Cycle with Biofeedback for Stroke

Overseen By Tamara Garff

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Contractures, Unstable angina, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cycling treatment with biofeedback to assist individuals who struggle with uneven walking after a stroke. The goal is to determine if this treatment can enhance balance and walking ability by providing real-time feedback on leg strength. Individuals who have experienced a specific type of stroke and have weakness in one leg may be suitable candidates, particularly if they can walk with some assistance but not independently. The trial will compare this new method with traditional rehabilitation treatments. As an unphased trial, it offers a unique opportunity to explore innovative rehabilitation methods that could improve recovery outcomes.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cycle with biofeedback is safe for stroke rehabilitation?

Research has shown that biofeedback cycling training has improved movement and quality of life in stroke patients. Importantly, these studies have not identified any safety problems. One study found that a 4-week biofeedback cycling program enhanced leg recovery and increased walking endurance and speed. This suggests that participants tolerate the treatment well. Overall, biofeedback cycling appears to be a safe and promising option for aiding stroke survivors with walking difficulties. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cycle with biofeedback for stroke rehabilitation because it combines traditional therapy with an innovative biofeedback approach. This treatment is distinct because it provides real-time feedback during cycling exercises, which can help patients better engage and improve motor function more effectively than traditional methods alone. By integrating biofeedback, patients might experience enhanced motivation and potentially faster recovery times, making it a promising addition to standard rehabilitation practices.

What evidence suggests that the cycle with biofeedback is effective for improving gait asymmetry poststroke?

Research has shown that using a bike with biofeedback can be very effective for stroke recovery. In this trial, participants in the "cycle with biofeedback" arm will undergo traditional rehabilitation therapies and participate in the cycle intervention with biofeedback. One study found that patients who used biofeedback cycling for four weeks had better leg function, could walk longer distances, and moved faster. Another study found that biofeedback helped stroke patients respond better to support compared to regular therapy. Real-time feedback on walking also improves how people walk after a stroke. Overall, biofeedback methods have increased muscle strength and improved walking ability in these patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Heather A Hayes, PhD

Principal Investigator

University of Utah

James C Martin, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are currently in an inpatient rehabilitation facility. It aims to help those with walking difficulties due to muscle weakness on one side of their body (hemiparesis). The eligibility criteria details are not fully provided.

Inclusion Criteria

Medical clearance to participate

I had a stroke confirmed by CT/MRI with weakness in my legs.

I need some help to walk or can walk independently on flat surfaces only.

Exclusion Criteria

My diabetes is not under control.

I have severe breathing problems that limit my physical activity.

Prior history of peripheral or central nervous system injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo traditional rehabilitation therapies and participate in the cycle intervention with biofeedback

2 weeks

Daily sessions

Follow-up

Participants are monitored for changes in cycling power and gait symmetry post-intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cycle with Biofeedback

Trial Overview The study tests the effects of using a recumbent cycle with power biofeedback versus traditional methods on improving how evenly patients use their leg muscles during walking and other functional outcomes after a stroke.

How Is the Trial Designed?

Group I: cycle with biofeedback Experimental Treatment 1 Intervention

Participants will undergo traditional rehabilitation therapies in the inpatient rehabilitation facility. They will also participate in the cycle intervention with biofeedback. This will take place as an additional rehabilitation session.

Group II: Traditional rehabilitation Active Control 1 Intervention

Participants will undergo traditional rehabilitation therapies in the inpatient rehabilitation facility.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Biofeedback cycling training significantly improved lower limb functional recovery, walking endurance, and walking speed in 31 patients with chronic stroke, as evidenced by better scores in various assessments during the cycling training period compared to the noncycling period.

The study demonstrated that the improvements were statistically significant across multiple measures, including the Fugl-Meyer assessment and walking tests, indicating that incorporating cycling training into rehabilitation can enhance recovery outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of biofeedback cycling training on functional recovery and walking ability of lower extremity in patients with stroke. Yang, HC., Lee, CL., Lin, R., et al.[2016]

A 2-week biofeedback pedaling treatment for chronic stroke patients showed significant improvements in pedaling balance, with all three participants maintaining these gains at follow-up.

Two out of the three patients also exhibited positive changes in their walking patterns, suggesting that this low-cost and safe intervention could enhance home rehabilitation for stroke survivors if validated in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel biofeedback cycling training to improve gait symmetry in stroke patients: a case series study. Ambrosini, E., Ferrante, S., Pedrocchi, A., et al.[2016]

In a study involving 245 stroke survivors with balance disorders, the biofeedback approach significantly improved stability, motion rates, and overall quality of life after five treatment sessions.

Patients also experienced reductions in pain, anxiety, and depression, indicating that biofeedback not only aids in physical rehabilitation but also enhances mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in kinesiostabilogram parameters and movement speed of stroke patients while increasing their physical activity due to the use of biofeedback method. Zaborova, V., Fesyun, A., Gurevich, K., et al.[2022]

Cycling leg exercise has shown promising results as a rehabilitation method for stroke patients, improving motor abilities in both subacute and chronic stages of recovery.

The review highlights the need for larger, standardized studies to better compare the effectiveness of cycling rehabilitation protocols, as current research shows significant variability in patient characteristics and assessment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of cycling and cycling combined with feedback in the rehabilitation of stroke patients: a review. Barbosa, D., Santos, CP., Martins, M.[2016]

Biofeedback therapy, when combined with conventional therapy, can lead to a small improvement in upper limb motor function for individuals recovering from a stroke, based on a systematic review of 16 studies.

However, the evidence quality is very low, and some analyses showed no significant advantage of adding biofeedback to conventional therapy, indicating that more high-quality research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback interventions for short term upper limb function following stroke: A systematic review with meta-analysis. Bonini-Rocha, AC., de Andrade, ALS., Santos Pereira, RD., et al.[2023]

Biofeedback is an effective therapy that helps patients learn to control physiological functions by providing real-time feedback on various bodily responses, such as muscle activity and heart rate.

This therapy is recognized as effective for treating several medical conditions and is gaining popularity among both patients and healthcare providers, highlighting its growing acceptance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback: an overview in the context of heart-brain medicine. McKee, MG.[2019]

Biofeedback can be beneficial in stroke rehabilitation, particularly for functions that are less observable, such as swallowing or attention, suggesting that its effectiveness may depend on the nature of the function being targeted.

In addition to direct improvements in physical function, biofeedback can enhance self-confidence and promote a sense of control in patients, which are important factors for overall success in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of biofeedback in stroke rehabilitation: past and future directions. Nelson, LA.[2022]

A comprehensive biofeedback program for post-stroke patients showed improvements in emotional status, daily activities, and overall quality of life after six months, despite no significant changes in motor function of the paretic hand.

Cognitive function assessments indicated stable results for three months, but some decline was observed after six months, suggesting that repeated treatment courses may be beneficial to maintain cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The impact of a comprehensive support response biofeedback program on patient recovery and quality of life after stroke]. Kotov, SV., Isakova, EV., Egorova, YV.[2022]

A comprehensive neurorehabilitation program using biofeedback significantly improved support responses in 59 post-stroke patients compared to standard therapy, indicating its efficacy in rehabilitation.

Patients in the biofeedback group experienced increased strength, reduced spasticity in the affected arm, and improvements in anxiety, depression, and cognitive functions, showcasing the program's holistic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency of a comprehensive program with biological feedback on support reaction in the restoring period of stroke]. Kotov, SV., Egorova, YV., Isakova, EV.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11916478/

Effect of biofeedback cycling training on functional recovery ... The study result indicates that the additional 4‐week biofeedback cycling training could lead to improved LE functional recovery, walking endurance, and speed ...

2. withpower.com withpower.com/trial/cycle-with-biofeedback-for-stroke-c18c7

Cycle with Biofeedback for Stroke A comprehensive neurorehabilitation program using biofeedback significantly improved support responses in 59 post-stroke patients compared to standard therapy, ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.637199/full

Biofeedback for Post-stroke Gait Retraining: A Review of ... Real-time gait biofeedback is a promising rehabilitation strategy for improving biomechanical deficits in walking patterns of post-stroke individuals.

4. ahajournals.org ahajournals.org/doi/10.1161/01.STR.25.6.1189

Rehabilitation of walking with electromyographic ... Our data confirm that the electromyographic biofeedback technique increases muscle strength and improves recovery of functional locomotion in patients with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1836955311700352

Biofeedback improves activities of the lower limb after stroke In the short-term, biofeedback improved lower limb activities compared with usual therapy/placebo (SMD = 0.49, 95% CI 0.22 to 0.75). Lower limb activities were ...

6. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/1743-0003-8-47

A biofeedback cycling training to improve locomotion: a case ... The aim of this study was to explore the feasibility of a biofeedback pedaling treatment and its effects on cycling and walking ability in chronic stroke ...