N/A
N=69
walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis
Sensory Peripheral Neuropathy · Balance; Distorted · Sensation Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03538756 ↗Enrolled (actual)
69
Serious AEs
14.5%
Results posted
Dec 2022
Primary outcome: Primary: Functional Gait Assessment — 14.8; 14.8; 14.8; 17.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Walkasins (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RxFunction Inc.
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Gait Assessment |
14.8; 14.8; 14.8; 17.0; 18.2; 17.14 | — |
| SECONDARY 10-Meter Walk Test |
0.90; 0.85; 0.88; 0.92; 0.91; 0.95 | — |
| SECONDARY Timed Up and Go Test (TUG) |
13.9; 13.5; 13.7; 13.7; 12.8; 13.2 | — |
| SECONDARY Four-Stage Balance Test |
24.2; 26.5; 25.3; 25.4; 26.6; 26.0 | — |
| SECONDARY Activities-specific Balance Confidence (ABC) Scale |
58.2; 61.2; 59.6; 62.5; 62.3; 63.6 | — |
| SECONDARY Vestibular Activities of Daily Living Scale (VADL) |
3.97; 3.82; 3.89; 3.49; 3.66; 3.78 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
5.19; 4.30; 4.77; 3.97; 4.12; 4.18 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b |
52.6; 50.1; 51.4; 51.7; 51.1; 52.2 | — |
| SECONDARY PROMIS Pain Intensity Form 1a |
3.2; 2.4; 2.8; 2.6; 2.8; 2.7 | — |
| SECONDARY PROMIS Ability to Participate Short Form 8a |
48.8; 50.7; 49.7; 51.1; 50.9; 51.1 | — |
| SECONDARY PROMIS Satisfaction With Participation in Social Roles Short Form 8a |
47.7; 49.9; 48.7; 49.2; 50.1; 50.4 | — |
| SECONDARY Falls |
53; 39 | — |
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.
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.)
Data sourced from ClinicalTrials.gov (NCT03538756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.