Clinical trial NCT06959277: Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems
Official title: Balance4Mobility: Effects of Walkasins Use on Clinical Outcomes of Gait and Balance Function in Individuals With Peripheral Neuropathy and Balance Problems - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Neuropathies
Peripheral Neuropathy Due to Chemotherapy
Peripheral Neuropathy With Type 2 Diabetes
Balance Control in Elderly
Gait Disorders
Keywords: Walkasins
Peripheral Neuropathy
Balance Problems
Lead sponsor: RxFunction Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group participants will receive Walkasins after six months of taking part in the trial.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. The main question it aims to answer is whether participants who use Walkasins on an everyday basis over a six-month period will report better awareness of their foot placement on the ground.

Researchers will compare Walkasins users to a control group of participants who are not using Walkasins to see if the device improves the users' performance on some standing and walking tests. Control group participants will get Walkasins after six months of being in the study.

During the study participants will be asked to do the following:

* Answer questions about their medical history and balance.
* Do some standing and walking tests. Some of the tests will be timed.
* Attend study visits and participate in study phone calls.
* Keep track of any falls and notify study staff if they fall.
* Wear the Walkasins device on a regular basis.

Detailed description: A randomized cross-over study of short-term, in-clinic effects of Walkasins use, conducted at the Minneapolis Veterans Affairs Medical Center (VAMC) and published in PLOS ONE, found clinically meaningful and statistically significant improvements in gait speed and functional balance in patients with SPN using Walkasins. The authors stated that "findings suggest new sensory balance cues provided to the lower limb can modulate the activity of relevant nerve afferents and become integrated into sensorimotor control of balance and gait."

In 2020 a multi-site clinical trial of the long-term effects of daily Walkasins use (walk2Wellness, ClinicalTrials.gov #NCT03538756) was published in Frontiers in Aging Neuroscience. After 10 weeks of Walkasins use, this long-term study demonstrated clinically meaningful improvements in Functional Gait Assessment (FGA) and gait speed, which is associated with a lower fall risk. The authors concluded that "a wearable sensory prosthesis may provide a new way to treat gait and balance problems and manage falls in high fall-risk patients with PN."

Most recently, an analysis of data from 26 weeks of Walkasins use in the walk2Wellness trial showed that "participants who reported falls over 6 months prior to the study had a 43% decrease in fall rate during the study as compared to self-report 6-month pre-study (11.8 vs. 6.7 falls/1000 patient days, respectively, p \<0.004), similar to the 46% decrease reported after 10 weeks of use."

The present study involves an assessment of Walkasins through a randomized, controlled trial with a primary endpoint of 26 weeks. Furthermore, this study will enroll only individuals 55 and older with a goal of including participants that reflect the Medicare population to support payer reimbursement for Walkasins.

The objectives of this study are as follows:

* Reflect real-world use of Walkasins in a Medicare-representative population who have sensory peripheral neuropathy and associated gait and balance problems and who would be eligible for a prescription to use the device.
* Investigate the impact of Walkasins use on relevant clinical outcomes associated with gait and physical function.
* Demonstrate based on patient reporting that Walkasins improves awareness of foot placement on the ground indicating partial replacement of plantar mechanoreceptor function, lost due to peripheral neuropathy.
* Investigate whether plantar monofilament testing at levels \<10g (5.07, LOPS) are associated with gait and balance issues. Is there a Loss Of Balance Sensation (LOBS) threshold that is \<10g? The monofilament test protocol should include plantar sites across the foot since differences in anteroposterior and/or mediolateral sensitivity may cause balance issues.
* Compare the rate of injurious falls between a group of Walkasins users and non-users over a six-month period.

Eligibility criteria: Inclusion Criteria:

* Able to understand and provide informed consent for him or herself
* Age 55 and older, male or female
* Able to complete all functional outcome measures without the use of an assistive device
* Clinical diagnosis of peripheral neuropathy prior to participating in the study as documented in the participant's medical record or by physician's note. Individuals with chemo-induced peripheral neuropathy must be at least one-year post-chemotherapy, indicating that their PN has become a chronic condition.
* Self-reported gait and balance problems
* Foot size that allows the Walkasins to function appropriately
* Willing to use the Walkasins device as recommended

Exclusion Criteria:

