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

Recruiting

• Conditions: Post-stroke
• Interventions: Device: Functional electrical stimulation

• Registration Number: NCT06301542
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
In-laboratory	Functional electrical stimulation	Patients will be brought to the laboratory for functional electrical stimulation mobility assessment.
In-home	Functional electrical stimulation	Patients will undergo functional electrical stimulation mobility assessment in their home.

Primary Outcome Measures

Name	Time	Method
Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients	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 Outcome Measures

Name	Time	Method
Accurate motion assistance while using the functional electrical stimulation in the laboratory.	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.
Accurate motion assistance while using the functional electrical stimulation in the home.	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States