Clinical trial NCT03538756: walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis
Official title: walk2Wellness: Long-term Use Effects of Walkasins® Wearable Sensory Prosthesis on Gait Function, Balance-Confidence, and Social Participation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensory Peripheral Neuropathy
Balance; Distorted
Sensation Disorders
Keywords: Balance
Peripheral Neuropathy
Neuropathy
Lead sponsor: RxFunction Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants were randomized only during the baseline visit.
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the long-term effects of Walkasins® use on clinical and subject-reported outcomes of balance and gait function, quality of life, physical activity/participation, pain, and medication use in persons with peripheral neuropathy who experience balance problems.

Detailed description: The main objectives of this single-arm study are to show a long-term (10 weeks), sustained improvement in Functional Gait Assessment (FGA) score \>4 following Walkasins use as compared to participants' initial baseline assessments and to examine a potential relationship between initial baseline assessment data and long-term outcomes. The previous finding of a short-term FGA change \>4 during Walkasins use (NCT02115633) justifies a pre-post study design to investigate the long-term effects of Walkasins use. Although the primary timeframe for the primary endpoint is 10 weeks, participants will return for follow-up visits at 26 weeks and 52 weeks of Walkasins use.

The investigators also intend to extend their observations of the short-term effects of Walkasins by replicating the randomized cross-over design of a previous short-term study. (The randomized cross-over replication will occur only during the baseline visit. The long-term study consists of a single arm.) This study may help to further refine the prescription criteria for Walkasins and determine whether or not the presence of a short-term response is indicative of long-term improvements.

A subset of 10 participants at the Harvard Medical School site will be enrolled in a pilot study to investigate possible structural and functional changes in cortical areas of the brain related to somatosensory connectivity using magnetic resonance imaging (MRI). Structural as well as functional MRI scans will be acquired at baseline and after 26 weeks of daily Walkasins use. An exploratory analysis of MRI data will be performed and related to functional clinical outcomes associated with Walkasins use over the same time period.

Eligibility criteria: Inclusion Criteria:

* Age: 18-90 years, male or female
* Formal diagnosis of sensory peripheral neuropathy prior to participating in the study
* Self-reported balance problems
* Ability for transfers or ambulation on level surfaces at fixed cadence as assessed by the physical therapist during the FGA
* FGA \<23, the cut-off score for high fall-risk
* Ability to understand and provide informed consent
* Foot size that allows Walkasins® to function appropriately
* Must be able to complete all functional outcome measures without the use of an assistive device

Exclusion Criteria:

* Inability to perceive vibration from Walkasins leg unit
* Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
* Acute thrombophlebitis including deep vein thrombosis
* Untreated lymphedema
* Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
* Untreated fractures in the foot and ankle
* Severe peripheral vascular disease
* Musculoskeletal or other neurological conditions that prohibit use of Walkasins as determined by clinician
* Weighs more than 300 pounds
* Plans to begin balance physical therapy (PT) during the first ten weeks of the clinical trial (Ongoing or previous balance PT is not an exclusionary criterion.)

Primary outcomes:
measure: Functional Gait Assessment
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
Secondary outcomes:
measure: 10-Meter Walk Test
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
measure: Timed Up and Go Test (TUG)
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
measure: Four-Stage Balance Test
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
measure: Activities-specific Balance Confidence (ABC) Scale
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
measure: Vestibular Activities of Daily Living Scale (VADL)
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
measure: PROMIS Pain Intensity Form 1a
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
measure: PROMIS Ability to Participate Short Form 8a
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
measure: PROMIS Satisfaction With Participation in Social Roles Short Form 8a
timeFrame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
measure: Falls
timeFrame: Baseline and 26 Weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Boston
country: United States
facility: Marcus Institute for Aging Research, Harvard Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
city: Saint Paul
country: United States
facility: Fairview Health Services
state: Minnesota
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: RxFunction Inc.
name: Lars Oddsson, PhD
role: STUDY_DIRECTOR
References:
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.