Electrical Stimulation and Gait Training for Improved Walking

Overseen By Trisha Kesar, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Cortical excitability meds

Disqualifiers: Neurological, Orthopedic, Hypertension, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2-8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical stimulation combined with walking exercises can enhance the brain-muscle connection. The researchers aim to develop new rehabilitation methods to help older adults and stroke survivors improve their walking abilities. Participants will engage in various walking sessions, some with electrical stimulation (such as Functional Electrical Stimulation, or FES) and some without, to assess their effects on walking and brain circuits. The study seeks healthy individuals who can walk on a treadmill for at least one minute without any physical disabilities. As an unphased trial, it offers participants the chance to contribute to innovative rehabilitation research that could benefit many in the future.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medications that can increase cortical excitability, you may not be eligible to participate.

What prior data suggests that these protocols are safe?

In earlier studies, electrical stimulation methods like paired associative stimulation (PAS) have shown promising results. Specifically, research shows that just one session of this technique can greatly increase muscle strength in stroke patients. This suggests that the treatment is generally well-tolerated, with no major safety issues reported.

Regarding gait training with functional electrical stimulation (FES), studies have found it both practical and safe. Participants did not experience any serious negative effects. This method has also improved walking speed and recovery in stroke survivors.

Overall, these findings suggest that both PAS and FES are safe for use in people, with minimal risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for improving walking because they explore new ways to stimulate the nervous system. Unlike traditional physical therapy for gait training, which relies on repetitive movement exercises, these treatments use electrical stimulation to enhance neural connections. One approach combines cortical and peripheral stimulation to potentially boost brain and nerve communication, which could lead to more effective rehabilitation. Another method incorporates functional electrical stimulation during treadmill walking, aiming to directly influence neural circuit excitability and potentially speed up recovery. These innovative techniques might offer quicker and more substantial improvements in walking ability compared to standard gait training methods.

What evidence suggests that this trial's treatments could be effective for improving gait performance?

Research has shown that using electrical stimulation with brain signals can strengthen muscles in stroke patients. One study demonstrated that just one session of this stimulation increased muscle strength and voluntary movement. In this trial, participants will receive either peripheral electrical stimulation paired with cortical stimulation pulses or gait training with or without functional electrical stimulation (FES). When combined with walking exercises, known as gait training, FES has improved walking ability, balance, and endurance in stroke survivors. Another study found that people who did FES gait training walked faster and recovered better. These findings suggest that electrical stimulation, whether used with brain signals or during walking exercises, may improve walking and muscle function. ^{6 7 8 9 10}

Who Is on the Research Team?

Trisha Kesar, PT, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for able-bodied individuals aged 18-65 who can walk and follow commands. They must not have any physical disabilities, neurological disorders, or medical conditions that affect walking or participation in the study protocol.

Inclusion Criteria

I can walk more than 10 meters and use a treadmill for at least 1 minute.

I can understand and follow detailed instructions.

I am healthy and can walk without assistance.

Exclusion Criteria

Pregnancy (female)

I have a history of brain or nerve problems.

Bruises or cuts at the stimulation electrode placement site

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo gait training with or without electrical stimulation over 2-8 weeks, including multiple walking bouts and non-invasive measurements.

2-8 weeks

2 to 5 visits (in-person)

Follow-up

Participants are monitored for changes in neurophysiology and gait performance after treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Functional electrical stimulation (FES)
• Gait Training
• Peripheral electrical stimulation paired with cortical stimulation pulses

Trial Overview The study tests how electrical stimulation combined with gait training affects brain-muscle connections. It involves treadmill walking and single gait training sessions with various types of electrical stimulation to improve gait performance.

How Is the Trial Designed?

Group I: Paired stimulation of the cortex and peripheral nervous system Experimental Treatment 2 Interventions

Participants will participate in a single session of peripheral electrical stimulation paired with cortical stimulation pulses (i.e. paired associative stimulation(PAS)) on somatosensory, spinal-reflex, and corticospinal neurophysiology.

Group II: Gait without functional electrical stimulation Experimental Treatment 1 Intervention

Participants will participate in 2 to 5 sessions over 2-8 weeks. Each session will comprise gait or stepping practice on a treadmill without functional electrical stimulation, and non-invasive measurement of neural circuit excitability. Participants will complete multiple 30-second to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts. For gait training, participants may complete up to six 6-minute bouts of walking with rest breaks between bouts (30-36 minutes walking).

Group III: Gait with functional electrical stimulation Experimental Treatment 2 Interventions

Participants will participate in 2 to 5 sessions over 2-8 weeks. Each session will comprise gait or stepping practice on a treadmill with functional electrical stimulation, and non-invasive measurement of neural circuit excitability. Participants will complete multiple 30-second to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts. For gait training, participants may complete up to six 6-minute bouts of walking with rest breaks between bouts (30-36 minutes walking).

Gait Training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Gait Training for:

• Spinal Cord Injury
• Cerebral Palsy
• Stroke Rehabilitation

Approved in European Union as Gait Training for:

• Spinal Cord Injury
• Neurological Rehabilitation

Approved in Canada as Gait Training for:

• Spinal Cord Injury
• Stroke Rehabilitation

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Neuromuscular electrical stimulation (NMES) can significantly improve gait coordination in stroke survivors by inducing muscle contractions that help restore normal movement patterns, which are often impaired after a stroke.

Training with implanted NMES systems is more effective than traditional gait training without stimulation, as it enhances volitional coordinated gait components, leading to better overall mobility and reduced risk of falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response of gait deficits to neuromuscular electrical stimulation for stroke survivors. Daly, JJ.[2007]

Prolonged use of functional electrical stimulation (FES) for 8 weeks can improve gait patterns in people with Multiple Sclerosis (MS), particularly by enhancing walking speed and neuromuscular control, even after fatigue.

