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:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT02065518
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of knee injury (internal derangement of the knee with new effusion, including knee sprain or strains, meniscal tear, cruciate ligamentous tear, and chondral flap or injury);
* A diagnosis of knee pain that is anterior knee pain, overuse pain, patella-femoral pain, and chronic pain (less than 6 months) associated with overuse syndromes which negatively impacts performance by (a) pain in 1 or both knees on most days of the month; b) self reported difficulty performing at least one or more tasks due to pain: stair climbing, rising from a chair, walking or running a quarter mile, repetitive movements such as kneeling or squatting or stooping, pain that inhibits job performance and daily activities;
* Military service member at the time of injury (active duty military and Reserve/ National Guard in active duty status);
* Age ≥18 and ≤50 years;
* Ability to provide freely given informed consent.
Exclusion Criteria:
* Fracture or injury to external knee structures such that knee extension or flexion is impaired;
* Evidence of a fracture on radiographs or clinical evidence of unstable tendon tear/rupture;
* A significant co-morbid medical condition (such as severe hypertension or neurological disorder in which NMES strength training or unsupervised exercise is contraindicated and would pose a safety threat or impair ability to participate;
* Inability or unwillingness to participate in a walking or strengthening program;
* Inability to speak and/or read English;
* Reduced sensory perception in the lower extremities;
* Inability to walk on a treadmill without an assistive device;
* Vision impairment, where participant is classified as legally blind;
* Unwillingness to accept random assignment;
* Pregnancy;
* A score of 23 or greater on the Center for Epidemiological Studies- Depression scale (CES-D);
* If the person has a demand type implanted pacemaker or defibrillator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02065518
Study Brief:
Protocol Section:
NCT02065518