A Wearable "Balance Booster" - Stepping Closer to the Market

Status Completed

Clinical Trial Summary

The overall goal of this project is to continue development and commercialization of a Wearable Sensory Prosthesis termed Walkasins. The device measures foot pressure through a thin sole insert, developed under National Institute on Aging (NIA) Small Business Innovation Research (SBIR) Phase I funding, and displays pressure information through a vibrotactile feedback array, placed around the lower leg, to help improve balance function. The device can replace lost foot pressure sensation in individuals with peripheral neuropathy who have balance problems.

Clinical Trial Description

Our specific aims are to:

1. Revise and finalize design of Walkasins® based on accomplishments, user input, as well as reviewer criticism from our Phase 1 grant and manufacture 200 units of the device for clinical testing.

Milestone 1: 200 units manufactured and ready for clinical testing under Aim 2. This goal is accomplished.

2. Investigate effects of using Walkasins on clinical outcomes related to gait, balance function and associated fall risk in a population of patients with sensory peripheral neuropathy and balance problems.

Hypotheses 1A-B: Patients who are trained to use Walkasins programmed to display relevant balance cues will attain higher gait speed and Functional Gait Assessment when compared to a matched cohort not using Walkasins.

Milestone 2: Data collection to assess clinical utility and safety of the Walkasins on patients briefly trained to use the device has been completed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02115633
Study type	Interventional
Source	RxFunction Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 2016
Completion date	July 28, 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05152368` - Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy	Phase 1
Completed	`NCT05647083` - The Effect of Massage on Diabetic Parameters	N/A
Completed	`NCT02549534` - Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer	N/A
Active, not recruiting	`NCT02701075` - MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain	N/A
Completed	`NCT01196442` - Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer	N/A
Completed	`NCT00763087` - Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet	N/A
Completed	`NCT00079807` - Painful HIV Neuropathy and Alpha-Lipoic Acid	Phase 1/Phase 2
Completed	`NCT03292328` - Yoga for Symptoms of Nerve Damage Caused by Chemotherapy	N/A
Active, not recruiting	`NCT05379140` - Use Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With HIV	N/A
Recruiting	`NCT05673746` - Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer	N/A
Completed	`NCT05189535` - "Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"	Phase 2/Phase 3
Recruiting	`NCT06219590` - Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy	N/A
Enrolling by invitation	`NCT05595109` - Role of Silymarin in Chemotherapy Toxicity and Cognition Improvement in Breast Cancer Patients	Phase 2/Phase 3
Completed	`NCT05916118` - Exercise and Oxaliplatin-induced Peripheral Neuropathy	N/A
Withdrawn	`NCT03881748` - Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy	N/A
Not yet recruiting	`NCT03112057` - Visualize Nociceptor Changes in Neuropathic Human	N/A
Completed	`NCT02936843` - Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy	Phase 2/Phase 3
Terminated	`NCT01458015` - Tapentadol Versus Oxycodon - a Mechanism-based Treatment Approach in Neuropathic Pain	Phase 4
Completed	`NCT01006408` - Treatment Trial Using Low Level Laser Therapy (LLLT) for Treatment of Chemotherapy Induced Peripheral Neuropathy	N/A
Completed	`NCT00471445` - Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients	Phase 3