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

NCT06301542 | Completed DMC

• 1 other identifier: 2020P003474a
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke

Keywords

functional electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  1 deployment visit in the laboratory, approximately 4 hours

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

  1 deployment visit in the home, approximately 4 hours

Study Arms (2)

In-laboratory

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

Device: Functional electrical stimulation

In-home

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

Device: Functional electrical stimulation

Interventions

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.

In-home; In-laboratory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Boston University: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: February 7, 2024
• Primary Completion: April 4, 2024
• Study Completion: May 31, 2024
• Last Updated: March 17, 2026

Record last verified: 2024-04

Locations

US (1)