BridgeMD
New treatment option for Aging
Official title Walking Sensation Study
ClinicalTrials.gov ID: NCT06975423
What this study is testing
- What it's testing
- 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 walking task in older adults with foot sensory impairment. The overarching hypothesis is that Walkasins will enhance the automaticity and reduce cognitive demand of walking in older adults with foot sensory impairments, as measured by reduced prefrontal activity, decreased dual-task costs, and lower gait variability.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 95. Healthy volunteers may be eligible.
You may be able to join if
- Not having any significant existing medical conditions, historical health issues, or medications (outlined in the
You likely can't join if
- 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.
See the full eligibility criteria
- Not having any significant existing medical conditions, historical health issues, or medications (outlined in the
- 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 Criteria:
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 95 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.