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

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Mass General Brigham

Status

Enrolling

Conditions

Post-stroke

Treatments

Device: Functional electrical stimulation

Study type

Observational

Funder types

Other

Identifiers

NCT06301542
2020P003474

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Lou Awad, PhD, DPT; David M Levine, MD MPH MA

Data sourced from clinicaltrials.gov

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