ClinicalTrials.Veeva

Menu

Gait Metric Validation of the Cionic Neural Sleeve

C

Cionic

Status

Enrolling

Conditions

Validation Study

Treatments

Device: Neural Sleeve and Zeno walkway

Study type

Observational

Funder types

Industry

Identifiers

NCT06503354
IRB-FY2024-253

Details and patient eligibility

About

The purpose of this study is to determine the validity of the Neural Sleeve gait metrics compared to gait parameters assessed with a Protokinetics Zeno pressure sensitive walkway. The spatiotemporal gait parameters obtained from the Zeno walkway have been rigorously validated and will represent the "gold standard" ground truth measurements in the proposed protocol. Confirming the validity of the Neural Sleeve metrics offers benefit to individuals who utilize the device by providing confidence that calculated gait reports are accurate and can be used to inform usage of the device and associated gait changes over time. Findings of innaccuracy would still offer benefit in the form of knowing that the Neural Sleeve metrics need to be used with caution and/or updated to provide correct outcomes to users.

Full description

The study aims to validate the gait metrics of the Neural Sleeve in healthy adult volunteers. All participants will wear a Neural Sleeve on their dominant leg. The Zeno pressure gait mat will be laid flat on the ground and used for all walking conditions. Overall, participants will perform three, 5 minute walking bouts without electrical stimulation. Two walking conditions will be performed while wearing the Neural Sleeve, however, no electrical stimulation will be utilized. The movement sensors on the Neural Sleeve will collect motion data that permits the comparison of gait metrics from the Sleeve to those measured by the gait mat. During the walking trials participants will be told that they can take a break if needed. Condition order will be randomized and participants will be offered 5 minutes of rest between consecutive trials. Validity of gait metrics of the Neural Sleeve will be compared against the Zeno walkway.

Enrollment

50 estimated patients

Sex

All

Ages

22 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Persons between the ages of 22-64
  • Ability to ambulate at least 30 minutes during a two hour period

Exclusion criteria

  • Lower motor neuron disease or injury (e.g. peripheral neuropathy)
  • Absent sensation in the legs
  • Demand-type cardiac pacemaker or defibrillator
  • Malignant tumor in the legs
  • Existing thrombosis in the legs
  • History of lower limb injury or orthopedic issues leading to impaired walking

Trial design

50 participants in 1 patient group

Participants
Description:
Healthy adults
Treatment:
Device: Neural Sleeve and Zeno walkway

Trial contacts and locations

1

Loading...

Central trial contact

Douglas Wajda, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems