walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis

NCT03538756 | Completed Results FDA Device

• 1 other identifier: CIP 0002 & CIP 0003
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 5

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.

Conditions

Sensory Peripheral Neuropathy; Balance; Distorted; Sensation Disorders

Keywords

Balance; Peripheral Neuropathy; Neuropathy

Outcome Measures

Primary Outcomes (1)

• Functional Gait Assessment

  The Functional Gait Assessment (FGA) is a 10-item scale that measures postural stability while individuals perform walking tasks that are scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate impairment, 0 = severe impairment). Scores range from a minimum of 0 to a maximum of 30. Higher scores indicate better postural stability. (Participants scoring 23 or higher on the baseline FGA were not included in this study because their peripheral neuropathy was not yet affecting their gait/balance significantly.)

  Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52

Secondary Outcomes (11)

• 10-Meter Walk Test

  Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52

• Timed Up and Go Test (TUG)

  Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52

• Four-Stage Balance Test

  Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52

• Activities-specific Balance Confidence (ABC) Scale

  Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52

• Vestibular Activities of Daily Living Scale (VADL)

  Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52

Study Arms (3)

Baseline Group A--Walkasins On Then Off

EXPERIMENTAL

Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off. After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits

Device: Walkasins

Baseline Group B--Walkasins Off Then On

EXPERIMENTAL

Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on. After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.

Device: Walkasins

Single Arm Long-Term Follow-up

EXPERIMENTAL

During the baseline visit, participants were randomized to two groups that applied to the first visit only. After the baseline visit, community-dwelling participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52, during which they repeated the functional measures while wearing their Walkasins and responded to the questionnaires. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, device usage, and device functioning. Note: Due to COVID-19 disruptions, some participants were not able to return for all in-person follow-up visits. They completed the patient-reported outcome measures via telephone visits.

Device: Walkasins

Interventions

Walkasins DEVICE

Walkasins® consist of two parts for each leg: the Haptic Module (leg unit) and the Receptor Sole (foot pad). 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 to the front, back, medial, and lateral surfaces of the user's leg. These cues reflect real-time foot pressure information at a location above the ankle where skin sensation is still present.

Baseline Group A--Walkasins On Then Off; Baseline Group B--Walkasins Off Then On; Single Arm Long-Term Follow-up

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RxFunction Inc.: lead

Study Sites (5)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Marcus Institute for Aging Research, Harvard Medical School

Boston, Massachusetts, 02131, United States

Location

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

Fairview Health Services

Saint Paul, Minnesota, 55114, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 36204554 DERIVED

• 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.

  PMID: 33240077 DERIVED

Related Links

• Sponsor Website

MeSH Terms

Conditions

Sensation Disorders; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases

Limitations and Caveats

The main limitations of this trial were the following: (1) It was not blinded, and it lacked a control group and a placebo treatment. (2) We enrolled a greater percentage of males than females. (3) Lockdowns at the study sites due to COVID-19 caused significant disruptions to data collection for the functional measures. Some participants also indicated that COVID-19 impacted their daily activities, which, in turn, affected the amount of time they used the device.

Results Point of Contact

• Title: Lars Oddsson, PhD
• Organization: RxFunction, Inc.

loddsson@rxfunction.com

612-358-2140

Study Officials

• Lars Oddsson, PhD

  RxFunction Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants were randomized only during the baseline visit.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 29, 2018
• Study Start: October 22, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)