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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT07127133
Eligibility Criteria:
Inclusion Criteria:
* Age 55 or older
* Ability to ambulate without the use of an assistive device. For this study, we will assume participants are ambulatory if they can complete the functional outcome measures (i.e., TUG) without the use of an assistive device
* Ability to understand and provide informed consent, or has a legally authorized representative (LAR) to provide consent on their behalf
* Ability to don and doff the insole and leg module independently or have assistance for the duration of the study
Exclusion Criteria:
* Non-English Speaking
* Use of ankle-foot orthosis for ambulation that prevents use of the system
* Self-reported acute thrombophlebitis including deep vein thrombosis
* Untreated lymphedema or lesion of any kind, swelling, infection, inflamed area of skin or eruptions on or near product use (foot and ankle)
* Untreated fractures in the foot and ankle
* Any other significant medical condition that may affect participation or performance in the study, as determined by investigators
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT07127133
Study Brief:
Protocol Section:
NCT07127133