Implant for Walking After Stroke

June 27, 2023 updated by: Nathaniel Makowski, MetroHealth Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Not yet recruiting
        • MetroHealth Medical Center
        • Contact:
        • Principal Investigator:
          • Nathan Makowski, PhD
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Louis Stokes Cleveland Veterans Affairs Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: IRS-8
Implanted Receiver Stimulator (IRS) delivering 8 channels of stimulation. Appropriate for muscle-based (intramuscular or epimysial) electrodes only
Device: IST 12 & IST 16
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, ~18 weeks post implant, ~44 week post implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, ~18 weeks post implant, ~44-week post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Nathan Makowski, PhD, The MetroHealth System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StudyID00000125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified assessment data will be shared via NICHD DASH

IPD Sharing Time Frame

Data will become available after study completion

IPD Sharing Access Criteria

De-identified data will be available anyone with access to the NICHD DASH repository

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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