Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity

Official title

Wearable Sensory Prostheses to Improve Neuromuscular Coordination, Walking Function, and Real-World Physical Activity

Overview

The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN). The main question it aims to answer is whether Walkasins enhances habitual activity patterns in adults with peripheral neuropathy. Participants will do the following as part of the study: * Complete a sensation and balance assessment to determine eligibility for the study. * Answer questions about their medical history, physical function, balance confidence, and sleep. * Perform various balance and walking tasks on three separate occasions. One of the tests involves walking for six minutes without a cane or walker. * Wear an activPAL activity monitor for ten days on three separate occasions and return it to the researcher as directed. * Wear Walkasins for ten weeks as part of their daily routine. Walkasins consists of two parts: 1) an insole that fits inside the shoe and 2) a strap that secures around the ankle.

Detailed description

This will be a prospective within-participant study design conducted over a period of one year. After providing informed consent, all participants will undergo a battery of instrumented mobility assessments (e.g., 6-minute walk test \[6MWT\], Functional Gait Assessment \[FGA\], etc.), questionnaires, and a 10-day habitual physical activity observation period, wearing an electronic event logger to derive the primary outcomes. This initial (baseline) assessment, without the sensory assistance of the Walkasins, will allow participants to serve as their own control. Assessment and observation periods will be repeated at the dispensing of the Walkasins device and after participants have acclimated to daily use, 10 weeks after participants have begun wearing the device.

Interventions

• Device External, lower limb sensory prosthesis
  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

Primary outcome measures

• Activity Score--Metabolic Equivalents (METs) [Time frame: Over a period of ~12 weeks]
• Step Count [Time frame: Over a period of ~12 weeks]
• Total Sedentary Time [Time frame: Over a period of ~12 weeks]
• 6-Minute Walk Test--Phase Coordination Index (PCI) [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]

Secondary outcome measures (11)

• Activities-specific Balance Confidence (ABC) Scale [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]
• International Physical Activity Questionnaire (IPAQ) or IPAQ for Elderly Adults (IPAQ-E) [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]
• PROMIS Scale v2.0 - Pain Intensity 3a [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]
• PROMIS PROWalk [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]
• PROMIS Sleep-Related Impairment (SRI) and Sleep Disturbance [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]
• 10-Meter Walk Test [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]
• 2-Minute Dual-Task Walk (2MDTW) [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]
• Timed Up and Go (TUG) [Time frame: Baseline, Walkasins Initiation,]
• Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]
• Single Leg Stance (SLS) [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]
• Functional Gait Assessment (FGA) [Time frame: Baseline, Walkasins Initiation, Follow-up (Week 10)]

Eligibility criteria

Inclusion criteria

• Be 60 years of age or older
• Have a diagnosis of PN with plantar sensory loss
• Demonstrate balance impairment, defined as a Single-Leg Stance time of <23 seconds
• Be able to walk independently for at least 6 minutes without the use of an assistive device (rest breaks permitted)
• Be willing to use the Walkasins device as recommended
• Be willing to participate in all aspects of physical activity monitoring and study assessments

Exclusion criteria

• Under 60 years old
• Do not have a diagnosis of PN with plantar sensory loss
• 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
• Do not demonstrate balance impairments, defined as a Single-Leg Stance time of <23 seconds

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

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Brooks Rehabilitation Center — Jacksonville

Publications

• 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: NCT07554443 · CIP 0012

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