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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT03538756
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-90 years, male or female
* Formal diagnosis of sensory peripheral neuropathy prior to participating in the study
* Self-reported balance problems
* Ability for transfers or ambulation on level surfaces at fixed cadence as assessed by the physical therapist during the FGA
* FGA \<23, the cut-off score for high fall-risk
* Ability to understand and provide informed consent
* Foot size that allows Walkasins® to function appropriately
* Must be able to complete all functional outcome measures without the use of an assistive device
Exclusion Criteria:
* Inability to perceive vibration from Walkasins leg unit
* Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
* Acute thrombophlebitis including deep vein thrombosis
* Untreated lymphedema
* Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
* Untreated fractures in the foot and ankle
* Severe peripheral vascular disease
* Musculoskeletal or other neurological conditions that prohibit use of Walkasins as determined by clinician
* Weighs more than 300 pounds
* Plans to begin balance physical therapy (PT) during the first ten weeks of the clinical trial (Ongoing or previous balance PT is not an exclusionary criterion.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03538756
Study Brief:
Protocol Section:
NCT03538756