FES + Treadmill Training for Post-Stroke Gait Improvement

Overseen By Trisha Kesar, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Hemorrhagic stroke, Ataxic gait, others

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

Compensation: Varies

Number of Visits: 16

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve walking abilities in people who have had a stroke by using two types of treadmill training. One group will walk on a treadmill with functional electrical stimulation (FES), which sends small electrical pulses to enhance movement in the affected ankle. The other group will walk on the treadmill without these electrical pulses. The study seeks participants who had a stroke over six months ago, can walk at least 10 meters with or without assistance, and have stable ankles for treadmill walking. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance rehabilitation methods for stroke survivors.

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 protocol is safe for post-stroke gait improvement?

Research shows that walking quickly on a treadmill can safely enhance walking abilities after a stroke. Studies have found that it significantly increases walking speed and endurance. Most participants handle it well, with no major safety issues reported.

Similarly, combining treadmill walking with functional electrical stimulation (FES) also appears safe. FES uses gentle electrical pulses to improve muscle movement. Evidence suggests that this combination enhances balance and coordination more effectively than treadmill walking alone. Previous studies have not reported any serious side effects, indicating it is well-tolerated by participants.

Both treatments, fast treadmill walking and FastFES, have demonstrated promising safety records. No significant safety issues have been reported, making them viable options for those seeking to improve recovery after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments in this trial because they explore how combining treadmill walking with Functional Electrical Stimulation (FES) can enhance recovery for stroke survivors. Unlike traditional physical therapy, which often focuses on general movement improvement, FastFES specifically targets the paretic ankle muscles. This method uses electrical stimulation to boost muscle activation and improve ankle propulsion, potentially offering more precise and effective rehabilitation by enhancing the communication between the brain and muscles. By increasing corticomotor drive, researchers hope this approach will lead to better and faster improvements in walking for those affected by post-stroke hemiparesis.

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

Research has shown that walking quickly on a treadmill with electrical stimulation, known as FastFES, can help stroke survivors walk better. Studies have found that FastFES improves balance, coordination, and stamina by stimulating the ankle muscles, enhancing muscle movement and walking strength. Participants using FastFES have reported better mobility and walking quality. In this trial, some participants will receive FastFES.

Others will engage in fast treadmill walking without electrical stimulation, which also offers benefits. This method can increase walking speed and stamina for stroke survivors, though it might not improve balance as much. Both methods show promise for improving walking after a stroke, with FastFES providing the added advantage of targeting specific muscles. ^{1 2 6 7 8}

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 individuals who've had a single ischemic stroke at least 6 months ago, can walk 10 meters with or without help, and have stable cardiovascular health. They must be able to use a treadmill without an orthosis and have a resting heart rate of 40-100 bpm. People with hemorrhagic stroke, severe coordination issues, certain NIH Stroke Scale scores, inability to communicate with researchers, conditions affecting walking ability other than stroke, lack of sensation in the affected limb or medical issues preventing trial completion are excluded.

Inclusion Criteria

I have had one stroke affecting the surface or deep parts of my brain.

It has been over 6 months since my stroke.

I can walk 10 meters with or without help.

Exclusion Criteria

I have difficulty walking steadily or coordinating my movements quickly.

I cannot feel my leg that was affected by a stroke.

Any medical diagnosis that would hinder the participant from completing the experimental trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Gait biomechanics, energy cost, corticospinal excitability, and gait function are evaluated

1 week

2 visits (in-person)

Treatment

Participants undergo 12 sessions of either Fast or FastFES treadmill walking interventions

4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fast Treadmill Walking
• Fast Treadmill Walking with Functional Electrical Stimulation (FES)
• Grass S8800 Stimulator with SIU8TB Stimulus Isolation Unit
• UDel Stimulator

Trial Overview The study is testing how fast treadmill walking alone (Fast) and combined with functional electrical stimulation (FastFES) can improve walking quality and function after a stroke. The goal is to understand these methods' biomechanical and neural effects better so that future treatments can be more personalized.

How Is the Trial Designed?

Group I: Fast treadmill walking with functional electrical stimulation (FastFES) Experimental Treatment 2 Interventions

Participants with post-stroke hemiparesis who are randomized to receive 12 sessions of FastFES. FastFES is a targeted intervention that provides motor level stimulation-induced cues to improve ankle propulsion. FES is delivered only to the paretic ankle muscles, enhancing afferent ascending as well as descending corticomotor drive. Increased corticomotor drive in lesioned corticomotor circuits in turn promotes improved timing and intensity of muscle activation in the paretic plantar- and dorsi-flexor muscles, increasing plantarflexor moment and propulsion from the paretic ankle.

