Utilizing EMG Shorts in Hip Population

Not Applicable

Withdrawn

• Conditions: Hip Injuries
• Interventions: Device: Electromyopathy (EMG) Shorts

• Registration Number: NCT04720274
• Lead Sponsor: Duke University

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-09-01
• Study Start: 2023-09-04
• Last Update Posted: 2023-09-06
• Primary Completion: 2024-06-01
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Participants	Electromyopathy (EMG) Shorts	-
Participants with Hip Pain or Injuries	Electromyopathy (EMG) Shorts	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States