FES + Treadmill Training for Post-Stroke Gait Improvement

Recruiting in Palo Alto (17 mi)

Overseen by Trisha Kesar, PT, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Emory University

Disqualifiers: Hemorrhagic stroke, Ataxic gait, others

No Placebo Group

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}

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

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

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Emory University Hospital Atlanta, GA

Who Is Running the Clinical Trial?

Emory University Lead Sponsor

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

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] Body-weight-supported treadmill training (BWSTT) combined with functional electrical stimulation (FES) is considered an effective intervention method to improve gait parameters in stroke patients. In this article, we compared the effect of BWSTT combined with FES and BWSTT only on gait parameters in stroke patients.

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] Background Neurorehabilitation efforts have been limited in their ability to restore walking function after stroke. Recent work has demonstrated proof-of-concept for a functional electrical stimulation (FES)-based combination therapy designed to improve poststroke walking by targeting deficits in paretic propulsion. Objectives To determine the effects on the energy cost of walking (EC) and long-distance walking ability of locomotor training that combines fast walking with FES to the paretic ankle musculature (FastFES). Methods Fifty participants >6 months poststroke were randomized to 12 weeks of gait training at self-selected speeds (SS), fast speeds (Fast), or FastFES. Participants' 6-minute walk test (6MWT) distance and EC at comfortable (EC-CWS) and fast (EC-Fast) walking speeds were measured pretraining, posttraining, and at a 3-month follow-up. A reduction in EC-CWS, independent of changes in speed, was the primary outcome. Group differences in the number of 6MWT responders and moderation by baseline speed were also evaluated. Results When compared with SS and Fast, FastFES produced larger reductions in EC (Ps ≤.03). FastFES produced reductions of 24% and 19% in EC-CWS and EC-Fast (Ps

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] Functional electrical stimulation (FES) plus body weight-supported treadmill training (BWSTT) provide effective gait training for poststroke patients with abnormal gait. These features promote a successful active motor relearning of ambulation in stroke survivors.

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

Combined effects of fast treadmill walking and functional electrical stimulation on post-stroke gait. [2021] Gait dysfunctions are highly prevalent in individuals post-stroke and affect multiple lower extremity joints. Recent evidence suggests that treadmill walking at faster than self-selected speeds can help improve post-stroke gait impairments. Also, the combination of functional electrical stimulation (FES) and treadmill training has emerged as a promising post-stroke gait rehabilitation intervention. However, the differential effects of combining FES with treadmill walking at the fast versus a slower, self-selected speed have not been compared previously. In this study, we compared the immediate effects on gait while post-stroke individuals walked on a treadmill at their self-selected speed without FES (SS), at the SS speed with FES (SS-FES), at the fastest speed they are capable of attaining (FAST), and at the FAST speed with FES (FAST-FES). During SS-FES and FAST-FES, FES was delivered to paretic ankle plantarflexors during terminal stance and to paretic dorsiflexors during swing phase. Our results showed improvements in peak anterior ground reaction force (AGRF) and trailing limb angle during walking at FAST versus SS. FAST-FES versus SS-FES resulted in greater peak AGRF, trailing limb angle, and swing phase knee flexion. FAST-FES resulted in further increase in peak AGRF compared to FAST. We posit that the enhancement of multiple aspects of post-stroke gait during FAST-FES suggest that FAST-FES may have potential as a post-stroke gait rehabilitation intervention.

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] Gait training is important for stroke rehabilitation, such as using the treadmill training with functional electrical stimulation (FES).

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

Restoration of gait by combined treadmill training and multichannel electrical stimulation in non-ambulatory hemiparetic patients. [2006] Functional electrical stimulation and treadmill training with partial body weight support through suspension by a parachute harness were combined for gait restoration in 11 chronic non-ambulatory hemiparetic patients. Individually adjusted multichannel stimulation of the trunk and of upper and lower limb muscles, as well as a motor driven treadmill, induced functional gait within 3 to 6 weeks. The improvement of gait ability was assessed by the Functional Ambulation Category test. Other motor functions were rated by the Rivermead Motor Score. The leg muscle strength, stride length, cadence, gait velocity and gait pattern were recorded. In seven of the patients, we did a single case research A-B-A study that showed that this combined approach had advantages, in regard to gait restoration and walking velocity (p

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] The addition of functional electrical stimulation (FES) to treadmill gait training with partial body weight support (BWS) has been proposed as a strategy to facilitate gait training in people with hemiparesis. However, there is a lack of studies that evaluate the effectiveness of FES addition on ground level gait training with BWS, which is the most common locomotion surface.