Group II: Fast treadmill walking (Fast) Active Control 1 Intervention

Participants with post-stroke hemiparesis who are randomized to receive 12 sessions of Fast. Fast is a non-targeted intervention that provides similar structure, dose, and intensity of stepping practice as FastFES, but does not include FES, and no specific instructions are provided to target practice to the paretic leg or specific ankle deficits

Fast Treadmill Walking is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fast Treadmill Walking for:

• Post-stroke gait rehabilitation

Approved in European Union as Fast Walking Therapy for:

• Rehabilitation after stroke
• Gait disorders

Approved in Canada as Treadmill-Based Rehabilitation for:

• Stroke rehabilitation
• Gait training

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A meta-analysis of 14 studies involving 945 stroke patients found that body-weight-supported treadmill training (BWSTT) combined with functional electrical stimulation (FES) significantly improves various gait parameters compared to BWSTT alone.

The combination of BWSTT and FES showed better results in measures such as the 10 Meters Walking Test, gait speed, and balance assessments, indicating it is a more effective intervention for enhancing mobility in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The difference between the effectiveness of body-weight-supported treadmill training combined with functional electrical stimulation and sole body-weight-supported treadmill training for improving gait parameters in stroke patients: A systematic review and meta-analysis. Wang, J., Zhao, L., Gao, Y., et al.[2022]

In a study involving 12 individuals with chronic hemiparesis, the addition of functional electrical stimulation (FES) to treadmill gait training with partial body weight support (BWS) did not show any significant improvements in spatial-temporal gait parameters or motor function.

Despite the expectation that FES would enhance the effectiveness of gait training, the results indicated no additional benefits when compared to BWS training alone, suggesting that FES may not be necessary for improving gait in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the addition of functional electrical stimulation to ground level gait training with body weight support after chronic stroke. Prado-Medeiros, CL., Sousa, CO., Souza, AS., et al.[2019]

Combining functional electrical stimulation (FES) with treadmill walking at faster speeds significantly improves gait parameters in post-stroke individuals, as shown by enhanced peak anterior ground reaction force and knee flexion during walking.

Walking at the fastest speed with FES (FAST-FES) not only improves gait more than walking at self-selected speeds with FES (SS-FES) but also shows greater benefits compared to walking at the fastest speed without FES, indicating that FAST-FES could be a promising rehabilitation strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined effects of fast treadmill walking and functional electrical stimulation on post-stroke gait. Kesar, TM., Reisman, DS., Perumal, R., et al.[2021]

A study involving 50 participants more than 6 months post-stroke showed that combining fast walking with functional electrical stimulation (FastFES) significantly reduced the energy cost of walking (EC) by 24% at comfortable speeds and 19% at fast speeds, compared to traditional gait training methods.

While FastFES improved energy efficiency in walking, there were no significant differences in long-distance walking ability (measured by the 6-minute walk test) between the FastFES and other training groups, indicating that further research is needed to understand the relationship between energy cost and walking ability post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing The Cost of Transport and Increasing Walking Distance After Stroke: A Randomized Controlled Trial on Fast Locomotor Training Combined With Functional Electrical Stimulation. Awad, LN., Reisman, DS., Pohlig, RT., 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]

In a randomized controlled trial with 30 stroke survivors, treadmill training combined with tilt sensor functional electrical stimulation (TTSF) significantly improved balance and gait compared to a placebo group, as measured by the TUG, BBS, and 10 m walk test.

TTSF not only enhanced balance and gait but also positively affected the muscle architecture of the tibialis anterior in stroke survivors, indicating its potential as an effective rehabilitation intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training with tilt sensor functional electrical stimulation for improving balance, gait, and muscle architecture of tibialis anterior of survivors with chronic stroke: A randomized controlled trial. Hwang, DY., Lee, HJ., Lee, GC., et al.[2022]

A combined approach of functional electrical stimulation and treadmill training with partial body weight support led to significant improvements in gait ability for 11 chronic non-ambulatory hemiparetic patients within 3 to 6 weeks, as measured by the Functional Ambulation Category test.

In a detailed analysis of seven patients, this method showed better outcomes in gait restoration and walking velocity compared to standard physiotherapy, with statistically significant results (p < 0.05).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoration of gait by combined treadmill training and multichannel electrical stimulation in non-ambulatory hemiparetic patients. Hesse, S., Malezic, M., Schaffrin, A., et al.[2006]

Citations

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Effectiveness of Treadmill Training Intervention for the ... This meta‐analysis demonstrates significant improvements in walking speed (SMD = 0.255) and walking endurance (SMD = 0.277) in stroke survivors ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590113319300124

Effectiveness of treadmill assisted gait training in stroke ... Taken together, the results of this review suggested that treadmill training improves walking distance but not walking speed and balance after a stroke.

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COMBINED EFFECTS OF FAST TREADMILL WALKING ... Recent evidence suggests that treadmill walking at faster than self-selected speeds can help improve post-stroke gait impairments.

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8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1010790

Body-Weight–Supported Treadmill Rehabilitation after Stroke All groups had similar improvements in walking speed, motor recovery, balance, functional status, and quality of life. Neither the delay in ...