Implant for Walking After Stroke

This study is testing if an implanted device can help improve walking for people who have had a stroke. The devices, called IRS-8, IST 12, or IST 16, are surgically placed to send electrical signals to muscles involved in walking. Researchers will measure your walking speed before the implant, and again about 18 weeks and 44 weeks after the implant, to see if it helps. You might be able to join if you are 21-75 years old, had a stroke at least six months ago, can walk with some help, and walk slower than 0.8 meters per second. The study is currently recruiting a small number of participants.

Study design: This is an interventional study that plans to enroll 6 participants. It is a device study, not a drug study.
What's involved: You would undergo screening, surgery to implant the device, training to use it at home, and follow-up evaluations over several months.
Compensation: Not stated in the trial record.
Follow-up: Your walking speed will be measured at baseline, about 18 weeks after the implant, and about 44 weeks after the implant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Implant for Walking After Stroke

Active, Not Recruiting

NAAges 21–75InterventionalDevice feasibility

MetroHealth Medical Center

~6 participants

Updated 2026-08-21 on ClinicalTrials.gov

What's tested:IRS-8IST 12 & IST 16

At a glance

Recruiting sites

0 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Difference in Gait speed

Measured over baseline, ~18 weeks post implant, ~44 week post implant

Conditions

Stroke

Hemiplegia

Gait, Hemiplegic

NCT05740540

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohiono site contact published
MetroHealth Medical Center
Cleveland, Ohiono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Nathan Makowski, PhD · PRINCIPAL_INVESTIGATOR · MetroHealth System, Ohio

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

At least 6-months post stroke

Age 21 to 75 years old

Able to ambulate, but does not require the assistance of more than one person

Walk slower than 0.8m/s during a 10m walk test

Lower extremity Fugl-Meyer Motor Assessment (FMA) \<= 20

Reduced peak hip, knee and/or ankle range of motion during stance or swing phases

Modified Ashworth Scale (MAS) \<= 2 at the above joints during passive flexion and extension

Innervated and excitable lower extremity and trunk musculature

Appropriate body habitus (height and weight within acceptable limits as determined by study physician)

Adequate social support and stability

Willingness to comply with follow-up procedures

Neurologically stable as determined by a physician

Exclusion

Non-English speaking

Significant range of motion limitations (lacking hip extension, etc.)

History of spontaneous fractures or other evidence of excessively low bone density

Acute orthopedic problems (severe scoliosis, joint dislocations, etc.)

Medical complications (cardiac abnormalities, skin breakdowns, uncontrolled seizures, immunological/pulmonary/renal/circulatory compromise, additional neurologic conditions etc.)

Cardiovascular or pulmonary disease

Uncontrolled diabetes or hypertension

Presence of a demand pacemaker or cardiac defibrillator

Pregnancy

Complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.)

Significant history of repeated falls

Severely impaired cognition and communication

Any other medical or psychological condition that would be a contraindication

What this trial measures

Difference in Gait speedbaseline, ~18 weeks post implant, ~44 week post implant
The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance. Gait speed is how we're evaluating whether the advanced controller works better than a simple generic triggering approach.

Trialytics