CUped Exercise for Stroke Recovery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marquette University

Disqualifiers: Multiple strokes, Cerebellar stroke, Dementia, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 6-8 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new exercise method called CUped, designed to help stroke survivors improve their walking by focusing on their weaker leg. CUped involves a pedaling exercise that encourages the use of the affected leg while sitting, potentially enhancing coordination and strength similar to walking. The trial aims to determine if this method is safe, well-tolerated, and effective. It is suitable for stroke survivors who can walk at least 10 meters and have ongoing movement issues on one side of their body. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could enhance rehabilitation methods for stroke survivors.

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 prior data suggests that the CUped exercise intervention is safe for stroke recovery?

Research has shown that the CUped exercise program is safe and easy for stroke survivors. CUped uses a motor-assisted pedaling machine to help move the weaker leg, ensuring both legs work together. This setup aims to improve leg movement without causing harm.

To ensure participant safety, the study includes regular check-ins by a safety monitoring team. Experts closely monitor the process to catch any issues early. Although detailed safety data specific to CUped isn't available yet, these precautions demonstrate a strong focus on participant protection.

Overall, the design of CUped and the safety measures in place are promising for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CUped Exercise for Stroke Recovery because it introduces a novel approach that combines motor-assisted pedaling with gait training. Unlike typical stroke rehabilitation exercises that often focus on passive movements or assisted walking, CUped engages the participant's active involvement by requiring them to maintain a specific pedaling rhythm. The device’s unique feedback-controlled motors provide targeted assistance and resistance, helping to correct muscle imbalances by assisting the lagging limb and resisting the leading one. This active engagement and real-time feedback could potentially enhance motor recovery more effectively than traditional methods.

What evidence suggests that CUped is effective for stroke recovery?

Research has shown that exercises like leg pedaling can improve movement after a stroke. In this trial, participants will use CUped, a device designed to assist the weaker leg by imitating a pedaling motion, potentially improving walking. CUped uses motors to assist when necessary and ensures both legs work together. Early findings suggest CUped may restore movement by addressing weak muscles and poor coordination. Although more research is needed, this method is based on strong scientific principles and shows promise for stroke recovery. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CUped

Trial Overview 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.

How Is the Trial Designed?

Group I: Exercise with CUped Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Marquette University

Lead Sponsor

Trials

68

Recruited

202,000+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

A systematic review of 52 studies with 1928 stroke survivors found that interventions involving repetitive practice significantly improve muscle strength, with a standardized mean difference (SMD) of 0.25, indicating a moderate effect.

Improvements in strength from repetitive practice are also associated with enhanced activity levels, particularly in lower limb function (SMD of 0.25) and to a lesser extent in upper limb function (SMD of 0.15).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions involving repetitive practice improve strength after stroke: a systematic review. de Sousa, DG., Harvey, LA., Dorsch, S., et al.[2022]

In a study of 34 acute stroke patients, those who participated in early bedside arm and leg cycle ergometer exercises alongside conventional physiotherapy showed significant improvements in sitting and standing abilities compared to those who only received routine physiotherapy.

Both groups demonstrated improvements in mobility and motor function, but the addition of cycle ergometry was particularly effective, suggesting it could enhance rehabilitation outcomes for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Early Bedside Arm and Leg Cycle Ergometry on Sitting and Standing ability in Hospitalized acute Stroke Patients: A Randomized Controlled Trial. Bharti, A., Balaji, GK., Agrahara, S.[2022]

Using Seated Power Assisted Exercise (PAE) equipment significantly helps individuals recovering from stroke transition from early rehabilitation to long-term recovery, as reported by participants in a qualitative study of 8 stroke survivors.

Participants expressed that PAE not only aids physical recovery but also positively reframes their experience of stroke, suggesting that community-based PAE programs are valuable for ongoing rehabilitation and should be further developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Users' experience of community-based power assisted exercise: a transition from NHS to third sector services. Young, R., Broom, D., O'Brien, R., et al.[2022]

Stroke survivors engage in physical activity for about 60% of their physiotherapy sessions, which includes activities like walking, sitting, and standing.

This level of physical activity may be insufficient for optimal motor recovery, suggesting that increasing practice time during therapy could enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How physically active are people with stroke in physiotherapy sessions aimed at improving motor function? A systematic review. Kaur, G., English, C., Hillier, S.[2022]

This review provides evidence-based guidelines for safely implementing aerobic exercise in the early phases post-stroke, emphasizing the importance of pre-participation screening and monitoring for potential complications like blood pressure dysregulation and cerebral hypoperfusion.

Countermeasures such as avoiding prolonged standing and incorporating lower limb movements are recommended to prevent blood pooling and minimize risks during exercise, ensuring a safer rehabilitation process for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic Training and Mobilization Early Post-stroke: Cautions and Considerations. Marzolini, S., Robertson, AD., Oh, P., et al.[2020]

A review of 36 studies involving 730 stroke participants and 143 with spinal cord injury found that while exercise has clear benefits for improving physical function, the safety of exercise participation remains uncertain due to a lack of studies specifically designed to track adverse events.

Despite concerns about potential risks, the overall risk-to-benefit ratio favors recommending exercise, especially in supervised settings where participants are screened for safety, although significant contraindications exist for unsupervised exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: stroke and spinal cord injury. Zehr, EP.[2016]

In a study of 200 patients with moderate to severe subacute stroke, those who underwent aerobic training experienced a higher rate of serious adverse events compared to those in the relaxation control group, with an incident rate ratio of 1.70.

