Utilizing EMG Shorts in Hip Population | NCT04720274

Studies
Utilizing EMG Shorts in Hip Population

NCT04720274

Sponsor

Duke University

Status

Withdrawn

Last Update Posted

Sep 6, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hip Injuries

Interventions

Electromyopathy (EMG) Shorts

Countries

United States

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator decided to not open the study.

Expanded Access Info

Start Date

Sep 4, 2023Estimated

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Feb 28, 2025Estimated

First Submitted Date

Jan 19, 2021

First Submission Date that Met QC Criteria

Jan 19, 2021

First Posted Date

Jan 22, 2021Actual

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

Sep 1, 2023

Last Update Posted Date

Sep 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to use a combination of electromyopathy (EMG) shorts and muscle monitoring software to collect data from participants performing physical exercises in order to determine the combination's diagnostic efficacy and ability to provide rehabilitative guidance for people who are recovering from hip injuries. Both healthy volunteers and Duke Patients seeking treatment for their hip pain and/or injuries will be enrolled in our research. If participants choose to take part they will be asked to wear these EMG shorts and perform various exercises like running on a treadmill, riding a stationary bike, or lifting weights.

Participation in this study consists of one study visit for healthy volunteers, but will last up to six months for Duke Patients. At each standard of care clinic visit throughout six months, Duke Patients will be asked to also come in for a study visit, wear the EMG shorts, and perform the same exercises preformed during the first study visit.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants with Hip Pain or Injuries	Experimental		Device: Electromyopathy (EMG) Shorts
Healthy Participants	Active Comparator		Device: Electromyopathy (EMG) Shorts

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electromyopathy (EMG) Shorts	Device	Participants will be asked to complete physical activities while wearing EMG shorts	Healthy Participants Participants with Hip Pain or Injuries

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of muscle activation while preforming physical therapy exercises in a post operative setting as measured EMG shorts.		Up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Percent of participants that stated a positive experience with EMG shorts as measured by patient satisfaction survey.	Study team developed survey, one to two question survey about experience.	End of study, up to one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion (Duke Patients):

All subjects must be 18 years of age or older.
Any patient that currently has hip pain or injury and is seeking treatment from either Dr. Mather, Dr. Lewis, or Dr. Olson, within the hip preservation clinics.
Subjects must be able to fit into the shorts in order to participate.

Inclusion (Healthy Volunteers):

All healthy volunteer subjects must be 18 years of age or older.
Subjects must be able to fit into the shorts in order to participate.

Exclusion Criteria:

Exclusion (Duke Patients):

Any recent lower extremity injury (such as an ankle sprain/surgery or knee surgery).
Patient is unable to provide written consent, or patient is unable to speak, write, or understand English.
Pregnant women (Verbal Confirmation)
Allergic or hypersensitivity to laminate material.

Exclusion (Healthy Volunteers):

Any recent lower extremity injury (such as an ankle sprain/surgery or knee surgery).
Prior hip surgery, or current hip injury, surgery, or pain.
Patient is unable to provide written consent, or patient is unable to speak, write, or understand English.
Pregnant women (Verbal Confirmation)
Allergic or hypersensitivity to laminate material.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Richard Mather, MD	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D004568	Electrodiagnosis
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D009213	Myography