Utilizing EMG Shorts in Hip Population

NCT04720274 | Withdrawn FDA Device

• 1 other identifier: Pro00104994
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Injuries

Keywords

EMG Shorts; Hip Pain

Outcome Measures

Primary Outcomes (1)

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

  Up to 6 months

Secondary Outcomes (1)

• 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 Arms (2)

Participants with Hip Pain or Injuries

EXPERIMENTAL

Device: Electromyopathy (EMG) Shorts

Healthy Participants

ACTIVE COMPARATOR

Device: Electromyopathy (EMG) Shorts

Interventions

Electromyopathy (EMG) Shorts DEVICE

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

Healthy Participants; Participants with Hip Pain or Injuries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hip Injuries

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Richard Mather, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: September 4, 2023
• Primary Completion: June 1, 2024
• Study Completion: February 28, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)