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

Completed · Not applicable

Conditions studied: Sensory Peripheral Neuropathy, Balance; Distorted, Sensation Disorders

In brief

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.

Key facts

Study ID

NCT03538756

Run by

RxFunction Inc.

People needed

69

Starts

2018-10-22

Expected to finish

2021-12-31

Last updated by the study team

2022-12-22

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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
• 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.)

Where it is running

• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• Marcus Institute for Aging Research, Harvard Medical School — Boston, Massachusetts, United States
• Minneapolis VA Health Care System — Minneapolis, Minnesota, United States
• Fairview Health Services — Saint Paul, Minnesota, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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