Comprehensive Gait Rehabilitation for Post-Stroke Recovery

Overseen By Kristan Leech, PT, DPT, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Southern California

Disqualifiers: Cerebellar damage, Basal ganglia damage, Uncontrolled hypertension, Cognitive impairment, Orthopedic conditions, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help people regain walking ability after a stroke. It focuses on using biofeedback (real-time information on body movements) and aerobic exercises to improve walking patterns. The study will test various methods, such as interlimb asymmetry biofeedback, propulsive force biofeedback, step length biofeedback, and aerobic intensity-based walking, to determine the most effective approach. It targets individuals who had a stroke over six months ago, can walk independently, and are ready to engage in exercise activities. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to experience these innovative methods.

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 comprehensive gait rehabilitation approach is safe for post-stroke recovery?

Studies have shown that using biofeedback to assist with walking is a promising method for improving gait after a stroke. Research indicates that real-time feedback on aspects like step length and balance can lead to immediate improvements. This approach is generally safe and well-tolerated by patients.

Strong evidence supports the safety of exercises focused on aerobic intensity. High-intensity interval training (HIT) and moderate-intensity exercises have been used in stroke recovery, showing improvements in walking distance and balance without major safety concerns.

Although this clinical trial is still in the early stages, past studies have demonstrated the safety and effectiveness of the individual components of the treatment. This suggests that the treatments as a whole should be well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to help stroke survivors regain their walking abilities. Unlike traditional rehabilitation, which often focuses on general physical therapy and strength training, this trial uses biofeedback to specifically target gait issues like step length, propulsive force, and interlimb asymmetry. By providing real-time feedback, participants can adjust their movements to improve their walking pattern more effectively. Additionally, the trial examines how different levels of aerobic intensity affect the use of biofeedback, offering insights into personalized rehabilitation plans. These new approaches could lead to more effective, tailor-made recovery strategies for stroke survivors.

What evidence suggests that this trial's treatments could be effective for post-stroke recovery?

Research has shown that biofeedback can greatly improve how stroke survivors walk. In this trial, participants will engage in different treatment arms to evaluate the effects of biofeedback on walking. Studies have found that real-time feedback on leg movement, the force used to push off the ground, and the length of each step helps correct walking problems. For example, feedback on the force used to push off has led to quick improvements in walking. Additionally, more intense walking exercises, like high-intensity interval training, have improved movement and balance more than moderate exercise. These findings suggest that combining biofeedback with aerobic exercise could effectively enhance walking abilities after a stroke. ^{1 2 4 5 6}

Who Is on the Research Team?

Kristan Leech, PT, DPT, PhD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for individuals who are more than 6 months post-stroke, affecting one side of the brain. They must be able to walk independently (with or without assistive devices) for at least 5 minutes and have a physician's clearance. Pregnant women, those with certain brain damages, uncontrolled high blood pressure, low cognitive scores, or severe orthopedic conditions cannot participate.

Inclusion Criteria

I can walk on my own or with help from devices.

It has been over 6 months since I had a stroke that affected one side of my brain.

You are ready for exercise based on your answers to the PAR-Q+ questionnaire.

Exclusion Criteria

I have a condition related to my bones or pain.

Your Montreal Cognitive Assessment score is less than 25.

My blood pressure is not higher than 160/100 mmHg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo biofeedback-based gait training and aerobic exercise intensity-based gait training to reduce interlimb asymmetry

8 weeks

3 experimental sessions for Aim 1, 1 session for Aim 2

Follow-up

Participants are monitored for retention of gait improvements and safety after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic intensity-based walking
• Interlimb asymmetry biofeedback
• Propulsive force biofeedback
• Step length biofeedback

Trial Overview

The study tests a new gait training method combining biofeedback (on step length and limb symmetry) with aerobic exercise intensity-based walking in chronic stroke survivors. The aim is to find out how feasible this approach is and what the best settings are for these exercises.

How Is the Trial Designed?

Group I: Reducing interlimb asymmetry with biofeedback post-stroke Experimental Treatment 3 Interventions

We will use a randomized crossover design to determine the performance and retention effects following single-day training sessions with biofeedback of three different gait variables (i.e., step length, propulsive force, and interlimb asymmetry) in 25 individuals with chronic stroke.

