search
Back to results

The Effect of Auditory Disturbances on Human Movement

Primary Purpose

Healthy, Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Auditory disturbances
Sponsored by
University College of Northern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Physiotherapy, University College of Northern Denmark

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Noise1

Noise2

No noise

Arm Description

A sound will be played while moving a body part through range of motion

A sound (different from Noise 1) will be played while moving a body part through range of motion

No sound will be played while moving a body part through range of motion

Outcomes

Primary Outcome Measures

Range of motion
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)

Secondary Outcome Measures

Experienced pain
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
Experienced difficultness of performing movement
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

Full Information

First Posted
January 6, 2020
Last Updated
January 10, 2020
Sponsor
University College of Northern Denmark
Collaborators
Aalborg University
search

1. Study Identification

Unique Protocol Identification Number
NCT04227496
Brief Title
The Effect of Auditory Disturbances on Human Movement
Official Title
Evaluating the Effect of Auditory Disturbances on Human Movement
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 13, 2020 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College of Northern Denmark
Collaborators
Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Noise1
Arm Type
Active Comparator
Arm Description
A sound will be played while moving a body part through range of motion
Arm Title
Noise2
Arm Type
Active Comparator
Arm Description
A sound (different from Noise 1) will be played while moving a body part through range of motion
Arm Title
No noise
Arm Type
No Intervention
Arm Description
No sound will be played while moving a body part through range of motion
Intervention Type
Device
Intervention Name(s)
Auditory disturbances
Intervention Description
A sound will be played from a portable device (smartphone) during movement
Primary Outcome Measure Information:
Title
Range of motion
Description
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)
Time Frame
During a single test session (approximately 2hours)
Secondary Outcome Measure Information:
Title
Experienced pain
Description
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
Time Frame
During a single test session (approximately 2hours)
Title
Experienced difficultness of performing movement
Description
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
Time Frame
During a single test session (approximately 2hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steffan WM Christensen, PhD
Phone
+45 72691009
Email
sec@ucn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffan WM Christensen, PhD
Organizational Affiliation
Department of Physiotherapy, University College of Northern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physiotherapy, University College of Northern Denmark
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Auditory Disturbances on Human Movement

We'll reach out to this number within 24 hrs