protocolSection identificationModule nctId: NCT06329765, orgStudyIdInfo id: HR- 4380, briefTitle: CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-07, primaryCompletionDateStruct date: 2025-04-04, completionDateStruct date: 2025-04-04, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Marquette University, class: OTHER, collaborators name: Medical College of Wisconsin, descriptionModule briefSummary: The goal of lower limb rehabilitation after stroke is recovery of independent walking at home and in the community. Few stroke survivors achieve this goal. Suboptimal outcomes are due to the serious and intransigent nature of movement impairments caused by stroke and the scarcity of feasible and effective therapies that restore movement lost to stroke. Our team has developed a novel exercise intervention called CUped (pronounced cupid, like the Roman god) to address barriers to recovery and improve walking after stroke. CUped is so called because it compels use of the paretic limb during a movement that resembles pedaling. This project will examine safety, acceptability, and tolerance to CUped, characterize its therapeutic effects, and identify dose-response relationships. Results will provide preliminary data for an R01 to support a randomized controlled trial (RCT). CUped is designed to help stroke survivors recover lower limb movement lost to stroke, thereby improving walking. It is intended to be used as an adjunct to gait training. CUped uses a robotic technology that eliminates compensatory movements that interfere with recovery, compels use of the paretic lower limb, and targets 3 key movement impairments caused by stroke: decreased muscle output from the paretic limb, inappropriate paretic muscle timing, and abnormal interlimb coordination. Exercise is done in sitting which enables high repetition practice. Like walking, CUped requires continuous, reciprocal use of both lower limbs; effects are likely to transfer to walking. The risk-reward profile of this proposal is ideal for an R21, which is an NIH funding opportunity intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. CUped is a novel therapy grounded in a physiologic premise and based on prior observations from our laboratory. The investigators have pilot data suggesting that CUped fulfills its design specifications, and this study will be the first to test its therapeutic effects. In this Stage 1 rehabilitation trial, The investigators will support or quickly refute the hypothesis that CUped is safe, acceptable, and capable of eliciting a therapeutic response in stroke survivors. The investigators will also examine tolerance to CUped and dose-response effects. If our hypotheses are supported, the investigators will be poised to run an RCT to isolate the effects of CUped and compare them to standard care. Future work will investigate physiologic mechanisms underlying the effects of CUped., conditionsModule conditions: Stroke, conditions: Hemiplegia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group pretest-posttest, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Exercise with CUped - a motor-assisted, split crank pedaling device and undergo 50 m of gait training., outcomesModule primaryOutcomes measure: Paretic limb use in walking, primaryOutcomes measure: Paretic limb use in pedaling, primaryOutcomes measure: Interlimb coordination in walking, primaryOutcomes measure: Interlimb coordination in pedaling, primaryOutcomes measure: Motorized intervention during pedaling split-crank (i.e., bilateral uncoupled) pedaling, primaryOutcomes measure: Absences, primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Muscle activity - timing, secondaryOutcomes measure: Muscle activity - amplitude, secondaryOutcomes measure: Physiological response to exercise - Blood pressure, secondaryOutcomes measure: Physiological response to exercise - Heart rate, secondaryOutcomes measure: Physiological response to exercise - Rate of perceived exertion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marquette University, status: RECRUITING, city: Milwaukee, state: Wisconsin, zip: 53201, country: United States, contacts name: SHEILA M SCHINDLER-IVENS, PhD, role: CONTACT, phone: 414-288-7282, email: sheila.schindler-ivens@marquette.edu, geoPoint lat: 43.0389, lon: -87.90647, hasResults: False