Clicking shoe could help stroke survivors walk more easily
NCT ID NCT06234124
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new shoe that makes a clicking sound when you walk, designed to help people with foot drop after a stroke. Foot drop makes it hard to lift the front part of your foot, causing tripping. The shoe gives audio feedback to help you walk more naturally. Fifty adults who had a stroke at least 3 months ago will try the shoe at home for several weeks, and researchers will measure changes in walking speed and balance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Variable Friction Shoe (a shoe that makes a clicking sound when walking)
- What this could lead to
- If it works, this could offer a low-cost, easy-to-use device to improve walking and balance for people with foot drop after stroke.
- What could go wrong
- This is a small early-stage trial with only 50 people, so results may not apply to everyone. The shoe may not help all users, and some may find the clicking annoying or ineffective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. At least 3 months poststroke 2. Age 18 or older 3. Possess a prescribed AFO or be a potential candidate for use of an AFO 4. Can ambulate at least 10m with or without an assistive device such as a cane or walker 5. Medically stable as determined by physician medical clearance 6. No expected change in medications for at least 3 months 7. Adequate stability at the ankle during stance 8. Ability to hear clicking noise made by the VF shoe 9. Physician approval 10. Ability to give informed consent 11. Able to sit unsupported and be able to follow a three-step command 12. No unhealed/unresolved orthopedic injury to either upper or lower extremity and no history of severe back pain 13. English speaking 14. Willing to follow an exercise program with both devices for at least 30 minutes per day, at least 5 days per week for the full length of the program (6 months) Exclusion Criteria: 1. History of falling more than once a week prior to the stroke 2. Gait speed: self-selected velocity (SSV) greater than 1.2 m/s 3. Inability to operate in the devices safely and no caregiver assistance available 4. Morbid obesity (body mass index \>40 kg/m2) 5. Preexisting conditions such as serious cardiac conditions, myocardial infarction, congestive heart failure, demand pacemaker, seizures, excessive dysesthetic pain, and severe lower extremity pathology that would interfere with fit or use of the shoe. 6. Severe deficits in cognition or communication 7. Pregnant women (status determined by self-reporting). 8. Co-morbidity that interferes with the study (e.g. significant arthritis or joint problems, history of back injury, neuromuscular disorders, epilepsy, etc.). 9. Severe Osteoporosis (status determined by self-reporting). 10. Prisoners 11. Not currently receiving botox to the lower extremities.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shirley Ryan AbilityLab
RECRUITINGChicago, Illinois, 60611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Zapping the spine while wearing a robotic ankle: a new way to help kids walk?
- Can a nurse and a neighbor help tame chronic disease?
- Can PET scans reveal hidden heart inflammation after a stroke?
- Two ways to catch a hidden heart rhythm after stroke