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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT05736393
Eligibility Criteria:
Inclusion Criteria:
* Age 18-70
* Diagnosis of LBP by licensed medical provider or self-report of lower back pain (initially gathered through partial HIPAA waiver, and confirmed during in-person screening visit)
* Self-reported LBP with bending or lifting
* Able to walk without an assistive device.
* Willing and able to provide informed consent.
* Provide HIPAA Authorization to allow communication with the primary healthcare provider (e.g., treating physical therapist) for communication (as needed) during the study period.
* Must undergo physical therapy examination with research physical therapist and be assigned a Treatment-Based Classification (TBC) of movement impairment or control impairment.
Exclusion Criteria:
* Unable to attend all scheduled visits and 1-month phone follow-up
* Currently pregnant or likely to become pregnant within 6 weeks
* Having received surgery to address current LBP
* Having pain or symptoms below the knee that seems related to their current LBP
* Having current LBP lasting less than 2 weeks
* Diagnosed or self-reported neurological disorders effecting motor control (stroke, Parkinson's disease, etc.)
* Use of a pacemaker or other implanted medical devices
* Currently under treatment for cancer
* Skin issues / sensitivity that an exosuit could exacerbate (e.g., Epidermolysis Bullosa)
* Any other medical conditions that would preclude safe use of the exosuit device as determined by a physical therapist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05736393
Study Brief:
Protocol Section:
NCT05736393