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

• ClinicalTrials.gov Identifier: NCT03538756
• Recruitment Status: Active, not recruiting
• First Posted: May 29, 2018
• Last Update Posted: May 2, 2022
• Sponsor: RxFunction Inc.
• Information provided by (Responsible Party): RxFunction Inc.

Tracking Information

• First Submitted Date: May 15, 2018
• First Posted Date: May 29, 2018
• Last Update Posted Date: May 2, 2022
• Actual Study Start Date: October 22, 2018
• Actual Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 24, 2018)

Improvement in Functional Gait Assessment [ Time Frame: 10 Weeks ]

Subjects will show a sustained improvement of their Functional Gait Assessment (FGA) of at least 4 compared to their initial assessment.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 25, 2022)

• 10-Meter Walk Test [ Time Frame: 10 Weeks ]
  The investigators expect to see trends of increasing gait speed as assessed by the 10-meter Walk Test. (The middle 6 meters are timed.)
• Timed Up and Go Test (TUG) [ Time Frame: 10 Weeks ]
  The investigators expect to see improvement in subjects' performance in the Timed Up and Go Test, which is part of the CDC-recommended STEADI test protocol for balance function. The tester will record the time taken from the command "Go" until the subject sits down again.
• Four-Stage Balance Test [ Time Frame: 10 Weeks ]
  The 4-Stage Balance Test is part of the Centers for Disease Control-recommended test protocol for balance function. It includes four gradually more challenging postures the subject is exposed to.
• Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 10 Weeks ]
  Subjects will complete the PHQ-9 to assess their emotional well-being.
• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b [ Time Frame: 10 Weeks ]
  Subjects will complete the Pain Interference Short Form 6b to determine how much their pain interferes will their activities.
• PROMIS Pain Intensity Form 1a [ Time Frame: 10 Weeks ]
  The PROMIS Pain Intensity instrument assesses how much a person hurts.
• PROMIS Ability to Participate Short Form 8a [ Time Frame: 10 Weeks ]
  The PROMIS Ability to Participate in Social Roles and Activities assesses the perceived ability to perform one's usual social roles and activities.
• PROMIS Satisfaction with Participation in Social Roles Short Form 8a [ Time Frame: 10 Weeks ]
  The PROMIS Satisfaction with Social Roles and Activities items assess satisfaction with performing one's usual social roles and activities (e.g., "I am satisfied with my ability to participate in family activities").
• Falls [ Time Frame: 10 Weeks ]
  Subjects will be asked about the number of times they have fallen in the past 6 and 12 months and whether they incurred an injury from falling. These data will be compared to falls during their participation in the trial as tracked with a calendar and reported as adverse events. Falls data will be monitored as overall number of fallers pre-and post-study participation as well as the number of falls/1000 patient days.

Original Secondary Outcome Measures (submitted: May 24, 2018)

• 10-Meter Walk Test [ Time Frame: 10 Weeks ]
  We expect to see trends of increasing gait speed as assessed by the 10-meter Walk Test, which measures how fast a person can walk 10 meters. (Only the middle six meters are timed.)
• Timed Up and Go Test (TUG) [ Time Frame: 10 Weeks ]
  We expect to see improvement in subjects' performance in the Timed Up and Go Test, which is part of the CDC-recommended STEADI test protocol for balance function. The tester will record the time taken from the command "Go" until the subject sits down again.
• Four-Stage Balance Test [ Time Frame: 10 Weeks ]
  The 4-Stage Balance Test is part of the CDC-recommended test protocol for balance function. It includes four gradually more challenging postures the subject is exposed to.
• PHQ-9 [ Time Frame: 10 Weeks ]
  Subjects will complete the PHQ-9 to assess their emotional well-being.
• PROMIS Pain Interference Short Form 6b [ Time Frame: 10 Weeks ]
  Subjects will complete the Pain Interference Short Form 6b to determine how much their pain interferes will their activities.
• PROMIS Pain Intensity Form 1a [ Time Frame: 10 Weeks ]
  The PROMIS Pain Intensity instrument assesses how much a person hurts.
• PROMIS Ability to Participate Short Form 8a [ Time Frame: 10 Weeks ]
  The PROMIS Ability to Participate in Social Roles and Activities assesses the perceived ability to perform one's usual social roles and activities.
• PROMIS Satisfaction with Participation in Social Roles Short Form 8a [ Time Frame: 10 Weeks ]
  The PROMIS Satisfaction with Social Roles and Activities items assess satisfaction with performing one's usual social roles and activities (e.g., "I am satisfied with my ability to participate in family activities").

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 objective of the current study is to show a long-term (10 weeks) sustained improvement in FGA score >4 following Walkasins use as compared to initial baseline assessment and to examine a potential relationship between initial baseline assessment data and long-term outcome. The finding of a short-term FGA change >4 during Walkasins use justifies a pre-post study design to investigate the long-term effects 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 replication will occur during the baseline visit.) This study will help to further refine the prescription criteria for Walkasins and determine whether the presence of a short-term response is indicative of long-term improvements or not.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Sensory Peripheral Neuropathy
• Balance; Distorted
• Sensation Disorders

Intervention

Device: Walkasins

Walkasins® consist of two parts for each leg: the leg unit and the foot pad. The leg unit wraps around the lower leg of the user and contains electronics for reading foot pad 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.

Study Arms

• Experimental: Group A--Walkasins On Then Off

  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.

  Intervention: Device: Walkasins
• Experimental: Group B--Walkasins Off Then On

  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.

  Intervention: Device: Walkasins

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 31, 2021): 84
• Original Estimated Enrollment (submitted: May 24, 2018): 100
• Estimated Study Completion Date: June 2022
• Actual Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

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.)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03538756
• Other Study ID Numbers: CIP-0002 & CIP-0003
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: RxFunction Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: RxFunction Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Lars Oddsson, PhD; RxFunction Inc.

• PRS Account: RxFunction Inc.
• Verification Date: April 2022