.

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.

BEHAVIORALSilence

No recordings will be played during this condition.

BEHAVIORALMusic

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

Sponsors

Clarkson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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 .

Design outcomes

Primary

MeasureTime frameDescription
Profile of Moods Survey (POMS) Fatiguechange in fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking0-20 scale with higher scores being worse outcome
Profile of Moods Survey (POMS) Vigorchange in vigor from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking0-20 scale with higher scores being better outcome
Profile of Moods Survey (POMS) Tensionchange in tension from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking0 to 20 scale with higher scores being worse outcome
Profile of Moods Survey (POMS) Depressionchange in depression from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking0 to 20 scale with higher scores being worse outcome
Profile of Moods Survey (POMS) Angerchange in anger from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking0 to 20 scale with higher scores being worse outcome
Profile of Moods Survey (POMS) Confusionchange 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
Profile of Moods Survey (POMS) Total Mood Disturbancechange 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 Energychange in state mental energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking0 to 300 with higher scores being better outcomes
State Physical Energychange in state physical energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking0 to 300 with higher scores being better outcomes
State Mental Fatiguechange in state mental fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking0 to 300 with higher scores being worse outcomes
State Physical Fatiguechange in state physical fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking0 to 300 with higher scores being worse outcomes
Gait speedchange in gait speed from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walkinggait speed in meters/second
Gait variabilitychange in variability from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walkingVariability in gait speed (reported as percent)

Countries

United States

Contacts

Primary ContactAli Boolani, PhD
aboolani@clarkson.edu5043195828

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026