Utilizing EMG Shorts in Hip Population

Hip Injuries Clinical Trial

Official title:

Utilizing EMG Shorts to Access Hip Injuries and Recovery After Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04720274
• Other study ID #: Pro00104994
• Status: Withdrawn
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 28, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Injuries

Intervention

Device:
• Electromyopathy (EMG) Shorts
Participants will be asked to complete physical activities while wearing EMG shorts

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of muscle activation while preforming physical therapy exercises in a post operative setting as measured EMG shorts.		Up to 6 months
Secondary	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