Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07592221

Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop: A Case Series

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

30

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

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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)

Trial Site Locations

Total: 1 location

1

Saint Joseph's University

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

G

Greg Thielman, EdD

S

Sylvester Carter, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A Scoping Review on Minimum Foot Clearance: An Exploration of Level-Ground Clearance in Individuals with Abnormal Gait.

Abdulrahman Al Bochi, Ghazaleh Delfi, Tilak Dutta

https://pubmed.ncbi.nlm.nih.gov/34639597