Status:
RECRUITING
Walking Sensation Study
Lead Sponsor:
University of Florida
Collaborating Sponsors:
The Claude D. Pepper Older Americans Independence Centers
Conditions:
Aging
Sensory Deficit
Eligibility:
All Genders
65-95 years
Phase:
NA
Brief Summary
The primary objective of this new line of research is to test whether augmenting sensory information from the legs, using Walkasins sensory neuroprosthesis, can enhance performance of a complex walkin...
Detailed Description
Preserving mobility function in older adults is crucial for ensuring safe walking in complex environments, including home and community settings. A common example is navigating a busy street with obst...
Eligibility Criteria
Inclusion
- Not having any significant existing medical conditions, historical health issues, or medications (outlined in the exclusion criteria table above) that could impede the execution of the walking task and assessment.
- age 65 - 95.
- no severe high blood pressure (systolic \< 180 mmHg and/or diastolic \< 100 mmHg at rest).
- no severe vision impairment: visual acuity ≥ 20/70 as determined by Snellen eye chart.
- slow walking speed: preferred walking speed slower than 1.0 m/s over 10 meter.
- no cognitive impairment: Montreal Cognitive Assessment (MoCA) score ≥ 26 out of 30 possible points.
- foot sensory impairment: Inability to feel the 10 g monofilament at ≥1 of 10 tested sites on either foot is considered a sign of impaired protective sensation. loss.
Exclusion
- diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (Alzheimer's, Parkinson's, stroke, etc.)
- severe arthritis, such as awaiting joint replacement
- current cardiovascular, lung or renal disease; untreated diabetes; terminal illness
- myocardial infarction or major heart surgery in the previous year
- cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
- current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- currently taking medications that affect the central nervous system, such as benzodiazepines, anti-cholinergic medication, and GABAergic medication, among others
- no severe vision impairment (visual acuity ≥ 20/70 as determined by Snellen eye chart)
- uncontrolled hypertension at rest (systolic \> 180 mmHg and/or diastolic \> 100 mmHg)
- bone fracture or joint replacement in the previous six months
- current enrollment in any other clinical trial
- planning to relocate out of the area during the study period
- non-English\* speaking, due to the likelihood of difficulties following instructions and communicating remotely
- clinical judgment of the investigative team
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06975423
Start Date
September 8 2025
End Date
March 31 2027
Last Update
December 8 2025
Active Locations (1)
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1
Clinical and Translational Research Building
Gainesville, Florida, United States, 32610