Status:
COMPLETED
Functional Electrical Stimulation Therapy After Stroke
Lead Sponsor:
Battelle Memorial Institute
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this feasibility study is to test the feasibility of providing task-oriented, intention-driven functional electrical stimulation (FES) using the novel NeuroLife FES Sleeve and NeuroLife el...
Detailed Description
Battelle has developed the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices, wearable sleeves that deliver non-invasive functional electrical stimulation (FES) paired with user intention. Par...
Eligibility Criteria
Inclusion
- Males and females ≥18 years old
- Diagnosis of stroke
- Ability to provide appropriate consent to partake in the study
- Ability to follow 3-step commands and deemed by an occupational therapist to have the capacity to complete required upper extremity movements
- Ability to secure transportation to attend scheduled study sessions
- Stroke-related hand impairment that interferes with ability to complete activities of daily living and is classified as Stage 1-6 on the hand subscale of the Chedoke McMaster Stroke Assessment
Exclusion
- Presence of any other clinically significant medical comorbidity for which, in the judgment of the Investigator, participation in the study would pose a safety risk to the subject
- Currently participating in physical rehabilitation (e.g., occupational or physical therapy) for stroke-related upper limb impairment
- Co-occurring neurological condition (e.g., Parkinson's disease, Multiple Sclerosis) or other neuromuscular disorder (e.g., Carpal Tunnel Syndrome, neuropathy) that, in the judgment of the Investigator, may influence study results
- Individuals who are immunosuppressed, have conditions that typically result in becoming immunocompromised, taking chronic steroids, or currently receiving immunosuppressive therapy
- Individuals having or requiring any of the following: implanted pacemaker, life supporting/sustaining equipment, or critical non-removable implantable electronic devices such as an insulin pump.
- Persistent pain ≥ 7/10 in impaired upper extremity, as measured by Visual Analogue Scale
- Individuals whose forearm is determined to be too small or too large to fit the electrode sleeve being investigated.
- Individuals who are pregnant or plan to get pregnant during the course of the study.
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06207240
Start Date
January 18 2022
End Date
June 8 2022
Last Update
January 16 2024
Active Locations (1)
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1
Battelle Memorial Institute
Columbus, Ohio, United States, 43201