Functional Electrical Stimulation Therapy After Stroke
Completed · Not applicable
Conditions studied: Stroke
In brief
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 electromyography (EMG) and FES Sleeve devices in chronic stroke survivors. The main questions it aims to answer are: * Can these devices be used to administer task-oriented therapy with assistive stimulation at similar doses to current standards of care? * How does therapy using these devices impact the upper limb function in a few chronic stroke survivors? Participants will receive assistive electrical stimulation synchronized to their movement intention while practicing functional tasks with everyday objects over the course of 8 weeks.
Key facts
- Study ID
- NCT06207240
- Run by
- Battelle Memorial Institute
- People needed
- 2
- Starts
- 2022-01-18
- Expected to finish
- 2022-06-08
- Last updated by the study team
- 2024-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Battelle Memorial Institute — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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