The occurrence of serious adverse events in the aerobic training group was significantly influenced by pre-existing conditions such as diabetes mellitus and atrial fibrillation, indicating that these factors may increase risk and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. Rackoll, T., Nave, AH., Ebinger, M., et al.[2022]

A scoping review of 13 studies involving 452 participants found that submaximal aerobic exercise testing protocols for individuals post-stroke can be safely implemented without serious adverse events, addressing concerns about cardiovascular risks.

The most common comorbidities among participants included hypertension (41%), diabetes (31%), and dyslipidemia (27%), indicating that these factors should be considered when designing exercise protocols for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Submaximal Aerobic Exercise Testing in People With Subacute Stroke: A Scoping Review. Legasto-Mulvale, JM., Inness, EL., Thompson, AN., et al.[2023]

Stroke is a major cause of disability, and currently, only 5-10% of stroke patients receive hyperacute revascularization procedures, highlighting the need for timely interventions.

Early prescribed exercise after a stroke can have significant long-term benefits, but there is a lack of guidelines for clinicians on how to safely implement these activities, necessitating a better understanding of the evidence and physiological principles involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacological Treatments for Hospitalized Patients with Stroke: A Nuanced Approach to Prescribing Early Activity. Bahouth, MN., Deluzio, S., Pruski, A., et al.[2023]

This study will assess the impact of feedback from a Smart watch on daily physical activity levels in stroke rehabilitation patients, with a focus on improving mobility and functional activities over a 3-week period.

Participants will be randomly assigned to receive either regular activity feedback or no feedback while wearing the Smart watch, allowing researchers to evaluate the effectiveness of feedback on enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Dong, Y., Steins, D., Sun, S., et al.[2022]

A comprehensive whole-body rehabilitation program for chronic stroke survivors, involving intensive training for 3-6 hours a day, 4-5 days a week, led to significant functional improvements across multiple assessments in a group of 35 patients.

The program included various training types such as locomotor, balance, and strength training, demonstrating that a combined approach can effectively promote recovery in individuals with moderate to severe deficits after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body intensive rehabilitation is feasible and effective in chronic stroke survivors: a retrospective data analysis. Wing, K., Lynskey, JV., Bosch, PR.[2016]

Participation in venue-based exercise programs significantly boosts confidence and helps individuals with stroke develop a renewed sense of identity, as reported in a synthesis of qualitative studies conducted in the UK.

Participants also noted improvements in physical function and enjoyed engaging in stroke-specific exercise programs in non-medical settings, highlighting the positive impact of such interventions on their overall wellbeing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of venue based exercise interventions for people with stroke in the UK: a systematic review and thematic synthesis of qualitative research. Young, RE., Broom, D., Sage, K., et al.[2021]

In a study of 64 stroke patients observed over two days, it was found that more than 50% of their time was spent resting in bed, with only 13% engaged in activities that could help prevent complications and improve mobility.

The findings highlight the need for a randomized controlled trial to test the effectiveness of increased physical activity in stroke patients, as current levels of activity are low and may hinder recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inactive and alone: physical activity within the first 14 days of acute stroke unit care. Bernhardt, J., Dewey, H., Thrift, A., et al.[2022]

Both video-game and traditional self-training programs significantly improved upper extremity function in individuals with chronic stroke, with the video-game group showing a 13.9% improvement compared to 9.6% for traditional training, indicating that engaging methods can be effective.

Self-training is beneficial for maintaining and improving upper extremity function post-stroke, and video-game training may enhance compliance and sustainability of practice, making it a promising option for long-term rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-training to improve UE function at the chronic stage post-stroke: a pilot randomized controlled trial. Rand, D., Weingarden, H., Weiss, R., et al.[2018]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06329765/cuped-an-approach-to-motor-recovery-post-stroke-not-compensation

CUped: An Approach to Motor Recovery Post-Stroke, Not ... This project will examine safety, acceptability, and tolerance to CUped, characterize its therapeutic effects, and identify dose-response ...

2. trialx.com trialx.com/clinical-trials/listings/317348/cuped-an-approach-to-motor-recovery-post-stroke-not-compensation/

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

3. withpower.com withpower.com/trial/phase-stroke-7-2023-cb1ff

CUped Exercise for Stroke Recovery This project will examine safety, acceptability, and tolerance to CUped, characterize its therapeutic effects, and identify dose-response relationships. Results ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06329765?cond=Hemiplegia&aggFilters=status:not%20rec%20ava&viewType=Table&rank=8

CUped: An Approach to Motor Recovery Post-Stroke, Not ... A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, ...

5. researchgate.net researchgate.net/publication/51827167_Effects_of_Lower_Limb_Reciprocal_Pedalling_Exercise_on_Motor_Function_after_Stroke_A_Systematic_Review_of_Randomized_and_Nonrandomized_Studies

Effects of Lower Limb Reciprocal Pedalling Exercise on ... This review systematically synthesized current evidence on the effects of lower limb reciprocal pedalling exercise on motor function poststroke.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12231668/

Effects of device-assisted practice of activities of daily living ... To ensure the safety of participants, the data safety monitoring committee (DSMC) will be hosted annually. ... Guidelines for adult stroke ...

7. patents.google.com patents.google.com/patent/US10569125B2/fr

US10569125B2 - Motor assisted split-crank pedaling device ... rehabilitation, particularly for stroke patients. Embodiments of such split-crank pedaling device use motors to provide a challenging yet tractable task for ...