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

Trial Summary

What is the purpose of this trial?

The study seeks to develop an understanding of how, why, and for whom fast treadmill walking (Fast) and Fast with functional electrical stimulation (FastFES) induce clinical benefits, allowing future development of cutting-edge, individually-tailored gait treatments that enhance both gait quality and gait function.

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 Fast Treadmill Walking with Functional Electrical Stimulation (FES) for post-stroke gait improvement?

Research shows that combining fast treadmill walking with functional electrical stimulation (FES) can improve walking ability in stroke survivors by enhancing aspects like ground reaction force and knee movement. This combination therapy has been found to reduce the energy cost of walking and increase walking distance, making it a promising rehabilitation method for improving gait after a stroke. ^{1 2 3 4 5}

Is the combination of treadmill training and functional electrical stimulation (FES) safe for humans?

The studies reviewed do not report any specific safety concerns related to the combination of treadmill training and functional electrical stimulation (FES) for post-stroke gait rehabilitation, suggesting it is generally safe for human use. ^{1 2 3 4 6}

How does the treatment Fast Treadmill Walking with Functional Electrical Stimulation (FES) differ from other treatments for post-stroke gait improvement?

This treatment is unique because it combines fast treadmill walking with functional electrical stimulation (FES), which targets specific muscles to improve walking ability. The combination of faster walking speeds and FES has shown to enhance multiple aspects of gait, such as ground reaction force and limb movement, more effectively than slower speeds or FES alone. ^{1 3 4 5 7}

Research Team

Trisha Kesar, PT, PhD

Principal Investigator

Emory University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Switzerland 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. [2022]

2. United States 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. [2018]

3. Italy 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Combined effects of fast treadmill walking and functional electrical stimulation on post-stroke gait. [2021]

5. Netherlands 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. [2022]

6. Sweden pubmed.ncbi.nlm.nih.gov

Restoration of gait by combined treadmill training and multichannel electrical stimulation in non-ambulatory hemiparetic patients. [2006]

7. Brazil 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. [2019]