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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04227496
Other study ID # FOU-UU-2018-194_Sub-project1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 13, 2020
Est. completion date December 31, 2023

Study information

Verified date January 2020
Source University College of Northern Denmark
Contact Steffan WM Christensen, PhD
Phone +45 72691009
Email sec@ucn.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Auditory disturbances
A sound will be played from a portable device (smartphone) during movement

Locations

Country Name City State
Denmark Department of Physiotherapy, University College of Northern Denmark Aalborg

Sponsors (2)

Lead Sponsor Collaborator
University College of Northern Denmark Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 During a single test session (approximately 2hours)
Secondary 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
During a single test session (approximately 2hours)
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