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Active, Not Recruiting

NCT Number: NCT05740540

Implant for Walking 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Gait, Hemiplegic Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, Ohio, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IRS-8

Device

Implanted Receiver Stimulator (IRS) delivering 8 channels of stimulation. Appropriate for muscle-based (intramuscular or epimysial) electrodes only

IST 12 & IST 16

Device

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Difference in Usability Rating Scale (URS)

    Time frame: baseline, ~18 weeks post implant, ~44-week post implant

    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

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Collaborators

  • Case Western Reserve University
  • Cleveland State University
  • Louis Stokes VA Medical Center

Registry information

Official study title

Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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