* Ability to stand on one leg for at least 30 seconds (If the person can stand for at least 30 seconds, he/she is excluded because his/her balance is likely not impaired enough to benefit from Walkasins.)
* Self-reported acute thrombophlebitis, including deep vein thrombosis
* Self-reported severe peripheral vascular disease
* Untreated lymphedema
* Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
* Self-reported, untreated fractures in the foot and ankle
* Other neurological or musculoskeletal conditions that moderately or severely impact walking
* Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
* Weight of more than 300 pounds
* Inability to perceive vibration from Walkasins Haptic Module

Primary outcomes:
measure: Functional Gait Assessment (FGA)
timeFrame: Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52
measure: Patient-Specific Functional Scale (PSFS)
timeFrame: Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52
measure: PROMIS® PROWalk
timeFrame: Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52
Secondary outcomes:
measure: 10-Meter Walk Test
timeFrame: Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52
measure: Four-Stage Balance Test
timeFrame: Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52
measure: Modified Multidirectional Reach Test
timeFrame: Baseline, Week 10, Week 26, Week 36 (Control Group), Week 52
measure: Single Leg Stance Test
timeFrame: Baseline, Week 26
measure: Timed Up and Go (TUG) and Timed Up and Go Cognitive/Dual Task (TUG-COG)
timeFrame: Baseline, Week 10, Week 26, Week 36 (Control Group), Week 52
measure: Activities-specific Balance Confidence Scale 6 (ABC-6)
timeFrame: Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52
measure: EuroQol HRQoL (EQ-5D-5L)
timeFrame: Baseline, Week 10, Week 26, Week 36, and Week 52
measure: PROMIS® Scale v2.0 - Pain Intensity 3a and Neuropathic Foot Pain Rating
timeFrame: Baseline, Week 10, Week 26, Week 36, Week 52
measure: Rapid Assessment of Physical Activity (RAPA) and Telephone Assessment of Physical Activity (TAPA)
timeFrame: Baseline, Week 10, Week 18, Week 26, Week 36, and Week 52
measure: Walkasins Experience Survey
timeFrame: Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52
Other outcomes:
measure: Falls Monitoring
timeFrame: Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52
measure: Monofilament Test
timeFrame: Baseline, Week 26, and Week 52
measure: Vibration Test
timeFrame: Baseline, Week 26, and Week 52
Locations:
city: Boston
country: United States
facility: Marcus Institute for Aging Research, Hebrew SeniorLife
state: Massachusetts
city: St. Paul
country: United States
facility: Fairview Frontiers
state: Minnesota
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: RxFunction Inc.
name: Lars Oddsson, PhD
role: STUDY_DIRECTOR
References:
citation: Hsu CL, Manor B, Iloputaife I, Oddsson LIE, Lipsitz L. Six month lower-leg mechanical tactile sensory stimulation alters functional network connectivity associated with improved gait in older adults with peripheral neuropathy - A pilot study. Front Aging Neurosci. 2022 Nov 3;14:1027242. doi: 10.3389/fnagi.2022.1027242. eCollection 2022.
citation: Koehler-McNicholas SR, Danzl L, Cataldo AY, Oddsson LIE. Neuromodulation to improve gait and balance function using a sensory neuroprosthesis in people who report insensate feet - A randomized control cross-over study. PLoS One. 2019 Apr 30;14(4):e0216212. doi: 10.1371/journal.pone.0216212. eCollection 2019.
citation: Oddsson LIE, Bisson T, Cohen HS, Iloputaife I, Jacobs L, Kung D, Lipsitz LA, Manor B, McCracken P, Rumsey Y, Wrisley DM, Koehler-McNicholas SR. Extended effects of a wearable sensory prosthesis on gait, balance function and falls after 26 weeks of use in persons with peripheral neuropathy and high fall risk-The walk2Wellness trial. Front Aging Neurosci. 2022 Sep 20;14:931048. doi: 10.3389/fnagi.2022.931048. eCollection 2022.
citation: Oddsson LIE, Bisson T, Cohen HS, Jacobs L, Khoshnoodi M, Kung D, Lipsitz LA, Manor B, McCracken P, Rumsey Y, Wrisley DM, Koehler-McNicholas SR. The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial. Front Aging Neurosci. 2020 Nov 9;12:592751. doi: 10.3389/fnagi.2020.592751. eCollection 2020.