Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait

DEVICE

Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES)

The model-predictive controller (MPC) determines the timing and intensity of electrical stimulation delivered for FES. MPC combined with real-time ultrasound-based feedback delivers optimal FES intensities and minimizes fatigue. FES is delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.

DEVICE

Conventional Functional Electrical Stimulation (FES)

For functional electrical stimulation, surface electrodes are placed on the paretic leg on skin overlying the tibialis anterior (TA) muscle, with intensity pre-set to elicit dorsiflexion to neutral against gravity. FES will be delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.

Number of Adverse Events

Time frame: Day 1

Safety is assessed as the number of adverse events experienced by study participants.

Count of Risks

Time frame: Day 1

Safety is assessed as the count of risks, including falling, discomfort, pain, skin problems, fatigue, and soreness.

Participant Perception of Comfort

Time frame: Day 1

Participant perception of comfort is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most comfortable.

Participant Perception of Acceptability

Time frame: Day 1

Participant perception of acceptability is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most acceptable.

Percent of Gait Cycles with Footdrop Correction

Time frame: Day 1

Feasibility of the FES control system is assessed as the percentage of gait cycles with footdrop correction. The FES control system is considered effective if greater than 80% of gait cycles have footdrop correction.

Number of Participants Completing Gait Bouts

Time frame: Day 1

Feasibility of the FES control system is assessed as the number of participants who are able to complete gait bouts with the MPC FES system. The FES control system is considered effective if greater than 80% of participants are able to complete gait bouts.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.