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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 deployment visit in the home, approximately 4 hours
Awards & highlights
Study Summary
The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles with and without the FES system. Initially, the context-aware motion assessment and neuroprosthetic control in a clinic will transition to in-home settings as the study progresses, broadening its application for safe and effective use at home.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 deployment visit in the home, approximately 4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 deployment visit in the home, approximately 4 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients
Secondary outcome measures
Accurate motion assistance while using the functional electrical stimulation in the home.
Accurate motion assistance while using the functional electrical stimulation in the laboratory.
Trial Design
2Treatment groups
Experimental Treatment
Group I: In-laboratoryExperimental Treatment1 Intervention
Patients will be brought to the laboratory for functional electrical stimulation mobility assessment.
Group II: In-homeExperimental Treatment1 Intervention
Patients will undergo functional electrical stimulation mobility assessment in their home.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Functional electrical stimulation
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Boston UniversityOTHER
456 Previous Clinical Trials
9,941,549 Total Patients Enrolled
5 Trials studying Stroke
2,204 Patients Enrolled for Stroke
Brigham and Women's HospitalLead Sponsor
1,618 Previous Clinical Trials
11,471,657 Total Patients Enrolled
17 Trials studying Stroke
1,168,498 Patients Enrolled for Stroke
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