Hip InjuriesNCT04720274
Utilizing EMG Shorts in Hip Population
A study testing Electromyopathy (EMG) Shorts in people with Hip Injuries, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Injuries
- What is being tested?
- Electromyopathy (EMG) Shorts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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.
- Conditions
- Hip Injuries
- Being tested
- Electromyopathy (EMG) Shorts
- Keywords
- EMG Shorts, Hip Pain
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyopathy (EMG) ShortsDevice
Participants will be asked to complete physical activities while wearing EMG shorts
| Study group | Role | What they receive |
|---|---|---|
| Participants with Hip Pain or Injuries | Experimental | Not described Receives: Device: Electromyopathy (EMG) Shorts |
| Healthy Participants | Active comparator | Not described Receives: Device: Electromyopathy (EMG) Shorts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of muscle activation while preforming physical therapy exercises in a post operative setting as measured EMG shorts.
Measured: Up to 6 months
Secondary outcomes (1)
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.
Measured: End of study, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start4 Sep 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Why it stopped: Principal Investigator decided to not open the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Mather, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720274
- Sponsor's protocol ID
- Pro00104994
- Status last verified
- Aug 2023
- First submitted
- 19 Jan 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing EMG Shorts to Access Hip Injuries and Recovery After Surgery
- ClinicalTrials.gov ID
- NCT04720274
- Acronym / sponsor ID
- Pro00104994
- Conditions
- Hip Injuries
- Keywords
- EMG Shorts, Hip Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator decided to not open the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Sep 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Hip Pain or Injuries | Experimental | Device: Electromyopathy (EMG) Shorts |
| Healthy Participants | Active comparator | Device: Electromyopathy (EMG) Shorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyopathy (EMG) ShortsParticipants will be asked to complete physical activities while wearing EMG shorts | Device | Healthy Participants, Participants with Hip Pain or Injuries |
Primary outcome
Amount of muscle activation while preforming physical therapy exercises in a post operative setting as measured EMG shorts.
Time frame: Up to 6 months
1 secondary outcome
Percent of participants that stated a positive experience with EMG shorts as measured by patient satisfaction survey.
Time frame: End of study, up to one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Mather, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyopathy (EMG) Shorts in people with Hip Injuries, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of muscle activation while preforming physical therapy exercises in a post operative setting as measured EMG shorts. (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.