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Completed

NCT Number: NCT06301542

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

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.

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Key information

Conditions

Post-stroke

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

functional electrical stimulation

Device

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.

Primary outcomes

  1. Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients

    Time frame: 1 deployment visit in the laboratory, approximately 4 hours

    Control 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 outcomes

  1. Accurate motion assistance while using the functional electrical stimulation in the laboratory.

    Time frame: 1 deployment visit in the laboratory, approximately 4 hours

    Limb movement will be accurately detected and supplemented with functional electrical stimulation in the laboratory setting.

  2. Accurate motion assistance while using the functional electrical stimulation in the home.

    Time frame: 1 deployment visit in the home, approximately 4 hours

    Limb movement will be accurately detected and supplemented with functional electrical stimulation in the home setting.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Boston University

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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