walk2Wellness: Long-term Use Effects of Walkasins® Wearable Sensory Prosthesis on Gait Function, Balance-Confidence, and Social Participation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RxFunction Inc.
- Enrollment
- 69
- Locations
- 5
- Primary Endpoint
- Functional Gait Assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.)
Arms & Interventions
Baseline 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: Walkasins (Device)
Baseline 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: Walkasins (Device)
Single Arm Long-Term Follow-up
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.
Intervention: Walkasins (Device)
Outcomes
Primary Outcomes
Functional Gait Assessment
Time Frame: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
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.)
Secondary Outcomes
- Patient Health Questionnaire-9 (PHQ-9)(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)
- PROMIS Pain Intensity Form 1a(Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52)
- PROMIS Ability to Participate Short Form 8a(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)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b(Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52)
- 10-Meter Walk Test(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)
- PROMIS Satisfaction With Participation in Social Roles Short Form 8a(Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52)
- Falls(Baseline and 26 Weeks)