The Effect of Auditory Cues on Mood and Gait | NCT05048576

NCT05048576

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Positive auditory cues	Experimental	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.	Behavioral: Positive Reinforcement
Negative auditory cues	Experimental	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.	Behavioral: Negative Reinforcement
Music	Experimental	Participants will be allowed to select a streaming music station of their choice.	Behavioral: Music
Silence	Active Comparator	Participants will walk in silence while wearing noise cancelling headphones.	Behavioral: Silence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Negative Reinforcement	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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
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
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
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
Profile of Moods Survey (POMS) Total Mood Disturbance

Eligibility Module

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

ID	Term
C084121	SIR1 protein, S cerevisiae
D009147	Music Therapy