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Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation

Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06301542
Enrollment
10
Registered
2024-03-08
Start date
2024-02-07
Completion date
2024-05-31
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke

Keywords

functional electrical stimulation

Brief 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.

Interventions

DEVICEFunctional electrical stimulation

The FES system will be placed on the plantar flexors, dorsiflexion, and quadriceps muscles and be paired with the machine learning directed inertial measurement units.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER
Boston University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>= 18 years * Capacity to consent * Post-stroke community-dwelling adults * Ability to follow 3-step commands

Exclusion criteria

* Undomiciled * Active substance use disorder * Active psychosis * Domestic violence or neglect * Inability to communicate with investigators * Other comorbidities that prevent full participation in the research

Design outcomes

Primary

MeasureTime frameDescription
Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients1 deployment visit in the laboratory, approximately 4 hoursControl functional electrical stimulation applied to paretic limb muscles of patients with post-stroke hemiparesis. Based on walking-related activities, the resulting controller will stimulate the target muscle groups with properties and amplitude.

Secondary

MeasureTime frameDescription
Accurate motion assistance while using the functional electrical stimulation in the laboratory.1 deployment visit in the laboratory, approximately 4 hoursLimb movement will be accurately detected and supplemented with functional electrical stimulation in the laboratory setting.
Accurate motion assistance while using the functional electrical stimulation in the home.1 deployment visit in the home, approximately 4 hoursLimb movement will be accurately detected and supplemented with functional electrical stimulation in the home setting.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026