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

Overview

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.

Interventions

• Device Walkasins
  Walkasins® is an external, lower limb sensory prosthesis intended to replace part of the nerve function used for detection and signaling of foot pressure sensation during standing and walking activities. Walkasins consist of two parts for each leg: the Haptic Module and the Receptor Sole. The Haptic Module wraps around the lower leg of the user and contains electronics for reading Receptor Sole pressure signals, a microprocessor, and four vibrating motors that provide gentle tactile sensory cues
• Other Fall Prevention Training
  Participants will watch "6 Steps to Prevent a Fall," a short (2 minute) educational video from the National Council on Aging, which describes simple steps to reduce fall risk. To improve their access to the education provided, participants will also receive three handouts, produced by the Center for Disease Control and Prevention (CDC) STEADI initiative (Stopping Elderly Accidents, Deaths, and Injuries), to review after the study visit. The STEADI Initiative is a coordinated approach for healthc

Primary outcome measures

• Functional Gait Assessment (FGA) [Time frame: Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52]
• Patient-Specific Functional Scale (PSFS) [Time frame: Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52]
• PROMIS® PROWalk [Time frame: Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52]

Secondary outcome measures (10)

• 10-Meter Walk Test [Time frame: Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52]
• Four-Stage Balance Test [Time frame: Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52]
• Modified Multidirectional Reach Test [Time frame: Baseline, Week 10, Week 26, Week 36 (Control Group), Week 52]
• Single Leg Stance Test [Time frame: Baseline, Week 26]
• Timed Up and Go (TUG) and Timed Up and Go Cognitive/Dual Task (TUG-COG) [Time frame: Baseline, Week 10, Week 26, Week 36 (Control Group), Week 52]
• Activities-specific Balance Confidence Scale 6 (ABC-6) [Time frame: Baseline, Week 5, Week 10, Week 18, Week 26, Week 31, Week 36, Week 41, Week 46, and Week 52]
• EuroQol HRQoL (EQ-5D-5L) [Time frame: Baseline, Week 10, Week 26, Week 36, and Week 52]
• PROMIS® Scale v2.0 - Pain Intensity 3a and Neuropathic Foot Pain Rating [Time frame: Baseline, Week 10, Week 26, Week 36, Week 52]
• Rapid Assessment of Physical Activity (RAPA) and Telephone Assessment of Physical Activity (TAPA) [Time frame: Baseline, Week 10, Week 18, Week 26, Week 36, and Week 52]
• Walkasins Experience Survey [Time frame: Baseline, Week 10, Week 26, Week 36 (Control Group), and Week 52]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 6 centers

• OrthoArizona--Mesa Arbor Avenue — Mesa
• Marcus Institute for Aging Research, Hebrew SeniorLife — Boston
• Fairview Frontiers — Saint Paul
• Dent Neurologic Institute — Amherst
• University of Pittsburgh — Pittsburgh
• University of Texas Medical Branch — Galveston

Publications

• 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. PMID 36408098
• 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. PMID 31039180
• 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.20 PMID 36204554
• 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. PMID 33240077

Identifiers

NCT: NCT06959277 · CIP 0010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