HealthyNCT04227496
The Effect of Auditory Disturbances on Human Movement
A study testing Auditory disturbances in people with Healthy and Pain, run by University College of Northern Denmark at 1 site in Denmark.
Trial summary
This study sets out to investigate the potential effect of auditory disturbances on human movement Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Auditory disturbances
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pain free healthy participants
- Able to speak, read and understand Danish and English
- Self reported ongoing or recurring pain from neck, back, arm or leg
- Able to speak, read and understand Danish and English
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physiotherapy, University College of Northern Denmark
Aalborg, 9220
About this study
Official title: Evaluating the Effect of Auditory Disturbances on Human Movement
This study sets out to investigate the potential effect of auditory disturbances on human movement
Read the 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.
- Being tested
- Auditory disturbances
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory disturbancesDevice
A sound will be played from a portable device (smartphone) during movement
| Study group | Role | What they receive |
|---|---|---|
| Noise1 | Active comparator | A sound will be played while moving a body part through range of motion Receives: Device: Auditory disturbances |
| Noise2 | Active comparator | A sound (different from Noise 1) will be played while moving a body part through range of motion Receives: Device: Auditory disturbances |
| No noise | No intervention | No sound will be played while moving a body part through range of motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During a single test session (approximately 2hours)
Secondary outcomes (2)
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
Measured: During a single test session (approximately 2hours)
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
Measured: During a single test session (approximately 2hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start13 Jan 2020 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor
- Investigators
- Steffan WM Christensen, PhD, Principal investigator, Department of Physiotherapy, University College of Northern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227496
- Sponsor's protocol ID
- FOU-UU-2018-194_Sub-project1
- Status last verified
- Jan 2020
- First submitted
- 6 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Auditory Disturbances on Human Movement
- ClinicalTrials.gov ID
- NCT04227496
- Acronym / sponsor ID
- FOU-UU-2018-194_Sub-project1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 13 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Noise1 | Active comparator | Device: Auditory disturbancesA sound will be played while moving a body part through range of motion |
| Noise2 | Active comparator | Device: Auditory disturbancesA sound (different from Noise 1) will be played while moving a body part through range of motion |
| No noise | No intervention | –No sound will be played while moving a body part through range of motion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pain free healthy participants
- Able to speak, read and understand Danish and English
- Self reported ongoing or recurring pain from neck, back, arm or leg
- Able to speak, read and understand Danish and English
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory disturbancesA sound will be played from a portable device (smartphone) during movement | Device | Noise1, Noise2 |
Primary outcome
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)
2 secondary outcomes
Experienced pain
Time frame: During a single test session (approximately 2hours)
Experienced difficultness of performing movement
Time frame: During a single test session (approximately 2hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffan WM Christensen, PhD principal investigator
Department of Physiotherapy, University College of Northern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory disturbances in people with Healthy and Pain, run by University College of Northern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steffan WM Christensen, PhD (+45 72691009, sec@ucn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: During a single test session (approximately 2hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.