The Effect of Auditory Cues on Mood and Gait

Psychological Clinical Trial

Official title:

The Effect of Auditory Cues on Mood and Gait

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048576
• Other study ID #: 20-20.2
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2022
• Source: Clarkson University
• Contact: Ali Boolani, PhD
• Phone: 5043195828
• Email: aboolani[@]clarkson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Auditory Perception
• Psychological

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Clarkson University	Potsdam	New York

Sponsors (1)

Lead Sponsor	Collaborator
Clarkson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profile of Moods Survey (POMS) Fatigue	0-20 scale with higher scores being worse outcome	change in fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	Profile of Moods Survey (POMS) Vigor	0-20 scale with higher scores being better outcome	change in vigor from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	Profile of Moods Survey (POMS) Tension	0 to 20 scale with higher scores being worse outcome	change in tension from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	Profile of Moods Survey (POMS) Depression	0 to 20 scale with higher scores being worse outcome	change in depression from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	Profile of Moods Survey (POMS) Anger	0 to 20 scale with higher scores being worse outcome	change in anger from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	Profile of Moods Survey (POMS) Confusion	-4 to 16 scale with higher scores being worse outcome	change in confusion from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	Profile of Moods Survey (POMS) Total Mood Disturbance	-24 to 96 with higher scores being worse outcomes	change in total mood disturbance from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	State Mental Energy	0 to 300 with higher scores being better outcomes	change in state mental energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	State Physical Energy	0 to 300 with higher scores being better outcomes	change in state physical energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	State Mental Fatigue	0 to 300 with higher scores being worse outcomes	change in state mental fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	State Physical Fatigue	0 to 300 with higher scores being worse outcomes	change in state physical fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	Gait speed	gait speed in meters/second	change in gait speed from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Primary	Gait variability	Variability in gait speed (reported as percent)	change in variability from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking