Utilizing EMG Shorts in Hip Population

NCT ID: NCT04720274

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-04
• Study Completion Date: 2025-02-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Participants with Hip Pain or Injuries

Group Type: EXPERIMENTAL

Electromyopathy (EMG) Shorts

Intervention Type: DEVICE

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

Healthy Participants

Group Type: ACTIVE_COMPARATOR

Electromyopathy (EMG) Shorts

Intervention Type: DEVICE

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

Interventions

Electromyopathy (EMG) Shorts

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Mather, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00104994

Identifier Type: -

Identifier Source: org_study_id