While FES alone does not completely counteract fatigue-related gait deficits, it can positively affect lower limb mechanics, especially in generating power during push-off, suggesting its potential as both a gait retraining and orthotic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthotic and therapeutic effect of functional electrical stimulation on fatigue induced gait patterns in people with multiple sclerosis. Barr, CJ., Patritti, BL., Bowes, R., et al.[2018]

A study involving 180 poststroke patients found that combining functional electrical stimulation (FES) with body weight-supported treadmill training (BWSTT) significantly improved gait, balance, and lower limb function compared to BWSTT alone.

The FES plus BWSTT group showed enhanced nerve conduction and evoked potential responses, indicating a positive effect on neural recovery, with no adverse events reported during the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of functional electrical stimulation plus body weight-supported treadmill training for gait rehabilitation in patients with poststroke: a retrospective case-matched study. Bao, X., Luo, JN., Shao, YC., et al.[2020]

The use of an electromechanical gait trainer combined with functional electrical stimulation (FES) in a 4-week program led to significant improvements in gait performance and functional activities for two patients with acute ischemic stroke.

Both patients maintained their improvements in various measures of mobility and balance, such as the Barthel Index and Berg Balance Scale, even 6 months after the intervention, indicating long-term benefits of this rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training of patients after stroke using an electromechanical gait trainer combined with simultaneous functional electrical stimulation. Tong, RK., Ng, MF., Li, LS., et al.[2016]

The Gait Assessment and Intervention Tool (G.A.I.T.) is a newly developed 31-item measure that effectively assesses and scores improvements in gait coordination after stroke, demonstrating high reliability (ICC values of .98 and .83) and the ability to detect treatment responses.

The G.A.I.T. was able to differentiate between the effectiveness of two gait training interventions, showing that adding functional electrical stimulation (FES) to comprehensive gait training provided additional benefits for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of the Gait Assessment and Intervention Tool (G.A.I.T.): a measure of coordinated gait components. Daly, JJ., Nethery, J., McCabe, JP., et al.[2022]

Robotic devices for assisted stepping in gait rehabilitation can significantly reduce the physical effort required from therapists while increasing the amount of practice patients receive, making therapy more efficient.

Current clinical studies show promising results for these robotic devices in improving locomotor rehabilitation for patients with neurological impairments, such as those recovering from stroke or spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic orthoses for body weight-supported treadmill training. Winchester, P., Querry, R.[2007]

In a study involving 50 patients with subacute stroke, those who underwent gait training using an electromechanical gait trainer (EGT) or EGT with functional electric stimulation (EGT-FES) showed significantly greater improvements in walking speed and mobility compared to those receiving conventional gait training (CGT).

Both EGT and EGT-FES resulted in better outcomes in various mobility assessments, indicating that these advanced training methods may enhance rehabilitation effectiveness for stroke patients, with no significant difference between the EGT and EGT-FES groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of gait training using an electromechanical gait trainer, with and without functional electric stimulation, in subacute stroke: a randomized controlled trial. Tong, RK., Ng, MF., Li, LS.[2022]

In a study involving 106 nonambulant individuals with subacute stroke, the combination of electromechanical gait trainers (GTs) and conventional physiotherapy did not show significant advantages over conventional physiotherapy alone in improving ambulation and health status.

Both treatment groups demonstrated improvements in functional ambulation, health status, and participation over time, indicating that while GTs are beneficial, they may not provide additional benefits compared to standard physiotherapy for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an Electromechanical Gait Trainer Poststroke in Singapore: A Randomized Controlled Trial. Chua, J., Culpan, J., Menon, E.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10178257/

Gait Training with Functional Electrical Stimulation Improves ... Gait training with FES improved mobility, balance, non-paretic limb coordination, and endurance in post-stroke patients, especially when ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21401663/

Effects of fast functional electrical stimulation gait training on ... FastFES gait training increased mechanical recovery from 34.5% to 40.0% and walking speed from 0.4 m/s to 0.7 m/s after 12 weeks.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1013702514000451

Therapeutic effects of functional electrical stimulation on ... The purpose of this parallel group controlled clinical trial was to investigate the therapeutic effect of functional electrical stimulation (FES) on gait, ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2018.01127/full

Gait Rehabilitation Using Functional Electrical Stimulation ... The aim of this study was to investigate three cases illustrating how FastFES modulates ankle muscle recruitment during walking.

5. nature.com nature.com/articles/3101595

Electromechanical gait training with functional electrical ... This combined technique allows intensive locomotor therapy in SCI subjects with reduced effort from the therapists.

6. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/42638/50370

Feasibility and safety of automated multi-channel FES ... The study found automated multi-channel FES-assisted gait training was feasible and safe, with no serious adverse events, and most participants ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12128624/

FEASIBILITY AND SAFETY OF AUTOMATED MULTI ... The study found automated FES-assisted gait training was feasible and safe, with no serious adverse events, and most participants showed improved gait.

8. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/42638

Feasibility and safety of automated multi-channel FES ... The study found automated FES-assisted gait training was feasible and safe, with most participants showing improved gait, though individual ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3081781/

Effects of Fast Functional Electrical Stimulation Gait ... This study demonstrated that FastFES training has the capacity to increase the gait speed and improve the mechanical recovery of stroke survivors when they ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04568928

Powered Exoskeleton Combined With Functional Electrical ... The goal of this project is to bring together researchers, administrators, clinicians and patients to define and implement an overground robotized gait training ...