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Utilizing EMG Shorts in Hip Population

Primary Purpose

Hip Injuries

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electromyopathy (EMG) Shorts

About this trial

This is an interventional basic science trial for Hip Injuries focused on measuring EMG Shorts, Hip Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Participants with Hip Pain or Injuries

Healthy Participants

Arm Description

Outcomes

Primary Outcome Measures

Amount of muscle activation while preforming physical therapy exercises in a post operative setting as measured EMG shorts.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04720274

First Posted

January 19, 2021

Last Updated

September 1, 2023

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT04720274

Brief Title

Utilizing EMG Shorts in Hip Population

Official Title

Utilizing EMG Shorts to Access Hip Injuries and Recovery After Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Principal Investigator decided to not open the study.

Study Start Date

September 4, 2023 (Anticipated)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Injuries

Keywords

EMG Shorts, Hip Pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants with Hip Pain or Injuries

Arm Type

Experimental

Arm Title

Healthy Participants

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Electromyopathy (EMG) Shorts

Intervention Description

Participants will be asked to complete physical activities while wearing EMG shorts

Primary Outcome Measure Information:

Title

Amount of muscle activation while preforming physical therapy exercises in a post operative setting as measured EMG shorts.

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Percent of participants that stated a positive experience with EMG shorts as measured by patient satisfaction survey.

Description

Study team developed survey, one to two question survey about experience.

Time Frame

End of study, up to one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Mather, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Utilizing EMG Shorts in Hip Population

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