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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this project is to determine the feasibility and optimal parameters of a novel, comprehensive approach to gait training in individuals with chronic stroke. The comprehensive approach includes biofeedback-based gait training and aerobic exercise intensity-based gait training.

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.

Is biofeedback-based gait training safe for humans?

The research on biofeedback-based gait training, including methods like step-length biofeedback and real-time limb position feedback, suggests it is generally safe for humans. Studies have shown it can improve walking patterns in individuals with post-stroke conditions without reporting any significant safety concerns. ^{1 2 3 4 5}

How is the Comprehensive Gait Rehabilitation treatment for post-stroke recovery different from other treatments?

This treatment is unique because it combines aerobic exercise with biofeedback, which provides real-time sensory feedback to help improve walking patterns. The use of biofeedback, including step length and propulsive force feedback, helps patients correct gait asymmetries and improve walking function, making it a promising approach for post-stroke rehabilitation. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Comprehensive Gait Rehabilitation for Post-Stroke Recovery?

Research shows that biofeedback, which provides real-time sensory feedback, can improve walking patterns in people recovering from a stroke. Studies have found that using biofeedback during gait training can help correct walking asymmetries and increase the strength of the weaker leg, making it a promising approach for post-stroke rehabilitation. ^{2 3 6 7 8}

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.

Participants enrolled in Aim 2 will require medical clearance from physician to participate

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

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]

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]

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]

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]

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]

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

The Short-Term Effects of Rhythmic Vibrotactile and Auditory Biofeedback on the Gait of Individuals After Weight-Induced Asymmetry. [2023]

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

Step-length biofeedback device for walk rehabilitation. [2019]

3. Switzerland 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. [2021]

4. Sweden pubmed.ncbi.nlm.nih.gov

Efficacy of gait training using a treadmill with and without visual biofeedback in patients after stroke: A randomized study. [2022]

5. Germany 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Immediate improvements in post-stroke gait biomechanics are induced with both real-time limb position and propulsive force biofeedback. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Overground gait training using virtual reality aimed at gait symmetry. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Effects of unilateral real-time biofeedback on propulsive forces during gait. [2019]