CUped Exercise for Stroke Recovery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Marquette University
Disqualifiers: Multiple strokes, Cerebellar stroke, Dementia, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment CUped for stroke recovery?
Research suggests that early mobilization and physical activity, such as using a cycle ergometer or feedback from a Smart watch, can improve recovery after a stroke by enhancing mobility and functional activities. These findings imply that treatments promoting physical activity, like CUped, may be beneficial for stroke recovery.
12345Is the CUped Exercise for Stroke Recovery generally safe for humans?
Exercise after a stroke is generally considered safe when properly supervised and tailored to the individual's condition. Safety guidelines emphasize the importance of pre-participation screening and monitoring to prevent adverse events, especially in the early phases of stroke recovery.
678910How does the CUped Exercise treatment for stroke recovery differ from other treatments?
The CUped Exercise treatment for stroke recovery is unique because it involves early bedside arm and leg cycle ergometer exercises, which may enhance sitting and standing abilities more effectively than routine physiotherapy. This approach focuses on early intervention and specific repetitive exercises, which are not typically emphasized in standard stroke recovery treatments.
511121314Eligibility Criteria
This trial is for stroke survivors with hemiplegia, aiming to help them recover lower limb movement and improve walking. Participants should be able to perform the exercise with CUped—a motor-assisted device—and undergo gait training.Inclusion Criteria
I had one stroke as an adult.
I have had a stroke caused by a clot or bleed.
I can walk 10 meters by myself or with help like a cane.
+7 more
Exclusion Criteria
I have had a stroke in the back part of my brain or deep brain areas.
I have heart conditions that prevent me from exercising.
I have a neurological condition that is not a stroke.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants exercise with CUped, a motor-assisted, split crank pedaling device, and undergo gait training
6-8 weeks
24 exercise sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests CUped, a novel robotic technology designed to enhance recovery of leg movements post-stroke by eliminating compensatory actions. It's paired with gait training to potentially transfer benefits to walking ability.
1Treatment groups
Experimental Treatment
Group I: Exercise with CUpedExperimental Treatment1 Intervention
Participants will exercise with CUped (a motor-assisted, split crank pedaling device) and undergo 50 m of gait training. CUped comprises a left and right pedal; each is attached to the shaft of a motor. There is no mechanical connection between pedals. Participant's feet are secured to the pedals. They are asked to pedal forward and keep the legs 180° out-of-phase. The position of the left and right cranks is monitored. When the phase relationship is not maintained, motors provide torque to assist the lagging limb and resist the leading limb. Motors are under feedback control. Torque is proportional to the magnitude and sign of the error.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Marquette UniversityMilwaukee, WI
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Who Is Running the Clinical Trial?
Marquette UniversityLead Sponsor
Medical College of WisconsinCollaborator
References
Inactive and alone: physical activity within the first 14 days of acute stroke unit care. [2022]One way that stroke units may improve outcome is by reducing complications of immobility through early mobilization; however, this intervention needs testing. The purpose of this study was to determine the physical activity patterns of stroke patients managed within acute stroke units as a first step in developing an early mobilization protocol.
Does feedback on daily activity level from a Smart watch during inpatient stroke rehabilitation increase physical activity levels? Study protocol for a randomized controlled trial. [2022]Practicing activities improves recovery after stroke, but many people in hospital do little activity. Feedback on activity using an accelerometer is a potential method to increase activity in hospital inpatients. This study's goal is to investigate the effect of feedback, enabled by a Smart watch, on daily physical activity levels during inpatient stroke rehabilitation and the short-term effects on simple functional activities, primarily mobility.
Self-training to improve UE function at the chronic stage post-stroke: a pilot randomized controlled trial. [2018]On-going practice and use of the weaker upper extremity (UE) are important for maintaining and improving function in individuals with chronic stroke. The effectiveness of two self-training programs for UE function and daily-use was compared.
