The Effect of Auditory Cues on Mood and Gait

Clarkson University

Status

Unknown

Conditions

Psychological

Auditory Perception

Treatments

Behavioral: Positive Reinforcement

Behavioral: Negative Reinforcement

Behavioral: Silence

Behavioral: Music

Study type

Interventional

Funder types

Other

Identifiers

NCT05048576

20-20.2

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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 .

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 4 patient groups

Positive auditory cues

Experimental group

Description:

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.

Treatment:

Behavioral: Positive Reinforcement

Negative auditory cues

Experimental group

Description:

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.

Treatment:

Behavioral: Negative Reinforcement

Music

Experimental group

Description:

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

Treatment:

Behavioral: Music

Silence

Active Comparator group

Description:

Participants will walk in silence while wearing noise cancelling headphones.