Clinical trial NCT05048576: The Effect of Auditory Cues on Mood and Gait
Official title: The Effect of Auditory Cues on Mood and Gait
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological
Auditory Perception
Lead sponsor: Clarkson University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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 .

Primary outcomes:
measure: Profile of Moods Survey (POMS) Fatigue
timeFrame: change in fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: Profile of Moods Survey (POMS) Vigor
timeFrame: change in vigor from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: Profile of Moods Survey (POMS) Tension
timeFrame: change in tension from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: Profile of Moods Survey (POMS) Depression
timeFrame: change in depression from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: Profile of Moods Survey (POMS) Anger
timeFrame: change in anger from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: Profile of Moods Survey (POMS) Confusion
timeFrame: change in confusion from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: Profile of Moods Survey (POMS) Total Mood Disturbance
timeFrame: change in total mood disturbance from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: State Mental Energy
timeFrame: change in state mental energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: State Physical Energy
timeFrame: change in state physical energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: State Mental Fatigue
timeFrame: change in state mental fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: State Physical Fatigue
timeFrame: change in state physical fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: Gait speed
timeFrame: change in gait speed from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
measure: Gait variability
timeFrame: change in variability from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Secondary outcomes:
Other outcomes:
Locations:
city: Potsdam
country: United States
facility: Clarkson University
state: New York
Study officials:
affiliation: Clarkson University
name: Ali Boolani, PhD
role: PRINCIPAL_INVESTIGATOR
References: