NCT05048576

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

August 13, 2021

Last Update Submit

January 4, 2022

Conditions

PsychologicalAuditory Perception

Outcome Measures

Primary Outcomes (13)

  • 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

    -24 to 96 with higher scores being worse outcomes

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

  • State Mental Energy

    0 to 300 with higher scores being better outcomes

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

  • State Physical Energy

    0 to 300 with higher scores being better outcomes

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

  • State Mental Fatigue

    0 to 300 with higher scores being worse outcomes

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

  • State Physical Fatigue

    0 to 300 with higher scores being worse outcomes

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

  • Gait speed

    gait speed in meters/second

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

  • Gait variability

    Variability in gait speed (reported as percent)

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

Study Arms (4)

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

Negative ReinforcementBEHAVIORAL

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.

Negative auditory cues
Positive ReinforcementBEHAVIORAL

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.

Positive auditory cues
SilenceBEHAVIORAL

No recordings will be played during this condition.

Silence
MusicBEHAVIORAL

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

Music

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clarkson University

Potsdam, New York, 13699, United States

RECRUITING

MeSH Terms

Interventions

SIR1 protein, S cerevisiaeMusic Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ali Boolani, PhD

    Clarkson University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Boolani, PhD

CONTACT

5043195828aboolani@clarkson.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 13, 2021

First Posted

September 17, 2021

Study Start

June 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)