Whole-body intensive rehabilitation is feasible and effective in chronic stroke survivors: a retrospective data analysis. [2016]Upper extremity (UE) intensive repetitive training, locomotor training, and functional strength training, delivered in isolation, promote neural plasticity and functional recovery after stroke. However, the effectiveness of a comprehensive whole-body approach combining these interventions has not been thoroughly investigated. The purpose of this retrospective data analysis was to evaluate the efficacy and feasibility of intensive, comprehensive rehabilitation for a heterogeneous population of chronic stroke survivors in a community clinic setting.
Effect of Early Bedside Arm and Leg Cycle Ergometry on Sitting and Standing ability in Hospitalized acute Stroke Patients: A Randomized Controlled Trial. [2022]The objective of this study was to evaluate the effect of early bedside arm and leg cycle ergometer exercises as compared to routine physiotherapy on sitting and standing ability in hospitalized acute stroke patients.
Nonpharmacological Treatments for Hospitalized Patients with Stroke: A Nuanced Approach to Prescribing Early Activity. [2023]Stroke remains a leading cause of adult disability. To date, hyperacute revascularization procedures reach 5-10% of stroke patients even in high resource health systems. There is a limited time window for brain repair after stroke, and therefore, the activities such as prescribed exercise in the earliest period will likely have long-term significant consequences. Clinicians who provide care for hospitalized stroke patients make treatment decisions specific to activity often without guidelines to direct these prescriptions. This requires a balanced understanding of the available evidence for early post-stroke exercise and physiological principles after stroke that drive the safety of prescribed exercise. Here, we provide a summary of these relevant concepts, identify gaps, and recommend an approach to prescribing safe and meaningful activity for all patients with stroke. The population of thrombectomy-eligible stroke patients can be used as the exemplar for conceptualization.
Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. [2022]To report the six-month safety analyses among patients enrolled in the "Physical Fitness Training in Subacute Stroke-PHYS-STROKE" trial and identify underlying risk factors associated with serious adverse events.
Adverse Events During Submaximal Aerobic Exercise Testing in People With Subacute Stroke: A Scoping Review. [2023]Concern for adverse cardiovascular events and limited guidance regarding how to conduct aerobic exercise (AEx) testing for individuals poststroke are key barriers to implementation by physical therapists in stroke rehabilitation. This study aimed to describe the nature and safety of submaximal AEx testing protocols for people with subacute stroke (PwSS) and the nature of comorbidity of PwSS who underwent submaximal AEx testing.
Aerobic Training and Mobilization Early Post-stroke: Cautions and Considerations. [2020]Knowledge gaps exist in how we implement aerobic exercise programs during the early phases post-stroke. Therefore, the objective of this review was to provide evidence-based guidelines for pre-participation screening, mobilization, and aerobic exercise training in the hyper-acute and acute phases post-stroke. In reviewing the literature to determine safe timelines of when to initiate exercise and mobilization we considered the following factors: arterial blood pressure dysregulation, cardiac complications, blood-brain barrier disruption, hemorrhagic stroke transformation, and ischemic penumbra viability. These stroke-related impairments could intensify with inappropriate mobilization/aerobic exercise, hence we deemed the integrity of cerebral autoregulation to be an essential physiological consideration to protect the brain when progressing exercise intensity. Pre-participation screening criteria are proposed and countermeasures to protect the brain from potentially adverse circulatory effects before, during, and following mobilization/exercise sessions are introduced. For example, prolonged periods of standing and static postures before and after mobilization/aerobic exercise may elicit blood pooling and/or trigger coagulation cascades and/or cerebral hypoperfusion. Countermeasures such as avoiding prolonged standing or incorporating periodic lower limb movement to activate the venous muscle pump could counteract blood pooling after an exercise session, minimize activation of the coagulation cascade, and mitigate potential cerebral hypoperfusion. We discuss patient safety in light of the complex nature of stroke presentations (i.e., type, severity, and etiology), medical history, comorbidities such as diabetes, cardiac manifestations, medications, and complications such as anemia and dehydration. The guidelines are easily incorporated into the care model, are low-risk, and use minimal resources. These and other strategies represent opportunities for improving the safety of the activity regimen offered to those in the early phases post-stroke. The timeline for initiating and progressing exercise/mobilization parameters are contingent on recovery stages both from neurobiological and cardiovascular perspectives, which to this point have not been specifically considered in practice. This review includes tailored exercise and mobilization prescription strategies and precautions that are not resource intensive and prioritize safety in stroke recovery.
