PsychologicalNCT05048576
The Effect of Auditory Cues on Mood and Gait
A study testing Negative Reinforcement, Positive Reinforcement and Silence in people with Psychological and Auditory Perception, run by Clarkson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological, Auditory Perception
- What is being tested?
- Negative Reinforcement, Positive Reinforcement and Silence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 .
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Clarkson University
Potsdam, New York, 13699
Ali Boolani, PhD, aboolani@clarkson.edu
About this study
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.
- Conditions
- Psychological, Auditory Perception
- Being tested
- Negative Reinforcement, Positive Reinforcement, Silence, Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative ReinforcementBehavioural
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.
Positive ReinforcementBehavioural
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.
SilenceBehavioural
No recordings will be played during this condition.
MusicBehavioural
Participant's can choose their own music to play during this condition.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Negative Reinforcement |
| Music | Experimental | Participants will be allowed to select a streaming music station of their choice. Receives: Behavioral: Music |
| Silence | Active comparator | Participants will walk in silence while wearing noise cancelling headphones. Receives: Behavioral: Silence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Moods Survey (POMS) Fatigue
0-20 scale with higher scores being worse outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: change in variability from baseline to 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes during walking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Jun 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarkson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Boolani, Clarkson University
- Investigators
- Ali Boolani, PhD, Principal investigator, Clarkson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048576
- Sponsor's protocol ID
- 20-20.2
- Status last verified
- Jan 2022
- First submitted
- 13 Aug 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auditory Cues on Mood and Gait
- ClinicalTrials.gov ID
- NCT05048576
- Acronym / sponsor ID
- 20-20.2
- Conditions
- Psychological, Auditory Perception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Clarkson UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive auditory cues | Experimental | Behavioral: Positive ReinforcementParticipants 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. |
| Negative auditory cues | Experimental | Behavioral: Negative ReinforcementParticipants 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. |
| Music | Experimental | Behavioral: MusicParticipants will be allowed to select a streaming music station of their choice. |
| Silence | Active comparator | Behavioral: SilenceParticipants will walk in silence while wearing noise cancelling headphones. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to stand without an assistive device
- Able to walk in 5-minute intervals over the duration of 63 minutes without assistive devices.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative ReinforcementTerms 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. | Behavioural | Negative auditory cues |
| Positive ReinforcementTerms 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. | Behavioural | Positive auditory cues |
| SilenceNo recordings will be played during this condition. | Behavioural | Silence |
| MusicParticipant's can choose their own music to play during this condition. | Behavioural | Music |
Primary outcome
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) 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) 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
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) 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
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 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
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 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
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
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Boolani, PhD principal investigator
Clarkson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Reinforcement, Positive Reinforcement and Silence in people with Psychological and Auditory Perception, run by Clarkson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Boolani, PhD (5043195828, aboolani@clarkson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.