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

Sponsor

RxFunction Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03538756

Collaborator

(none)

Enrollment

Locations

Arms

38.3

Actual Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sensory Peripheral Neuropathy Balance; Distorted Sensation Disorders	Device: Walkasins	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

walk2Wellness: Long-term Use Effects of Walkasins® Wearable Sensory Prosthesis on Gait Function, Balance-Confidence, and Social Participation

Actual Study Start Date :

Oct 22, 2018

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	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.

Arm

Intervention/Treatment

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.

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.

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.

Device: Walkasins

Outcome Measures

Primary Outcome Measures

Improvement in Functional Gait Assessment [10 Weeks]
Subjects will show a sustained improvement of their Functional Gait Assessment (FGA) of at least 4 compared to their initial assessment.

Secondary Outcome Measures

10-Meter Walk Test [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) [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 [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) [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 [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 [10 Weeks]
The PROMIS Pain Intensity instrument assesses how much a person hurts.
PROMIS Ability to Participate Short Form 8a [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins School of Medicine	Baltimore	Maryland	United States	21287
2	Marcus Institute for Aging Research, Harvard Medical School	Boston	Massachusetts	United States	02131
3	Minneapolis VA Health Care System	Minneapolis	Minnesota	United States	55417
4	Fairview Health Services	Saint Paul	Minnesota	United States	55114
5	Baylor College of Medicine	Houston	Texas	United States	77030