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.

Study Overview

• Status: Completed
• Conditions: Post-stroke
• Intervention / Treatment: Device: Functional electrical stimulation

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Twenty post-stroke community-dwelling adults will participate in a single in-laboratory and in-home visit, performing 5x sit-to-stand (5XSST), 5x Comfortable and 3x Fast walking speed at a 5M distance, and 5x modified Timed Up and Go (TUG). The tests will be performed twice: once with and without the task aware-neuroprosthesis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
In-laboratory; Patients will be brought to the laboratory for functional electrical stimulation mobility assessment.	Device: 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.
In-home; Patients will undergo functional electrical stimulation mobility assessment in their home.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients	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.	1 deployment visit in the laboratory, approximately 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accurate motion assistance while using the functional electrical stimulation in the laboratory.	Limb movement will be accurately detected and supplemented with functional electrical stimulation in the laboratory setting.	1 deployment visit in the laboratory, approximately 4 hours
Accurate motion assistance while using the functional electrical stimulation in the home.	Limb movement will be accurately detected and supplemented with functional electrical stimulation in the home setting.	1 deployment visit in the home, approximately 4 hours

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Boston University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: functional electrical stimulation
• Other Study ID Numbers: 2020P003474a

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No