The Effect of Auditory Disturbances on Human Movement

January 10, 2020 updated by: University College of Northern Denmark

Evaluating the Effect of Auditory Disturbances on Human Movement

This study sets out to investigate the potential effect of auditory disturbances on human movement

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Clinicians routinely investigate/test human movement but if/how this is effect by auditory disturbances is unclear. This study sets out to investigate the impact of auditory disturbances on human movement.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Steffan WM Christensen, PhD
  • Phone Number: +45 72691009
  • Email: sec@ucn.dk

Study Locations

  • Denmark
      • Aalborg, Denmark, 9220
        • Department of physiotherapy, University College of Northern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Criteria:

Inclusion Criteria: - Healthy participants

  • Pain free healthy participants
  • Able to speak, read and understand Danish and English

Exclusion Criteria: - Healthy participants

  • Pain from the neck, back, arm or leg during the past 6 months up to the test session
  • Former surgery in neck, back, arm or leg restricting normal movement
  • Current or previous chronic or recurrent pain condition
  • Pregnancy
  • Current or previous neurologic, musculoskeletal or mental illnesses
  • Lack of ability to cooperate

Inclusion Criteria: - Pain population

  • Self reported ongoing or recurring pain from neck, back, arm or leg
  • Able to speak, read and understand Danish and English

Exclusion Criteria: - Neck pain population

  • Current or previous chronic or recurrent pain condition
  • Former surgery in neck, back, arm or leg restricting normal movement
  • Pregnancy
  • Current or previous neurologic, musculoskeletal (other than what is included) or mental illnesses
  • Lack of ability to cooperate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Noise1
A sound will be played while moving a body part through range of motion
Device: Auditory disturbances
A sound will be played from a portable device (smartphone) during movement
Active Comparator: Noise2
A sound (different from Noise 1) will be played while moving a body part through range of motion
Device: Auditory disturbances
A sound will be played from a portable device (smartphone) during movement
No Intervention: No noise
No sound will be played while moving a body part through range of motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: During a single test session (approximately 2hours)
Range of movement will be assessed by measuring displacement of the body part being moved (i.e. moving the head, back, arm or leg from a neutral position to end of range in flexion, extension, rotation, addiction or abduction)
During a single test session (approximately 2hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experienced pain
Time Frame: During a single test session (approximately 2hours)
Any potential pain during the functional tasks will be monitored using a 0-11 numeric rating scale (NRS) with 0 being no pain and 10 being worst imaginable pain
During a single test session (approximately 2hours)
Experienced difficultness of performing movement
Time Frame: During a single test session (approximately 2hours)

a 6-point Likert scale going from 0 = 'no problems',

1 = minimally difficult; 2 = somewhat difficult; 3 = fairly difficult; 4 = very difficult; 5 = unable to perform
During a single test session (approximately 2hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College of Northern Denmark

Collaborators

Aalborg University

Investigators

  • Principal Investigator: Steffan WM Christensen, PhD, Department of physiotherapy, University College of Northern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 13, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOU-UU-2018-194_Sub-project1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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