50 Participants Needed

Electrical Stimulation and Gait Training for Improved Walking

TK
Overseen ByTrisha Kesar, PT, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Electrical Stimulation and Gait Training for Improved Walking?

Research shows that combining functional electrical stimulation (FES) with gait training can improve walking ability in people recovering from a stroke. Studies found that using an electromechanical gait trainer with FES led to better outcomes compared to conventional gait training alone, indicating that FES adds benefits to walking therapy.12345

How is the Gait Training treatment different from other treatments for improving walking?

Gait Training with electrical stimulation is unique because it uses electrical impulses to stimulate muscle contractions and coordinated movements, which helps restore more natural walking patterns that are difficult to achieve with voluntary effort alone. This approach can be more effective than traditional gait training, especially when combined with technologies like electromechanical gait trainers or body weight-supported treadmill training.12678

What is the purpose of this trial?

This study is being done to answer the question: What are the effects of electrical stimulation and stepping practice on connections between the brain and muscles? The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols founded on an understanding of neurobiological mechanisms that combine electrical stimulation with gait training to improve gait performance in older adults and stroke survivors.The rationale of this project is to explore and generate preliminary data regarding how electrical stimulation-based strategies modulate cortical and spinal circuits in able-bodied individuals.The researchers will evaluate the effects of short treadmill walking bouts or single gait training sessions with and without electrical stimulation on somatosensory, spinal-reflex, corticospinal circuit neurophysiology, and/or gait performance.The study will provide important preliminary and normative data that can explain how brain circuits change with stimulation or stepping practice and inform future rehabilitation studies on patients. The study population is able-bodied individuals.

Research Team

TK

Trisha Kesar, PT, PhD

Principal Investigator

Emory University

Eligibility Criteria

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
See 10 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Paired stimulation of the cortex and peripheral nervous systemExperimental Treatment2 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 stimulationExperimental Treatment1 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 stimulationExperimental Treatment2 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Findings from Research

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

References

Efficacy of an Electromechanical Gait Trainer Poststroke in Singapore: A Randomized Controlled Trial. [2018]
Effectiveness of gait training using an electromechanical gait trainer, with and without functional electric stimulation, in subacute stroke: a randomized controlled trial. [2022]
Gait training of patients after stroke using an electromechanical gait trainer combined with simultaneous functional electrical stimulation. [2016]
Development and testing of the Gait Assessment and Intervention Tool (G.A.I.T.): a measure of coordinated gait components. [2022]
Robotic orthoses for body weight-supported treadmill training. [2007]
Response of gait deficits to neuromuscular electrical stimulation for stroke survivors. [2007]
Orthotic and therapeutic effect of functional electrical stimulation on fatigue induced gait patterns in people with multiple sclerosis. [2018]
Effect of functional electrical stimulation plus body weight-supported treadmill training for gait rehabilitation in patients with poststroke: a retrospective case-matched study. [2020]
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