NCT04227496

Brief Summary

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

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
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable healthy

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

First Submitted

Initial submission to the registry

January 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

January 6, 2020

Last Update Submit

January 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    During a single test session (approximately 2hours)

Secondary Outcomes (2)

  • Experienced pain

    During a single test session (approximately 2hours)

  • Experienced difficultness of performing movement

    During a single test session (approximately 2hours)

Study Arms (3)

Noise1

ACTIVE COMPARATOR

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

Device: Auditory disturbances

Noise2

ACTIVE COMPARATOR

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

Device: Auditory disturbances

No noise

NO INTERVENTION

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

Interventions

A sound will be played from a portable device (smartphone) during movement

Noise1Noise2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiotherapy, University College of Northern Denmark

Aalborg, 9220, Denmark

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steffan WM Christensen, PhD

    Department of Physiotherapy, University College of Northern Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steffan WM Christensen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 13, 2020

Study Start

January 13, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations