Implant for Walking After Stroke

Launched by METROHEALTH MEDICAL CENTER · Feb 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a special device designed to help people who have had a stroke improve their walking ability. The device is an implanted stimulator that works by sending signals to the nerves in the lower body to enhance movement. The trial has two main phases: first, they will screen participants to see if they qualify for the device, and then, if eligible, participants will have the device implanted and will learn how to use it at home while being monitored over several months for its effectiveness.

To be eligible for this trial, participants must be at least 21 years old and have had a stroke at least six months prior. They should be able to walk with minimal help and have a specific walking speed. Participants will need to be in good overall health and have a supportive environment at home. Throughout the trial, they can expect regular check-ins and evaluations to see how well the device is helping them walk better. This study is a great opportunity for stroke survivors looking to regain their mobility and independence.

Gender

ALL

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