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Implanted stimulator aims to restore walking after stroke

NCT ID NCT05740540

Disease control Sponsor: MetroHealth Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests an implanted electrical stimulator to improve walking in people who have had a stroke. Six participants will first be screened, then receive the implant and use it at home. Researchers will compare advanced control settings to a simple trigger to see which works better for walking speed and ease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
implanted electrical stimulator device
What this could lead to
If it works, this could lead to a more natural and effective way for stroke survivors to walk again using an implanted device.
What could go wrong
This is a very small early-stage trial with only 6 participants, so results may not apply to everyone. The device requires surgery and may have risks like infection or device failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 6 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Gait Disorders, Neurologic hemiplegia stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gait, hemiplegic Hemiplegia Stroke

Contacts and locations

Locations

  • Louis Stokes Cleveland Veterans Affairs Medical Center

    Cleveland, Ohio, 44106, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

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