Actively Recruiting
CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation
Led by Marquette University · Updated on 2025-09-30
12
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Marquette University
Lead Sponsor
M
Medical College of Wisconsin
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a novel exercise therapy called CUped to help stroke survivors recover movement in their lower limbs and improve walking ability. Stroke often causes persistent movement problems and few survivors regain independent walking. CUped targets key movement impairments after stroke using a robotic device to encourage use of the affected leg and reduce compensatory movements. This study aims to test CUped's safety, acceptability, tolerance, and therapeutic effects, providing data to support a future randomized controlled trial. Participants will complete 24 exercise sessions using the CUped device, which involves pedaling with both legs on a split-crank apparatus where motors assist or resist limbs to maintain proper movement timing. Each session includes up to 12 bouts of bilateral uncoupled pedaling, followed by one bout of overground walking training. The exercise is done while sitting to allow high repetition practice and focuses on restoring muscle output, timing, and coordination. Researchers will monitor exercise dose and response throughout the 6-8 week training period. During the study, participants will undergo assessments before, during, and after training to measure paretic limb use and coordination during walking and pedaling. Safety will be tracked through adverse event monitoring and session attendance. Muscle activity and physiological responses such as heart rate and blood pressure will also be measured. The study involves 27 visits including pretest, midtest, posttest, and training sessions, aiming to establish whether CUped is safe, well tolerated, and can elicit therapeutic benefits for stroke survivors.
CONDITIONS
Brief Title
CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Single, unilateral stroke in adulthood.
- Stroke can be cortical or subcortical, including ischemic or hemorrhagic types.
- Stroke occurred more than 6 months ago (chronic stroke).
- Able to walk at least 10 meters overground, with or without assistive devices.
- Unilateral motor impairment consistent with hemiparesis.
- Verified learned non-use of the affected leg.
- No contraindications to exercise such as recent heart problems or severe orthopedic issues.
- At least 18 years old.
- Able to commit to 27 lab visits including testing and training sessions.
You will not qualify if you...
- History of more than one clinically apparent stroke.
- Stroke affecting primarily the cerebellum or basal ganglia.
- Dementia or cognitive impairment that hinders learning or consent.
- Communication impairments that prevent safe participation (except expressive aphasia).
- Orthopedic impairments interfering with pedaling.
- Cardiovascular conditions that contraindicate exercise.
- Unable to safely walk 10 meters overground.
- Neurological disorders other than stroke.
- Any other condition that increases risk or could affect study results.
- Failure to meet any inclusion criteria.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants must commit to 27 lab visits including testing and training sessions.
Duration - 6 to 8 weeks
Participants exercise with CUped, a motor-assisted, split crank pedaling device, and then perform 50 meters of gait training. This treatment targets recovery of lower limb movement lost to stroke by compeling use of the paretic limb and improving interlimb coordination through up to 24 exercise sessions.
Up to 24 training sessions over 6 weeks
Trial Site Locations
Total: 1 location
1
Marquette University
Milwaukee, Wisconsin, United States, 53201
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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