Neuroprosthesis for Sensory Deficits

Overseen By Shravani Chobhe

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Benzodiazepines, Anticholinergics, GABAergics, others

Disqualifiers: Neurological disorders, Severe arthritis, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for older adults aged 65-95 with foot sensory impairments and slow walking speeds, but without severe high blood pressure, vision impairment, cognitive issues (MoCA score ≥ 26), or any major health conditions that could affect walking. Participants must not be enrolled in other trials or planning to move away during the study.

Inclusion Criteria

No cognitive impairment: Montreal Cognitive Assessment (MoCA) score ≥ 26 out of 30 possible points

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

Exclusion Criteria

Uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)

Current enrollment in any other clinical trial

Planning to relocate out of the area during the study period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo complex walking performance assessments with Walkasins in both 'on' and 'off' settings

2 weeks

2 visits (in-person, at least one week apart)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Walkasins sensory neuroprosthesis

Trial Overview The study tests if Walkasins sensory neuroprosthesis can improve complex walking tasks by enhancing automaticity and reducing cognitive demand in walking among seniors with foot sensory deficits. It compares active devices against inactive ones measuring brain activity, dual-task costs, and gait variability.

Participant Groups

Group I: Active lower-limb neuroprosthesis Active Control 1 Intervention

Participants will perform single- and dual-task walking trials, including Serial 7 Subtraction, with and without navigating wide and high obstacles (to increase cognitive effort), while wearing Walkasins in "ON" setting

Group II: Inactive lower-limb neuroprosthesis Placebo Group 1 Intervention

Participants will perform single- and dual-task walking trials, including Serial 7 Subtraction, with and without navigating wide and high obstacles (to increase cognitive effort), while wearing Walkasins in "OFF" setting

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

The Claude D. Pepper Older Americans Independence Centers

Collaborator

Trials

11

Recruited

350+