HealthyNCT03855124
The Effect of a Posture Shirt on Muscle Activity During Functional Tasks
An observational study of Healthy, run by University College of Northern Denmark at 1 site in Denmark.
Trial summary
This study sets out to investigate the effect of a posture shirt on muscle activity during a sitting and standing repetitive upper limb task Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Posture shirt
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Mar 2019to 31 Dec 2019
- Phase
- Observational
- 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
- Men only
- Healthy volunteers accepted
- Adult
Study population: healthy male participants
Who may be able to join
- Pain free healthy participants
- Able to speak, read and understand Danish
Who cannot join
- Pain from the back, neck or shoulder area during the past 6 months
- Experience of delayed onset muscle soreness (DOMS) on the day of testing
- Current or previous chronic or recurrent pain condition
- Regular use of analgesics
- Previous neurologic, musculoskeletal or mental illnesses that may influence the results
- Lack of ability to cooperate
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Physiotherapy, University College of Northern Denmark
Aalborg, 9220
Steffan W Christensen, PhD, +45 72691009, sec@ucn.dk
About this study
This study sets out to investigate the effect of a posture shirt on muscle activity during a sitting and standing repetitive upper limb task
Read the detailed description
Posture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle activity, reduce musculoskeletal pain and discomfort. This study sets out to investigate the effect of a posture shirt on muscle activity during a sitting and a standing repetitive upper limb task.
- Conditions
- Healthy
- Being tested
- Posture shirt
- Keywords
- Electromyography, Musculoskeletal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posture shirtDevice
Posture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle actitity, reduce musculoskeletal pain and discomfort.
| Study group | Role | What they receive |
|---|---|---|
| healthy participants | Participants will be ask to perform a repetitive upper limb task while posture and muscle activity is being monitored.This will be done while wearing a posture shirt or without a shirt Receives: Device: Posture shirt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography (EMG)
EMG acitivty of axioscapular and trunk muscles will be recorded during upper limb tasks
Measured: During the test session
Secondary outcomes (1)
Pain intensity: scale
Participants are to rate any perceived pain on a scale from 0-10 (0=no pain, 10= worst imaginable pain)
Measured: During the test session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start21 Mar 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 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 W Christensen, PhD, Principal investigator, Department of Physiotherapy, University College of Northern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855124
- Sponsor's protocol ID
- FOU-UU-2018-12_Sub-project2
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Posture Shirt on Muscle Activity During Functional Tasks
- ClinicalTrials.gov ID
- NCT03855124
- Acronym / sponsor ID
- FOU-UU-2018-12_Sub-project2
- Conditions
- Healthy
- Keywords
- Electromyography, Musculoskeletal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Feb 2019 (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 effect of a posture shirt on muscle activity during a sitting and standing repetitive upper limb task
Detailed description
Posture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle activity, reduce musculoskeletal pain and discomfort. This study sets out to investigate the effect of a posture shirt on muscle activity during a sitting and a standing repetitive upper limb task.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy participants | – | Device: Posture shirtParticipants will be ask to perform a repetitive upper limb task while posture and muscle activity is being monitored.This will be done while wearing a posture shirt or without a shirt |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy male participants
Key inclusion criteria (2 listed)
- Pain free healthy participants
- Able to speak, read and understand Danish
Key exclusion criteria (6 listed)
- Pain from the back, neck or shoulder area during the past 6 months
- Experience of delayed onset muscle soreness (DOMS) on the day of testing
- Current or previous chronic or recurrent pain condition
- Regular use of analgesics
- Previous neurologic, musculoskeletal or mental illnesses that may influence the results
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 |
|---|---|---|
| Posture shirtPosture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle actitity, reduce musculoskeletal pain and discomfort. | Device | healthy participants |
Primary outcome
Electromyography (EMG)
Time frame: During the test session
EMG acitivty of axioscapular and trunk muscles will be recorded during upper limb tasks
1 secondary outcome
Pain intensity: scale
Time frame: During the test session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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 W 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?
An observational study of Healthy, 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 2 inclusion and 6 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 25 Mar 2019. 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 W 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?
Electromyography (EMG) (time frame: During the test session). 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 25 Mar 2019.