StrokeNCT05740540
Implant for Walking After Stroke
A study testing IRS-8 and IST 12 & IST 16 in people with Stroke and Hemiplegia, run by MetroHealth Medical Center at 2 sites in United States.
Trial summary
This is a device study that will evaluate the effect of an implanted stimulator on improving walking in stroke survivors. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Stroke, Hemiplegia, Gait, Hemiplegic
- What is being tested?
- IRS-8 and IST 12 & IST 16
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 May 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
About this study
Official title: Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke
This is a device study that will evaluate the effect of an implanted stimulator on improving walking in stroke survivors. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.
Read the detailed description
The purpose of this study is to evaluate the effects of neural stimulation for improving walking after stroke. Participants will undergo surgery to implant a stimulator and electrodes to activate muscles used during walking. The device delivers electrical pulses to the nerves causing the muscles to contract to perform functional movements. The system coordinates assistance based on external sensors. After receiving the implanted device, participants undergo training to use the device to assist walking. Evaluations are completed prior to surgery as well after training and at later follow up sessions.
- Conditions
- Stroke, Hemiplegia, Gait, Hemiplegic
- Being tested
- IRS-8, IST 12 & IST 16
- Medical subject headings
- Stroke, Hemiplegia, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRS-8Device
Implanted Receiver Stimulator (IRS) delivering 8 channels of stimulation. Appropriate for muscle-based (intramuscular or epimysial) electrodes only
IST 12 & IST 16Device
Implantable Stimulator Telemeter (IST) that provides 12 independent channels of stimulation with the option of 2 channels of bipolar myoelectric signal recording, or 16 independent stimulus channels. Suitable for muscle-based or nerve cuff electrodes such as the CWRU Spiral, Flat Interface Nerve Electrode (FINE) or Composite-Flat Interface Nerve Electrode (C-FINE).
| Study group | Role | What they receive |
|---|---|---|
| Implantation, controller development, and evaluation | Experimental | This phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months. Receives: Device: IRS-8; Device: IST 12 & IST 16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Gait speed
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.
Measured: baseline, ~18 weeks post implant, ~44 week post implant
Secondary outcomes (1)
Difference in Usability Rating Scale (URS)
participants will rate the task on a seven-point scale from "very easy" (3) to "very difficult" (-3). Difficulty will be assessed after the 10 m walk test
Measured: baseline, ~18 weeks post implant, ~44-week post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start16 May 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Louis Stokes VA Medical Center, Cleveland State University
- Responsible party
- Principal investigator, Nathaniel Makowski, MetroHealth Medical Center
- Investigators
- Nathan Makowski, PhD, Principal investigator, MetroHealth System, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740540
- Sponsor's protocol ID
- StudyID00000125
- Status last verified
- Sep 2025
- First submitted
- 18 Jan 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified assessment data will be shared via NICHD DASH
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke
- ClinicalTrials.gov ID
- NCT05740540
- Acronym / sponsor ID
- StudyID00000125
- Conditions
- Stroke, Hemiplegia, Gait, Hemiplegic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Louis Stokes VA Medical Center, Cleveland State University
- Study start
- 16 May 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a device study that will evaluate the effect of an implanted stimulator on improving walking in stroke survivors. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.
Detailed description
The purpose of this study is to evaluate the effects of neural stimulation for improving walking after stroke. Participants will undergo surgery to implant a stimulator and electrodes to activate muscles used during walking. The device delivers electrical pulses to the nerves causing the muscles to contract to perform functional movements. The system coordinates assistance based on external sensors. After receiving the implanted device, participants undergo training to use the device to assist walking. Evaluations are completed prior to surgery as well after training and at later follow up sessions.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation, controller development, and evaluation | Experimental | Device: IRS-8, Device: IST 12 & IST 16This phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRS-8Implanted Receiver Stimulator (IRS) delivering 8 channels of stimulation. Appropriate for muscle-based (intramuscular or epimysial) electrodes only | Device | Implantation, controller development, and evaluation |
| IST 12 & IST 16Implantable Stimulator Telemeter (IST) that provides 12 independent channels of stimulation with the option of 2 channels of bipolar myoelectric signal recording, or 16 independent stimulus channels. Suitable for muscle-based or nerve cuff electrodes such as the CWRU Spiral, Flat Interface Nerve Electrode (FINE) or Composite-Flat Interface Nerve Electrode (C-FINE). | Device | Implantation, controller development, and evaluation |
Primary outcome
Difference in Gait speed
Time frame: baseline, ~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.
1 secondary outcome
Difference in Usability Rating Scale (URS)
Time frame: baseline, ~18 weeks post implant, ~44-week post implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified assessment data will be shared via NICHD DASH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Makowski, PhD principal investigator
MetroHealth System, Ohio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRS-8 and IST 12 & IST 16 in people with Stroke and Hemiplegia, run by MetroHealth Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Gait speed (time frame: baseline, ~18 weeks post implant, ~44 week post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.