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

NCT ID: NCT06301542

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-07

Study Completion Date

2024-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Post-stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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In-laboratory

Patients will be brought to the laboratory for functional electrical stimulation mobility assessment.

Functional electrical stimulation

Intervention Type 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.

In-home

Patients will undergo functional electrical stimulation mobility assessment in their home.

Functional electrical stimulation

Intervention Type 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.

Interventions

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Functional 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Levine

David Levine, MD, MPH, MA- Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David M Levine, MD MPH MA

Role: CONTACT

617-732-7063

Lou Awad, PhD, DPT

Role: CONTACT

617-358-3043

Facility Contacts

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David M Levine, MD MPH MA

Role: primary

617-732-7063

Other Identifiers

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2020P003474

Identifier Type: -

Identifier Source: org_study_id

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