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Clinical Trials/NCT05048576
NCT05048576UnknownNot Applicable

The Effect of Auditory Cues on Mood and Gait

Clarkson University2 sites in 1 country30 target enrollmentStarted: June 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
2
Primary Endpoint
Profile of Moods Survey (POMS) Fatigue

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Profile of Moods Survey (POMS) Fatigue

Time Frame: change in fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

0-20 scale with higher scores being worse outcome

Profile of Moods Survey (POMS) Vigor

Time Frame: change in vigor from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

0-20 scale with higher scores being better outcome

Profile of Moods Survey (POMS) Depression

Time Frame: change in depression from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

0 to 20 scale with higher scores being worse outcome

State Mental Energy

Time Frame: change in state mental energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

0 to 300 with higher scores being better outcomes

Profile of Moods Survey (POMS) Confusion

Time Frame: change in confusion from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

-4 to 16 scale with higher scores being worse outcome

Gait speed

Time Frame: change in gait speed from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

gait speed in meters/second

Profile of Moods Survey (POMS) Tension

Time Frame: change in tension from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

0 to 20 scale with higher scores being worse outcome

Profile of Moods Survey (POMS) Anger

Time Frame: change in anger from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

0 to 20 scale with higher scores being worse outcome

Profile of Moods Survey (POMS) Total Mood Disturbance

Time Frame: change in total mood disturbance from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

-24 to 96 with higher scores being worse outcomes

State Mental Fatigue

Time Frame: change in state mental fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

0 to 300 with higher scores being worse outcomes

Gait variability

Time Frame: change in variability from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

Variability in gait speed (reported as percent)

State Physical Energy

Time Frame: change in state physical energy from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

0 to 300 with higher scores being better outcomes

State Physical Fatigue

Time Frame: change in state physical fatigue from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking

0 to 300 with higher scores being worse outcomes

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ali Boolani

Associate Professor

Clarkson University

Study Sites (2)

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