Utilizing EMG Shorts in Hip Population

Utilizing EMG Shorts to Access Hip Injuries and Recovery After Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Hip Injuries
• Intervention / Treatment: Device: Electromyopathy (EMG) Shorts

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JaNell Dupree, MPH; Phone Number: 919-660-4025; Email: janell.wylie@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Participants	Device: Electromyopathy (EMG) Shorts; Participants will be asked to complete physical activities while wearing EMG shorts
Experimental: Participants with Hip Pain or Injuries	Device: Electromyopathy (EMG) Shorts; Participants will be asked to complete physical activities while wearing EMG shorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Richard Mather, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): September 4, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Hip Pain; EMG Shorts
• Additional Relevant MeSH Terms: Wounds and Injuries; Hip Injuries
• Other Study ID Numbers: Pro00104994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No