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

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{5 11 12 13 14}

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Inactive and alone: physical activity within the first 14 days of acute stroke unit care. [2022]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Self-training to improve UE function at the chronic stage post-stroke: a pilot randomized controlled trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Whole-body intensive rehabilitation is feasible and effective in chronic stroke survivors: a retrospective data analysis. [2016]

5. India 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Nonpharmacological Treatments for Hospitalized Patients with Stroke: A Nuanced Approach to Prescribing Early Activity. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse Events During Submaximal Aerobic Exercise Testing in People With Subacute Stroke: A Scoping Review. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Aerobic Training and Mobilization Early Post-stroke: Cautions and Considerations. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Users' experience of community-based power assisted exercise: a transition from NHS to third sector services. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

How physically active are people with stroke in physiotherapy sessions aimed at improving motor function? A systematic review. [2022]

13. England 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. [2021]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Interventions involving repetitive practice improve strength after stroke: a systematic review. [2022]