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CUped for Motor Recovery After Stroke

This study is testing a new exercise called CUped (pronounced cupid) for people who have had a stroke and experience weakness on one side of their body (hemiplegia). CUped is a special pedaling device that helps you use your weaker leg to improve walking. The study wants to see if CUped is safe and acceptable, how well it works, and what amount of exercise is most helpful. We are looking for adults aged 18 to 100 who have had a single stroke affecting their brain. The study will measure how much you use your weaker leg when walking and pedaling, and how well your legs work together.

Study design
This is an interventional study with 12 participants. The phase of the study is not specified.
What's involved
You will exercise with the CUped device and do 50 meters of gait (walking) training. The training period will last 6-8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your paretic (weaker) limb use in walking and interlimb coordination will be measured at pretest (up to 1 month before), midpoint (week 3), and posttest (within 1 week after training). Paretic limb use in pedaling will be measured daily during training.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06329765

CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation

Completed
NAAges 18+InterventionalTreatment
Marquette University
~13 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Exercise with CUped - a motor-assisted, split crank pedaling device and undergo 50 m of gait training.

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Paretic limb use in walking
Measured over Pretest (1 day to 1 month before the intervention begins), Posttest (typically within 1 week of completing the intervention) and Midpoint of training (week 3)
+6 more outcomes measured

Conditions

Stroke
Hemiplegia

Explore related trials

HemiplegiaStroke

Where it's being run

1 sites across 1 states
Wisconsin1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Paretic limb use in walkingPretest (1 day to 1 month before the intervention begins), Posttest (typically within 1 week of completing the intervention) and Midpoint of training (week 3)

    Propulsive impulse generated by the paretic limb during overground walking measured from biomechanical gait analysis.

  • Paretic limb use in pedalingEach training day, up to 24 times, through study completion which takes 6-8 weeks.

    Mechanical work generated by the paretic limb during conventional pedaling measured from force-sensitive pedals.

  • Interlimb coordination in walkingPretest (1 day to 1 month before the intervention begins), Posttest (typically within 1 week of completing the intervention) and Midpoint of training (week 3)

    Interlimb phasing of paretic and non-paretic limb during overground walking measured from biomechanical gait analysis.

  • Interlimb coordination in pedalingEach training day, up to 24 times, through study completion which takes 6-8 weeks.

    Relative phasing of paretic and non-paretic limb during split-crank (i.e., bilateral uncoupled) pedaling calculated from position encoders coupled to right and left pedal.

  • Motorized intervention during pedaling split-crank (i.e., bilateral uncoupled) pedalingEach training day, up to 24 times, through study completion which takes 6-8 weeks.

    Magnitude of assistance and resistance applied to the moving limbs during split-crank (i.e., bilateral uncoupled) pedaling measured as electrical current to the motors converted to units of torque.

  • AbsencesEach day of training. There are 24 training sessions delivered over 6 weeks.

    Count the number times each participant misses a scheduled training session. Record the reason for the absence.

  • Adverse eventsEach day of training. There are 24 training sessions delivered over 6 weeks.

    Count the number of adverse events, defined as any undesirable experience associated with CUped. Classify as mild, moderate, or severe. Classify by attribution as unrelated to protocol, possibly, probably, or definitely related to protocol.