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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Walkasins sensory neuroprosthesis to determine if it can aid older adults who have difficulty sensing their feet in walking better. The goal is to make walking feel more automatic and less mentally tiring by providing additional sensory feedback from the legs. Participants will perform walking tasks with the device both activated and deactivated to compare results. This trial suits older adults who have trouble feeling their feet but can still walk slowly and do not have serious health issues like heart problems or severe vision loss. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance mobility and quality of life for many.

Will I have to stop taking my current medications?

If you are currently taking medications that affect the central nervous system, such as benzodiazepines or anti-cholinergic medications, you will need to stop taking them to participate in this trial.

What prior data suggests that the Walkasins sensory neuroprosthesis is safe for older adults with foot sensory impairment?

Research has shown that the Walkasins sensory neuroprosthesis is a low-risk device, meaning it is generally safe and doesn't pose major risks to users. In earlier studies, people using Walkasins improved their walking balance and speed. Although some falls occurred, most did not require medical attention, suggesting the device is well-tolerated. Overall, the Walkasins device appears to be a safe choice for people with foot sensory issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Walkasins sensory neuroprosthesis because it offers a novel way to address sensory deficits in the lower limbs. Unlike traditional treatments, which often involve physical therapy or medication, Walkasins functions by delivering sensory feedback directly to the user, potentially enhancing balance and mobility. This neuroprosthesis is worn on the leg and uses sensory signals to compensate for the reduced sensation, which could lead to improved walking stability and safety. The innovative approach of using sensory feedback makes it a promising option for those who have not found relief with existing treatments.

What evidence suggests that the Walkasins sensory neuroprosthesis is effective for enhancing walking performance in older adults with foot sensory impairment?

Research has shown that the Walkasins device can help people with foot sensory issues walk and balance better. In this trial, participants will join different groups to evaluate the device's effectiveness. Studies have found that Walkasins improves walking speed and balance. Participants reported better walking ability and increased confidence in their balance. Some benefits appeared immediately and persisted with long-term use. Overall, Walkasins appears promising for enhancing mobility and making walking easier for older adults. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7680959/

The Effects of a Wearable Sensory Prosthesis on Gait and ... The walk2Wellness trial investigates effects of long-term, home-based daily use of a wearable sensory prosthesis on gait function, balance, quality of life and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06959277

Balance4Mobility: Effects of Walkasins Use in Individuals ... After 10 weeks of Walkasins use, this long-term study demonstrated clinically meaningful improvements in Functional Gait Assessment (FGA) and gait speed, which ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.655963/full

Long-Term Use of a Sensory Prosthesis Improves Function ... Improvements were seen immediately following donning the Walkasins® and the improvements continued throughout the 2 years follow-up while participating in the ...

4. rxfunction.com rxfunction.com/wp-content/uploads/2020/02/AP-10046v2_walk2Wellness_StudyUpdate_FEB2020.pdf

walk2Wellness Patients using Walkasins every day, who receive tactile sensory balance information, will improve outcomes of gait function, balance confidence, physical ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0216212

Neuromodulation to improve gait and balance function using a ... The current study investigated short-term effects of using Walkasins, an external lower-limb sensory neuroprosthesis, on clinical outcomes of balance and gait.

6. rxfunction.com rxfunction.com/wp-content/uploads/2024/08/Info_Prescibers_AP-10063_v6_0124.pdf

Walkasins Walkasins is a prescribed wearable sensory prosthetic device enabling patients with Sensory Peripheral Neuropathy to improve walking balance and decrease risk ...

7. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2022.931048/full

Extended effects of a wearable sensory prosthesis on gait, ... Non-significant improvements were observed in TUG and fast gait speed. Overall, 39 falls were reported; 31 of them did not require medical treatment and four ...