Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems

RxFunction

Status: Not yet enrolling

Conditions: Balance Control in Elderly; Peripheral Neuropathy With Type 2 Diabetes; Peripheral Neuropathy Due to Chemotherapy; Gait Disorders; Peripheral Neuropathies

Treatments: Other: Fall Prevention Training; Device: Walkasins

Study type: Interventional

Funder types: Industry

Identifiers

NCT06959277

CIP 0010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Walkasins User Group

Experimental group

Description:

Participants randomized to the user group will receive Walkasins, consisting of two parts for each leg: the Haptic Module and the Receptor Sole. They will use the device for one year (52 weeks). In addition, the user group participants will receive the fall prevention information provided to the control group.

Treatment:

Device: Walkasins

Other: Fall Prevention Training

Control Group

Other group

Description:

Participants randomized to the control group will receive fall prevention information during the baseline visit. After six months, they will receive Walkasins for use during the final six months of the trial.

Treatment:

Other: Fall Prevention Training