Clinical trial NCT05740540: Implant for Walking After Stroke
Official title: Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Hemiplegia
Gait, Hemiplegic
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: Louis Stokes VA Medical Center
name: Cleveland State University
First posted: 2023-02-23
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Difference in Gait speed
timeFrame: baseline, ~18 weeks post implant, ~44 week post implant
Secondary outcomes:
measure: Difference in Usability Rating Scale (URS)
timeFrame: baseline, ~18 weeks post implant, ~44-week post implant
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes Cleveland Veterans Affairs Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth System, Ohio
name: Nathan Makowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: