Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT04060251
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* Owns a device with internet connection
* Can download the E-vive application for the contractile garment (has sufficiently up-to-date phone or tablet, or has family member with such a device).
* Has a rudimentary understanding of Internet technology, especially e-mail
* Has a flexion of 90 o and flexion contracture of 5 o at the point of discharge
* Approved by a physical therapist to participate safely in the study at the time of discharge
Exclusion Criteria:
* Rheumatoid arthritis
* History of epilepsy
* Implanted and body-worn electronic medical device, including cardiac pacemakers, neural stimulators, insulin pumps, etc.
* Poor understanding of the use of the brace/electrical stimulation
* Lesions on the skin over the thigh
* Uncontrolled diabetes
* Uncontrolled hypertension
* Bilateral TKA or UKA planned
* If female, pregnant
* Cannot use non-operated leg postoperatively to propel active motion splint, caused by neurological or muscular diseases such as complete or incomplete paralysis or other causes of weakness with an inability to bend or extend knee
* Loss of sensation in operated or non-operated leg
* Has below- or above-knee amputations of non-operative leg
* Below- knee amputation of operated side
* Chronic pain syndrome with inability to walk
* Taking chronic narcotics and/or is taking more than 10mg codeine per day, or any Hydrocodone, or more than 200 mg of tramadol, or any other narcotics prescribed for moderate to severe pain
* Involved in pain clinics for chronic pain, or pain that is not related to the knee
* Has been diagnosed with knee disorder other than osteoarthritis, post-traumatic osteoarthritis, gout, pseudo gout, or any inability to walk due to disorders unrelated to the knee (e.g., hip disorders, spinal stenosis, paralysis, hemi-paralysis)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04060251
Study Brief:
Protocol Section:
NCT04060251