What is this study trying to find out about foot drop after stroke?

This study is investigating whether combining two types of electrical stimulation, transcranial direct current stimulation (tDCS) and functional electrical stimulation (FES), can improve foot drop in people after stroke. Researchers want to see if this combined treatment improves toe lifting and walking ability. The study is led by Saint Joseph's University in Philadelphia.

Who may be eligible for this foot drop clinical trial?

Adults aged 18 or older who have had one or more strokes affecting ankle movement more than 6 months ago may be eligible. Participants should be able to walk independently for at least 15 minutes without using an ankle-foot orthosis and must understand simple instructions. Please review eligibility criteria for more details.

Is there any cost to participate in this foot drop clinical trial?

Study-related care, including the electrical stimulation treatments and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07592221

Study of Combined Electrical Stimulation Treatments to Improve Foot Drop in Adults After Stroke

Led by Saint Joseph's University, Philadelphia · Updated on 2026-05-18

Participants Needed

Research Sites

34 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether combining transcranial direct current stimulation tDCS and functional electrical stimulation FES can better help people who have difficulty lifting their toes after a stroke. This study focuses on individuals who have had one or more strokes affecting ankle dorsiflexion and aims to see if this combined approach can reduce foot drop by improving toe clearance and ankle movement during walking. Participants receive tDCS through electrodes placed on the scalp targeting the motor cortex region linked to the affected leg, delivering a one milliamp current for 60 minutes during gait training twice weekly for eight weeks. FES is applied to the tibialis anterior muscle of the impaired leg using electrodes placed over the common peroneal nerve and muscle belly. During sessions, participants also perform leg strengthening exercises including treadmill training with forward and backward walking, obstacle navigation, ramp, and stair ambulation. Before treatment starts, assessments of toe clearance and gait speed are done 2-3 days prior, with follow-up tests 2-3 days after completing 12 sessions over 6-8 weeks. Additional measures include functional gait and balance scales. Vitals and heart rate are monitored during each session, along with perceived exertion ratings. Participants are followed through the treatment period to evaluate improvements and safety.

CONDITIONS

Brief Title

Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	FES and Active tDCS	FES and Sub-threshold tDCS
What it is	A gait training program combining functional electrical stimulation (FES) for foot drop with active transcranial direct current stimulation (tDCS) over the motor cortex.	The same intensive gait training with FES for foot drop, but paired with sub-threshold (non-active) tDCS.
Role in trial	Tests whether adding active brain stimulation during FES-assisted training enhances walking recovery in people with post-stroke foot drop.	Acts as the active control arm, isolating effects of FES gait training without active (sham/sub-threshold) tDCS.
Primary use	Studied as a potential way to further improve foot clearance and walking speed for adults who have persistent foot drop after a stroke.	Serves as the comparator to help measure the added benefit, if any, of active tDCS in the same rehabilitation setting.
How it is given or performed	FES devices stimulate foot muscles during supervised treadmill and mobility training sessions, with simultaneous active tDCS applied over the motor region of the brain.	The same FES-augmented gait training is provided, but tDCS is administered at a sub-threshold (sham) intensity.
Evidence status	Clinical effectiveness of adding active tDCS to FES gait training in post-stroke foot drop is under investigation; results have not been established.	The benefit of FES training with sub-threshold tDCS for post-stroke foot drop is being directly compared in this trial.
Important limitations	The experimental protocol's benefit compared to FES with sub-threshold tDCS is unknown, and safety or longer-term effects are not yet established. The small sample size and absence of a usual care group may limit interpretation.	Long-term efficacy or generalizability of FES training with sham tDCS for foot drop after stroke is not yet established. Results may not reflect current standard rehabilitation in all settings.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

18 years or older
Have had one or more strokes more than 6 months ago affecting ankle dorsiflexion
Discharged from all rehabilitative services
Able to walk independently with or without an assistive device such as a cane but without an ankle-foot orthosis (AFO) for at least 15 minutes

You will not qualify if you...

Unable to understand or repeat two-step commands
Have peripheral neuropathy
History of skull or scalp damage such as fracture
History of seizures or epilepsy
Extremely high or low blood pressure or heart rate
Experience chest pain or shortness of breath at rest
Received Botox injections to the leg or foot within the last 4 months

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive combined functional electrical stimulation (FES) and transcranial direct current stimulation (tDCS) paired with gait training involving treadmill, obstacle, ramp, and stair ambulation to improve foot drop.

Twice weekly visits for 8 weeks

Follow-up

Duration - 2 to 3 days

Participants undergo assessments including minimum toe clearance, gait speed, functional gait, and balance 2-3 days after the final treatment session to evaluate the effects of the intervention.

1 visit (in-person)