NCT06329765

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

Recruiting now NA Last updated 30 September 2025

What this trial tests

NA trial testing Exercise with CUped - a motor-assisted, split crank pedaling device and undergo 50 m of gait training. in Stroke in 12 participants. Currently enrolling.

Timeline

7 August 2023

Primary endpoint
4 April 2026

4 April 2027

Quick facts

Lead sponsor	Marquette University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	7 August 2023
Primary completion	4 April 2026
Estimated completion	4 April 2027
Sites	1 location across United States

Drugs / interventions tested

• Exercise with CUped - a motor-assisted, split crank pedaling device and undergo 50 m of gait training.

Conditions studied

• Stroke — all drugs for Stroke →
• Hemiplegia — all drugs for Hemiplegia →

Sponsor

Marquette University

Who can join

Adults 18 to 100, any sex, with Stroke or Hemiplegia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.