Evidence-based risk assessment and recommendations for physical activity clearance: stroke and spinal cord injury. [2016]Physical activity (PA) has potential benefits after stroke or spinal cord injury (SCI), especially in improving efficiency and functional capacity in activities of daily living. Currently, many who could benefit from PA may be routinely excluded from participation because of myths related to functional capacity and the concern for harm. The purpose of this review was to evaluate the literature for reports of adverse events during exercise after stroke or SCI, and to provide recommendations regarding exercise participation in supervised and unsupervised environments. Studies were evaluated for quality, and the summary level and quality of evidence were evaluated using the AGREE rubric, modified to address the main outcome measure of adverse events. Levels of exercise stress were evaluated for aerobic activities, using an established rubric. Included in the current analysis were 32 studies for stroke and 4 for SCI. In aggregate, this yielded a total of 730 experimental participants with stroke and 143 with SCI. It should be noted that almost all studies were not designed to examine naturally occurring adverse events from PA. Significant contraindications to unsupervised exercise include manifestation of autonomic dysreflexia in SCI and cardiovascular comorbidity after stroke. There are clear benefits of exercise training on physiological outcomes in stroke and SCI, but the relation between outcomes and safety remains unclear. However, taken on balance, the risk-to-benefit ratio favors the recommendation of exercise. This recommendation is based on studies in which participants were almost universally screened for participation in supervised environments. Thus, the grading of evidence for finding adverse events to support this conclusion is inadequate.
Users' experience of community-based power assisted exercise: a transition from NHS to third sector services. [2022]Seated Power Assisted Exercise (PAE) equipment is an accessible exercise mode for people with limited mobility following stroke and is available at a small number of community-based venues. The purpose of this qualitative study was to understand the lived experience of using PAE amongst PwS in a community venue and identify recommendations for the development and advancement of PAE equipment.
How physically active are people with stroke in physiotherapy sessions aimed at improving motor function? A systematic review. [2022]Background. Targeted physical activity drives functional recovery after stroke. This review aimed to determine the amount of time stroke survivors spend physically active during physiotherapy sessions. Summary of Review. A systematic search was conducted to identify published studies that investigated the use of time by people with stroke during physiotherapy sessions. Seven studies were included; six observational and one randomised controlled trial. People with stroke were found to be physically active for an average of 60 percent of their physiotherapy session duration. The most common activities practiced in a physiotherapy session were walking, sitting, and standing with a mean (SD) practice time of 8.7 (4.3), 4.5 (4.0), and 8.3 (2.6) minutes, respectively. Conclusion. People with stroke were found to spend less than two-thirds of their physiotherapy sessions duration engaged in physical activity. In light of dosage studies, practice time may be insufficient to drive optimal motor recovery.
Experiences of venue based exercise interventions for people with stroke in the UK: a systematic review and thematic synthesis of qualitative research. [2021]The physical benefits of exercise following stroke are research evidenced and the UK stroke population is increasingly encouraged to engage with exercise interventions. A synthesis of qualitative research is required to further understand the perceived experience and psychosocial effect of exercise for people with stroke.
Interventions involving repetitive practice improve strength after stroke: a systematic review. [2022]Do interventions involving repetitive practice improve strength after stroke? Are any improvements in strength accompanied by improvements in activity?