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

Post-stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301542
• Other study ID #: 2020P003474
• Status: Recruiting
• Start date: February 7, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: Brigham and Women's Hospital
• Contact: David M Levine, MD MPH MA
• Phone: 617-732-7063
• Email: dmlevine[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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