The Effect of a Posture Shirt on Muscle Activity During F... | NCT03855124

Studies
The Effect of a Posture Shirt on Muscle Activity During Functional Tasks

NCT03855124

Sponsor

University College of Northern Denmark

Status

Unknown status

Last Update Posted

Mar 25, 2019Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Posture shirt

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2019Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Feb 13, 2019

First Submission Date that Met QC Criteria

Feb 24, 2019

First Posted Date

Feb 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2019

Last Update Posted Date

Mar 25, 2019Actual

Name	Class
Aalborg University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Device: Posture shirt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Posture shirt	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Electromyography (EMG)	EMG acitivty of axioscapular and trunk muscles will be recorded during upper limb tasks	During the test session

Secondary Outcomes

Measure	Description	Time Frame
Pain intensity: scale	Participants are to rate any perceived pain on a scale from 0-10 (0=no pain, 10= worst imaginable pain)	During the test session

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male participants

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

healthy male participants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Steffan W Christensen, PhD	Contact	+45 72691009		sec@ucn.dk

Overall Officials

Name	Affiliation	Role
Steffan W Christensen, PhD	Department of Physiotherapy, University College of Northern Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Physiotherapy, University College of Northern Denmark	Recruiting	Aalborg		9220	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided