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



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 90
Updated:12/13/2018
Start Date:October 22, 2018
End Date:June 2021
Contact:Lars Oddsson, PhD
Email:loddsson@rxfunction.com
Phone:612-358-2140

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

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.

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.

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 the walkasins® to function appropriately (women's size 5 through
men's size 12)

- 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®

- Open wounds on the foot or calf as determined by clinician assessing risk

- 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 clinical trial
(Ongoing/current or previous balance PT is not an exclusionary criterion.)
We found this trial at
3
sites
Minneapolis, Minnesota 55417
Principal Investigator: Sara Koehler-McNicholas, PhD
Phone: 612-467-4705
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Helen Cohen, EdD
Phone: 713-798-5233
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Saint Paul, Minnesota 55114
Principal Investigator: Teresa Bisson, DPT
Phone: 612-273-6510
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Saint Paul, MN
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