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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Louis Stokes Cleveland Veterans Affairs Medical Center
RECRUITING
Cleveland
MetroHealth Medical Center
NOT_YET_RECRUITING
Cleveland
Contact Information
Primary
Lisa Lombardo, MPT
lisa.lombardo2@va.gov
216-791-3800
Backup
Nathan Makowski
nmakowski@metrohealth.org
216 791-3800
Time Frame
Start Date: 2023-05-16
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 6
Treatments
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.
Sponsors
Leads: MetroHealth Medical Center
Collaborators: Case Western Reserve University, Cleveland State University, Louis Stokes VA Medical Center

This content was sourced from clinicaltrials.gov