Foot DropNCT05346640

Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation

A study testing Cionic Neural Sleeve in people with Foot Drop, run by Cionic, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to investigate the effects of personalized, adaptive, current-steering functional electrical stimulation (FES) of the lower leg to improve gait in people with foot drop. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Foot Drop
What is being tested?: Cionic Neural Sleeve
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: 8 Jun 2021to 25 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged 18-70
Lower extremity impairment that makes walking difficult or uncomfortable
Capable of sitting, standing, and walking independently or with assistance
Able to walk at least 50 feet independently or with assistance
Able to understand and follow basic instructions in English

Who cannot join

Have non-reversible damage to the peripheral nervous system
Have underlying pre-existing conditions like thrombosis/hemorrhage, severe epilepsy or other seizure disorder, severe atrophy or history of implanted electrical devices
Have cognitive impairment that would prevent you from fully understanding the study and ability to provide informed consent
Have lower motor neuron disease or injury that may impair response to stimulation
Are pregnant
Are under the age of 18 years old
Have skin conditions of the affected lower limb, including cuts, burns or lesions

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Cleveland State University
Cleveland, Ohio, 44115
Cionic, Inc.
San Francisco, California, 94133

Other trials in United States

About this study

Read the detailed description

Adaptive, current-steering FES enables precise control over dorsiflexor and evertor muscles, allowing for personalized treatment to correct key foot drop characteristics including dorsiflexion at heel strike and ankle inversion during swing phase. All participants will receive adaptive FES of the dorsiflexors and evertors during back-to-back walking sets. Participants completed up to three walking sets of unstimulated walking (pre-test) followed by lower-leg stimulated walking (post-test). The primary outcome measures include ankle dorsiflexion at heel strike and mean ankle inversion during swing phase. Secondary outcome measures include foot angle at heel strike and single-side heel strike to toe strike time (heel-toe time).

Conditions: Foot Drop
Being tested: Cionic Neural Sleeve
Medical subject headings: Peroneal Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cionic Neural SleeveDevice
Adaptive, functional electrical stimulation

Study groups in NCT05346640
Study group	Role	What they receive
Functional electrical stimulation in individuals with foot drop	Experimental	Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction Receives: Device: Cionic Neural Sleeve

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Dorsiflexion at Heel Strike
Dorsiflexion measured via inertial measurement unit (IMU) sensors placed on the foot and lower leg, measured in degrees. Heel strike is determined from pressure sensors in the shoe.
Measured: 60 minutes
Mean Ankle Inversion During Swing Phase
Ankle inversion measured via IMU sensors placed on the foot and lower leg, measured in degrees. Swing phase is determined from pressure sensors in the shoe
Measured: 60 minutes

Secondary outcomes (2)

Mean Foot Angle at Heel Strike
Foot angle measured via IMU sensors placed on the foot and lower leg, measured in degrees. Heel strike is determined from pressure sensors in the shoe.
Measured: 60 minutes
Mean Heel-Toe Time as a Percent of Gait Cycle
Time of heel-toe, or single-side heel strike to toe strike measured by percent of gait, where 0% represents heel strike and 100% is the next heel strike. Heel strike assessed by pressure sensors placed in the shoe.
Measured: 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202125 Feb 2022

First posted26 Apr 2022
Study start8 Jun 2021
Primary completion25 Feb 2022
Study completion25 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Foot DropStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: A one-group, pre-test post-test study.
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05346640
Sponsor's protocol ID: CIONIC-001
Status last verified: Aug 2023
First submitted: 11 Apr 2022
Last updated: 12 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Muscle MRI Fat Fraction Before Surgery to Predict Strength Recovery After Foot-Drop Surgery in Charcot-Marie-Tooth Disease
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Recruiting
Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop
Falls, Foot Drop
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ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
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Recruiting
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All Foot Drop trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
ClinicalTrials.gov ID: NCT05346640
Acronym / sponsor ID: CIONIC-001
Conditions: Foot Drop
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Cionic, Inc.Industry (pharma, biotech, devices)
Study start: 8 Jun 2021 (actual)
Primary completion: 25 Feb 2022 (actual)
Study completion: 25 Feb 2022 (actual)
First posted: 26 Apr 2022 (actual)
Results: Posted 12 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A one-group, pre-test post-test study.

Arm	Type	Receives
Functional electrical stimulation in individuals with foot drop	Experimental	Device: Cionic Neural SleeveComparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adults aged 18-70
Lower extremity impairment that makes walking difficult or uncomfortable
Capable of sitting, standing, and walking independently or with assistance
Able to walk at least 50 feet independently or with assistance
Able to understand and follow basic instructions in English

Key exclusion criteria (7 listed)

Have non-reversible damage to the peripheral nervous system
Have underlying pre-existing conditions like thrombosis/hemorrhage, severe epilepsy or other seizure disorder, severe atrophy or history of implanted electrical devices
Have cognitive impairment that would prevent you from fully understanding the study and ability to provide informed consent
Have lower motor neuron disease or injury that may impair response to stimulation
Are pregnant

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
Cionic Neural SleeveAdaptive, functional electrical stimulation	Device	Functional electrical stimulation in individuals with foot drop

Primary outcome

Mean Dorsiflexion at Heel Strike
Time frame: 60 minutes
Dorsiflexion measured via inertial measurement unit (IMU) sensors placed on the foot and lower leg, measured in degrees. Heel strike is determined from pressure sensors in the shoe.
Mean Ankle Inversion During Swing Phase
Time frame: 60 minutes
Ankle inversion measured via IMU sensors placed on the foot and lower leg, measured in degrees. Swing phase is determined from pressure sensors in the shoe

2 secondary outcomes

Mean Foot Angle at Heel Strike
Time frame: 60 minutes
Mean Heel-Toe Time as a Percent of Gait Cycle
Time frame: 60 minutes

Results and safety

Results posted to the registry on 12 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Functional Electrical Stimulation in Individuals With Foot Drop	60	32

Primary outcome: Mean Dorsiflexion at Heel Strike

Time frame: 60 minutes. Mean (95% Confidence Interval). Unit: degrees

Measure	Functional Electrical Stimulation in Individuals With Foot Drop n = 32
Value	5.2 (3.5 to 6.8)

Primary outcome: Mean Ankle Inversion During Swing Phase

Time frame: 60 minutes. Mean (95% Confidence Interval). Unit: degrees

Measure	Functional Electrical Stimulation in Individuals With Foot Drop n = 32
Value	-3.6 (-5.3 to -1.8)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Functional Electrical Stimulation in Individuals With Foot Drop	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Limitations and caveats (from the sponsor): This study did not include the collection of certain traditional gait analysis metrics including spatial measures like gait speed and stride length as we relied solely on the on-body device for all data collection and metric extraction. Additionally, we were not able to compare functional electrical stimulation treatment impacts relative to standard of care, i.e. ankle-foot orthosis, in a randomized control trial (RCT). An RCT remains a future research study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Foot Drop

Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Not yet recruitingObservational study
Muscle MRI Fat Fraction Before Surgery to Predict Strength Recovery After Foot-Drop Surgery in Charcot-Marie-Tooth Disease
Foot Drop, Charcot-Marie-Tooth Disease Type 1A
Recruiting
Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop
Falls, Foot Drop
Recruiting
ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
Cerebrovascular Stroke, Foot Drop
Recruiting
Characterization and Clinical Trial of a Variable Friction Shoe
Stroke

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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cionic Neural Sleeve in people with Foot Drop, run by Cionic, Inc. at 2 sites 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 5 inclusion and 7 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Dorsiflexion at Heel Strike (time frame: 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05346640.

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 12 Mar 2024.