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Implant for Walking After Stroke

Primary Purpose

Stroke, Hemiplegia, Gait, Hemiplegic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IRS-8
IST 12 & IST 16
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Stroke

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Louis Stokes Cleveland Veterans Affairs Medical CenterRecruiting
  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implantation, controller development, and evaluation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 18, 2023
Last Updated
June 27, 2023
Sponsor
MetroHealth Medical Center
Collaborators
Case Western Reserve University, Louis Stokes VA Medical Center, Cleveland State University
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1. Study Identification

Unique Protocol Identification Number
NCT05740540
Brief Title
Implant for Walking After Stroke
Official Title
Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center
Collaborators
Case Western Reserve University, Louis Stokes VA Medical Center, Cleveland State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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 - 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia, Gait, Hemiplegic

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implantation, controller development, and evaluation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
IRS-8
Intervention Description
Implanted Receiver Stimulator (IRS) delivering 8 channels of stimulation. Appropriate for muscle-based (intramuscular or epimysial) electrodes only
Intervention Type
Device
Intervention Name(s)
IST 12 & IST 16
Intervention Description
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 Outcome Measure Information:
Title
Difference in Gait speed
Description
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.
Time Frame
baseline, ~18 weeks post implant, ~44 week post implant
Secondary Outcome Measure Information:
Title
Difference in Usability Rating Scale (URS)
Description
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
Time Frame
baseline, ~18 weeks post implant, ~44-week post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Lombardo, MPT
Phone
216-791-3800
Ext
64909
Email
lisa.lombardo2@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan Makowski
Phone
216 791-3800
Ext
63135
Email
nmakowski@metrohealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Makowski, PhD
Organizational Affiliation
The MetroHealth System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes Cleveland Veterans Affairs Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Lombardo, MPT
Phone
216-791-3800
Ext
64909
Email
lisa.lombardo2@va.gov
First Name & Middle Initial & Last Name & Degree
Maura Malenchek, PTA
Phone
216-791-3800
Ext
64989
Email
maura.malenchek@va.gov
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine Hansen, PT
Phone
216-957-3584
Email
khansen1@metrohealth.org
First Name & Middle Initial & Last Name & Degree
Nathan Makowski, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Implant for Walking After Stroke

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