Clinical trial NCT04720274: Utilizing EMG Shorts in Hip Population
Official title: Utilizing EMG Shorts to Access Hip Injuries and Recovery After Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hip Injuries
Keywords: EMG Shorts
Hip Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Amount of muscle activation while preforming physical therapy exercises in a post operative setting as measured EMG shorts.
timeFrame: Up to 6 months
Secondary outcomes:
measure: Percent of participants that stated a positive experience with EMG shorts as measured by patient satisfaction survey.
timeFrame: End of study, up to one year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Richard Mather, MD
role: PRINCIPAL_INVESTIGATOR
References: