NCT06028308

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Aug 2023Sep 2026

First Submitted

Initial submission to the registry

August 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

August 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

September 8, 2023

Status Verified

August 1, 2023

Enrollment Period

3.1 years

First QC Date

August 22, 2023

Last Update Submit

August 31, 2023

Conditions

WhiplashHealthy

Keywords

WhiplashNeck painKinematics

Outcome Measures

Primary Outcomes (1)

  • Range of motion

    Range of motion will be assessed during head rotations (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position)

    During a single test session (approximately 45minutes) at day 1

Secondary Outcomes (5)

  • Head repositioning accuracy

    During a single test session (approximately 45minutes) at day 1

  • Quality of head movement

    During a single test session (approximately 45minutes) at day 1

  • Perceived stiffness during movement

    During a single test session (approximately 45minutes) at day 1

  • Perceived difficultness of performing movement

    During a single test session (approximately 45minutes) at day 1

  • Perceived neck pain intensity

    During a single test session (approximately 45minutes) at day 1

Other Outcomes (4)

  • Neck Disability Index (NDI)

    At the beginning of the single test session (approximately 45minutes) at day 1

  • Tampa Scale for Kinesiophobia (TSK-11)

    At the beginning of the single test session (approximately 45minutes) at day 1

  • Perceived area of neck pain

    At the beginning of the single test session (approximately 45minutes) at day 1

  • +1 more other outcomes

Study Arms (3)

Sound 1

EXPERIMENTAL

A sound will be played while moving the head

Device: Smartphone playing a sound

Sound 2

EXPERIMENTAL

A sound (different from Sound 1) will be played while moving the head

Device: Smartphone playing a sound

No Sound

NO INTERVENTION

No sound will be played while moving the head

Interventions

Smartphone playing a soundDEVICE

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

Sound 1Sound 2

Eligibility Criteria

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

You may qualify if:

  • Able to speak, read and understand Danish/English

You may not qualify if:

  • Pain from the neck or shoulder area during the past 6 months
  • Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session
  • Former surgery in neck or shoulder
  • Current or previous chronic or recurrent pain condition that could affect the results
  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, musculoskeletal or mental illnesses that could affect the results
  • Regular use of analgesics
  • Abnormally disrupted sleep in the last 24 hours preceding the experiment
  • Lack of ability to cooperate
  • Neck pain group:
  • Traumatic onset of neck pain
  • Able to speak, read and understand Danish/English
  • Experience of DOMS during the week leading up to the test session
  • Former surgery in neck or shoulder
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

FysioDanmark Aalborg

Aalborg, 9000, Denmark

Location

Dept. Of Health Science and Technology, Aalborg University

Gistrup, 9260, Denmark

Location

MeSH Terms

Conditions

Whiplash InjuriesNeck Pain

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steffan WM Christensen, PhD

    Aalborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steffan WM Christensen, PhD

CONTACT

(+45) 99408889stc@hst.aau.dk

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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 22, 2023

First Posted

September 8, 2023

Study Start

August 31, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

September 8, 2023

Record last verified: 2023-08

Locations

DK(2)