Validation StudyNCT06503354
Gait Metric Validation of the Cionic Neural Sleeve
An observational study of Validation Study, run by Cionic, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Validation Study
- What is being tested?
- Neural Sleeve and Zeno walkway
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 11 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults
Who may be able to join
- Persons between the ages of 22-64
- Ability to ambulate at least 30 minutes during a two-hour period
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Cleveland State University, Department of Health Sciences and Human Performance
Cleveland, Ohio, 44115-2214
About this study
Official title: Validation of Gait Metrics From Cionic Neural Sleeve
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 inaccuracy 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.
Read the detailed 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 four walking conditions. Participants will perform two 5-minute walking bouts at each of the four speed conditions while wearing the Cionic Neural Sleeve without electrical stimulation. The movement sensors on the Neural Sleeve will collect motion data that permits the comparison of gait metrics from the Neural 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.
- Conditions
- Validation Study
- Being tested
- Neural Sleeve and Zeno walkway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Sleeve and Zeno walkwayDevice
A standard manual stopwatch will be used to record time. The Zeno pressure gait mat will be laid flat on the ground and used for all walking conditions/speed. Participants will perform two 5-minute walking bouts for each of the four walking conditions while wearing the Neural Sleeve without electrical stimulation. For normal walking speed, participants walked at their normal, comfortable pace for 5 minutes. For fast walking speed, participants walked to cover as much distance as possible for 5 minutes. For intermittent-slow speed, participants were instructed to walk as if browsing in a museum. For slow speed, participants walked at a slow, steady pace. The order of conditions was randomized. They will walk back and forth along a 12-meter course with the gait mat in the center of the course. Participants will not receive any intervention or treatment. Simultaneously, the Zeno walkway will be operated according to manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Healthy adults Receives: Device: Neural Sleeve and Zeno walkway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Time one takes to walk a specified distance (expressed as a ratio between distance and time, in centimeters per second)
Measured: A walking session of up to 5 minutes
Stride length
Distance (centimeters) covered when one takes two steps, one with each foot, measured from ipsilateral heel contact to the next ipsilateral heel contact (right-to-right or left-to-left heel) (centimeters)
Measured: A walking session of up to 5 minutes
Cadence
Number of steps per minute (steps per minute)
Measured: A walking session of up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start8 Jul 2024
- Primary completion1 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cionic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503354
- Sponsor's protocol ID
- IRB-FY2024-253
- Status last verified
- Dec 2025
- First submitted
- 2 Jul 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Gait Metrics From Cionic Neural Sleeve
- ClinicalTrials.gov ID
- NCT06503354
- Acronym / sponsor ID
- IRB-FY2024-253
- Conditions
- Validation Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Cionic, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 inaccuracy 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.
Detailed 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 four walking conditions. Participants will perform two 5-minute walking bouts at each of the four speed conditions while wearing the Cionic Neural Sleeve without electrical stimulation. The movement sensors on the Neural Sleeve will collect motion data that permits the comparison of gait metrics from the Neural 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: Neural Sleeve and Zeno walkwayHealthy adults |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults
Key inclusion criteria (2 listed)
- Persons between the ages of 22-64
- Ability to ambulate at least 30 minutes during a two-hour period
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural Sleeve and Zeno walkwayA standard manual stopwatch will be used to record time. The Zeno pressure gait mat will be laid flat on the ground and used for all walking conditions/speed. Participants will perform two 5-minute walking bouts for each of the four walking conditions while wearing the Neural Sleeve without electrical stimulation. For normal walking speed, participants walked at their normal, comfortable pace for 5 minutes. For fast walking speed, participants walked to cover as much distance as possible for 5 minutes. For intermittent-slow speed, participants were instructed to walk as if browsing in a museum. For slow speed, participants walked at a slow, steady pace. The order of conditions was randomized. They will walk back and forth along a 12-meter course with the gait mat in the center of the course. Participants will not receive any intervention or treatment. Simultaneously, the Zeno walkway will be operated according to manufacturer's instructions. | Device | Participants |
Primary outcome
Gait speed
Time frame: A walking session of up to 5 minutes
Time one takes to walk a specified distance (expressed as a ratio between distance and time, in centimeters per second)
Stride length
Time frame: A walking session of up to 5 minutes
Distance (centimeters) covered when one takes two steps, one with each foot, measured from ipsilateral heel contact to the next ipsilateral heel contact (right-to-right or left-to-left heel) (centimeters)
Cadence
Time frame: A walking session of up to 5 minutes
Number of steps per minute (steps per minute)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation Study, run by Cionic, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: A walking session of up to 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.