Group II: Evaluating capacity for biofeedback use at varied intensities Experimental Treatment 1 Intervention

We will use a within-session randomized crossover design to test the capacity of persons post-stroke (second cohort; n=25) to reduce their interlimb asymmetry using the biofeedback variable found to be the most effective for the group in Aim 1 while walking in three aerobic intensity zones: low, moderate, and vigorous (30-40%, 50-60%, and 70-80% of heart rate reserve, respectively).

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

A study involving 7 able-bodied individuals showed that real-time visual and auditory biofeedback can significantly increase the push-off force (anteriorly-directed ground reaction force, AGRF) in a targeted leg during walking, indicating the effectiveness of this training method.

The increased push-off force was maintained even after short breaks, suggesting that the training could help individuals with gait deficits, like those recovering from a stroke, by reinforcing specific walking patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of unilateral real-time biofeedback on propulsive forces during gait. Schenck, C., Kesar, TM.[2019]

Real-time biofeedback, using audio, visual, or both, significantly improves peak anterior ground reaction force (AGRF) during gait in both able-bodied and post-stroke individuals, indicating its efficacy in rehabilitation.

There was no significant difference in AGRF improvement among the different biofeedback modes, suggesting that any of these methods can be effectively used for gait rehabilitation post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Immediate Effects of Audio, Visual, or Audiovisual Gait Biofeedback on Propulsive Force Generation in Able-Bodied and Post-stroke Individuals. Liu, J., Kim, HB., Wolf, SL., et al.[2021]

Rhythmic stimulation, whether through vibrotactile or auditory methods, significantly improves stance time symmetry ratio (STSR) in healthy adults with induced gait asymmetry, suggesting its potential for gait rehabilitation.

Both types of rhythmic stimulation were equally effective in enhancing gait parameters, indicating that either method could be used to aid individuals with mobility impairments in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Short-Term Effects of Rhythmic Vibrotactile and Auditory Biofeedback on the Gait of Individuals After Weight-Induced Asymmetry. Michelini, A., Sivasambu, H., Andrysek, J.[2023]

A new biofeedback gait training system effectively helps stroke patients correct walking asymmetries by using lighted targets to guide step length, providing real-time visual and auditory feedback.

In a study involving hemiparetic patients, those using the biofeedback method showed significant improvements in step length and reduced asymmetry compared to those using traditional rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Step-length biofeedback device for walk rehabilitation. Montoya, R., Dupui, P., Pagès, B., et al.[2019]

Gait biofeedback shows promise in improving walking patterns for post-stroke individuals, but current studies are inconsistent in methodology, highlighting the need for larger, more uniform trials to better understand its effectiveness.

Wearable sensor technologies could enhance gait biofeedback applications, making it more accessible for telehealth and home rehabilitation, which may improve the quality of rehabilitation while reducing costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback for Post-stroke Gait Retraining: A Review of Current Evidence and Future Research Directions in the Context of Emerging Technologies. Spencer, J., Wolf, SL., Kesar, TM.[2021]

In a study involving 9 post-stroke individuals, both unilateral TLA and AGRF biofeedback significantly improved gait biomechanics by increasing anteriorly-directed ground reaction forces (AGRF) and trailing limb angle (TLA) on the paretic limb.

TLA biofeedback was particularly effective, leading to larger increases in TLA compared to AGRF biofeedback, suggesting that TLA could be a valuable target for gait rehabilitation in post-stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate improvements in post-stroke gait biomechanics are induced with both real-time limb position and propulsive force biofeedback. Santucci, V., Alam, Z., Liu, J., et al.[2023]

Training in a virtual reality (VR) environment with visual and audio biofeedback can effectively induce temporary asymmetrical gait patterns in healthy young adults, as shown by significant changes in step length after just 23 minutes of walking.

The study suggests that this VR biofeedback method could be a promising new approach for treating conditions like hemiplegic gait, as the induced asymmetries in walking persisted even after returning to a real environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground gait training using virtual reality aimed at gait symmetry. Shideler, BL., Martelli, D., Prado, A., et al.[2021]

Gait training on a treadmill significantly improved walking parameters and functional capacity in 50 stroke patients at least 6 months post-stroke, with both training methods showing positive results.

Using visual biofeedback during treadmill training led to greater improvements in specific gait metrics, such as stance phase shortening and swing phase lengthening, compared to treadmill training without biofeedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of gait training using a treadmill with and without visual biofeedback in patients after stroke: A randomized study. Drużbicki, M., Guzik, A., Przysada, G., et al.[2022]

Citations

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