RECRUITING

Implant for Walking After Stroke

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-16
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05740540

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.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 6-months post stroke
  2. * Age 21 to 75 years old
  3. * Able to ambulate, but does not require the assistance of more than one person
  4. * Walk slower than 0.8m/s during a 10m walk test
  5. * Lower extremity Fugl-Meyer Motor Assessment (FMA) \<= 20
  6. * Reduced peak hip, knee and/or ankle range of motion during stance or swing phases
  7. * Modified Ashworth Scale (MAS) \<= 2 at the above joints during passive flexion and extension
  8. * Innervated and excitable lower extremity and trunk musculature
  9. * Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
  10. * Adequate social support and stability
  11. * Willingness to comply with follow-up procedures
  12. * Neurologically stable as determined by a physician
  1. * Non-English speaking
  2. * Significant range of motion limitations (lacking hip extension, etc.)
  3. * History of spontaneous fractures or other evidence of excessively low bone density
  4. * Acute orthopedic problems (severe scoliosis, joint dislocations, etc.)
  5. * Medical complications (cardiac abnormalities, skin breakdowns, uncontrolled seizures, immunological/pulmonary/renal/circulatory compromise, additional neurologic conditions etc.)
  6. * Cardiovascular or pulmonary disease
  7. * Uncontrolled diabetes or hypertension
  8. * Presence of a demand pacemaker or cardiac defibrillator
  9. * Pregnancy
  10. * Complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.)
  11. * Significant history of repeated falls
  12. * Severely impaired cognition and communication
  13. * Any other medical or psychological condition that would be a contraindication

Contacts and Locations

Study Contact

Lisa Lombardo, MPT
CONTACT
216-791-3800
lisa.lombardo2@va.gov
Nathan Makowski
CONTACT
216 791-3800
nmakowski@metrohealth.org

Principal Investigator

Nathan Makowski, PhD
PRINCIPAL_INVESTIGATOR
The MetroHealth System

Study Locations (Sites)

Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, 44106
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States

Collaborators and Investigators

Sponsor: MetroHealth Medical Center

  • Nathan Makowski, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-05-16
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-05-16
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Stroke
  • Hemiplegia
  • Gait, Hemiplegic