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

Trial Summary

What is the purpose of this trial?

To determine changes in power symmetry, gait symmetry, and functional outcomes for participants' poststroke (Inpatient Rehabilitation Facility) after participating in an intervention using a recumbent cycle with power biofeedback (BFB). To determine how this intervention can impact gait asymmetry, a common disorder poststroke secondary to hemiparesis. Gait asymmetry is a difficult impairment to treat because it is difficult for both therapists and patients to perceive. Training with BFB allows for quantitative data about the power production or lack of that directly impacts safety in walking, increased energy expenditure, and decreased gait speed.

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 data supports the effectiveness of the treatment Cycle with Biofeedback for stroke patients?

Research shows that biofeedback cycling training can improve walking ability and lower limb function in stroke patients. Studies found that patients who used biofeedback cycling had better recovery in walking speed and endurance compared to those who did not use it. ^{1 2 3 4 5}

Is biofeedback cycling training safe for humans?

Biofeedback cycling training has been used in studies with stroke patients and has shown improvements in mobility and quality of life without reported safety concerns. It is generally considered safe and is increasingly accepted by healthcare providers. ^{1 2 4 6 7}

How does the Cycle with Biofeedback treatment differ from other stroke treatments?

Cycle with Biofeedback is unique because it combines cycling exercises with real-time feedback to help stroke patients improve their walking ability and balance. This approach is different from traditional rehabilitation as it uses visual cues to promote symmetrical pedaling, which can enhance motor function recovery and walking endurance. ^{2 3 4 8 9}

Research Team

James C Martin, PhD

Principal Investigator

University of Utah

Heather A Hayes, PhD

Principal Investigator

University of Utah

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The impact of a comprehensive support response biofeedback program on patient recovery and quality of life after stroke]. [2022]

2. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Effect of biofeedback cycling training on functional recovery and walking ability of lower extremity in patients with stroke. [2016]

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

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

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

A novel biofeedback cycling training to improve gait symmetry in stroke patients: a case series study. [2016]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Efficiency of a comprehensive program with biological feedback on support reaction in the restoring period of stroke]. [2022]

6. Italy 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. [2022]

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

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

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

The application of cycling and cycling combined with feedback in the rehabilitation of stroke patients: a review. [2016]

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

Biofeedback interventions for short term upper limb function following stroke: A systematic review with meta-analysis. [2023]