The Effect of Auditory Cues on Mood and Gait

NCT ID: NCT05048576

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Psychological Auditory Perception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Positive Reinforcement

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Negative Reinforcement

Intervention Type BEHAVIORAL

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.

Music

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

Group Type EXPERIMENTAL

Music

Intervention Type BEHAVIORAL

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

Silence

Participants will walk in silence while wearing noise cancelling headphones.

Group Type ACTIVE_COMPARATOR

Silence

Intervention Type BEHAVIORAL

No recordings will be played during this condition.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Silence

No recordings will be played during this condition.

Intervention Type BEHAVIORAL

Music

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clarkson University

OTHER

Sponsor Role lead

Responsible Party

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Ali Boolani

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Boolani, PhD

Role: PRINCIPAL_INVESTIGATOR

Clarkson University

Locations

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Clarkson University

Potsdam, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ali Boolani, PhD

Role: CONTACT

5043195828

Facility Contacts

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Ali Boolani, PhD

Role: primary

Other Identifiers

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20-20.2

Identifier Type: -

Identifier Source: org_study_id

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