New pedaling device aims to retrain Stroke-Damaged legs
NCT ID NCT06329765
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This early study tests a motor-assisted pedaling device called CUped to help stroke survivors recover leg movement and improve walking. The device forces use of the affected leg and prevents bad habits that slow recovery. Only 12 people will take part to check if it is safe, tolerable, and shows any sign of helping.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CUped motor-assisted pedaling device
- What this could lead to
- If it works, this could point toward a new therapy that helps stroke survivors walk better by retraining their affected leg.
- What could go wrong
- This is a very early, small study with only 12 people. It is designed to test safety and basic effects, not to prove it works. Many early-stage ideas do not lead to a treatment.
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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13 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Dec 2025
- 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 to 100 years
- 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: * Single, unilateral stroke in adulthood. * Cortical, subcortical stroke. Individuals with cortical lesions affecting sensory and motor structures in the gray matter of the brain will be included. Individuals subcortical white matter lesions affecting the internal capsule and corona radiata will be included. * Ischemic, hemorrhagic stroke. Individuals with ischemic and hemorrhagic strokes will be admitted. Because ischemic stroke is more common than hemorrhagic, the investigators expect a smaller proportion of volunteers from the latter group. * Chronic stroke. Individuals with chronic stroke, defined as \>6 months post infarct, will be included. * Able to walk 10 m. Stroke survivors capable of walking 10 m overground will be admitted. Canes, walkers, braces, and other devices will be allowed. This study examines the effect of CUped on gait kinematics and kinetics; therefore, the ability to walk is imperative. * Unilateral motor impairment consistent with hemiparesis. * Learned non-use of the paretic limb. Non-use will be verified by comparing paretic limb work (W) during unilateral and bilateral coupled pedaling. Participants with non-use will be identified as those who produce significantly \<50% of the total W of bilateral coupled pedaling with their paretic limb but are capable of unilateral pedaling with the paretic limb at a workload equivalent to 50% of the total W of bilateral coupled pedaling. (Significance will be determined using a 1-sample t-test or corresponding non-parametric test in the case of non-normality). * No contraindications for exercise. Contraindications to exercise include but may not be limited to recent electrocardiogram changes or recent myocardial infarction, uncontrolled arrhythmia, unstable angina, third degree heart block, acute progressive heart failure, uncontrolled hypertension, and orthopedic conditions (e.g., severe muscle contracture, arthritis, acute limb injury) that may interfere with pedaling. * Age ≥18. All participants must be at least 18 years of age. The investigators are studying adult not childhood stroke. Recovery mechanisms are different between adult and childhood stroke survivors. * Able to commit to 27 visits to the lab (pre-, mid-, post-test, plus 24 training sessions). Exclusion Criteria: * More than 1 stroke. Individuals with more than one clinically apparent stroke, as evidenced by residual impairments and/or medical imaging, will be excluded. Individuals with history of transient ischemic attack (TIA) resulting in no residual impairments or brain damage will NOT be excluded. * Stroke in the cerebellum or basal ganglia. Individuals with stroke affecting primarily the cerebellum or basal ganglia will be excluded. The cerebellum has an important role in motor learning. Given that CUped depends on motor learning, people with cerebellar strokes may not benefit. Basal ganglia strokes can cause tremor, which is not the target of CUped. However, individuals with predominantly internal capsule lesions that also affect the basal ganglia will be included. * Dementia or other cognitive impairment that interferes with learning and/or the ability to consent. * Communication impairments, such as receptive aphasia, that prevent safe participation. Expressive aphasia is not an exclusion criterion. Participants will be included as long as they have a method to communicate willingness to participate, discomfort, and/or the desire to start or stop a study activity. * Orthopedic impairments that interfere with pedaling. * Cardiovascular contraindications to exercise. * Inability to walk 10 m overground. Participants will be excluded in they are not able to walk 10 m overground our cannot do so safely. * Neurological disorder other than stroke. Individuals with history or signs of any neurologic disease or injury other than stroke will be excluded. Such conditions may include head trauma, cerebral palsy, epilepsy, brain tumor, diabetic neuropathy, dementia, multiple sclerosis, Parkinson's disease, or Alzheimer's disease. * Other conditions that interfere with safe participation or data integrity. Participants will be excluded if, at any point in the recruitment or enrollment process, the investigators become aware of a condition that increases risk beyond that indicated in our IRB protocols. Exclusion will also occur if the investigators become aware of a condition that introduces an experimental variable that could confound the results of the study. * Failure to meet any inclusion criteria listed above.
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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.
Contacts and locations
Locations
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Marquette University
Milwaukee, Wisconsin, 53201, United States
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Other studies related to the condition(s) this trial covers.
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