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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:
Participants will receive assistive electrical stimulation synchronized to their movement intention while practicing functional tasks with everyday objects over the course of 8 weeks.
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. Participants in this study will use these devices while practicing functional tasks for about one hour at each session. FES will be applied through the forearm sleeve devices to assist with hand movements and grasps required by functional tasks simulating everyday activities such as turning a key or picking up a phone.
Sessions will be scheduled three days per week for 8 weeks total. Participants will complete clinical assessments at the beginning, midpoint and end of intervention as well as at follow-up sessions 2- and 10-weeks after the end of intervention to track upper limb function and impairment. Each session will last 1.5-2 hours, and participants will be compensated for their time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FES Therapy | Experimental | Intention-driven assistive functional electrical stimulation provided during approximately 1 hour of task-oriented therapy. Sessions will be scheduled 3 days per week for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve | Device | Electrical stimulation will be delivered via the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices to assist with movement during functional task practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test (ARAT) | The Action Research Arm Test (ARAT) will be used to track functional changes from the pre-intervention baseline. The ARAT is a common measure of upper extremity function after stroke ranging from 0 (maximal impairment) to 57 (no impairment). | Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up) |
| Therapy Dose | Therapy Dose was used to estimate the feasibility of the therapy. Therapy Dose will be computed as the average amount of time at each session the subject was engaged in intention-driven, task-oriented functional electrical stimulation therapy, excluding the time needed to set up the system. | Week 0-18 (during the intervention and follow-up periods) |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment-Upper Extremity (UEFM) | The Fugl-Meyer Assessment-Upper Extremity (UEFM) subscore will be used to track impairment changes from the pre-intervention baseline. The UEFM is a common measure of upper extremity impairment after stroke ranging from 0 (maximal impairment) to 66 (no impairment). | Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Meyers, PhD | Principal Biomedical Engineer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Battelle Memorial Institute | Columbus | Ohio | 43201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42343330 | Derived | Baumgart IW, Darrow MJ, Tacca NJ, Dunlap CF, Colachis SC 4th, Kamath A, Schlink BR, Putnam PT, Branch J, Friedenberg DA, Wengerd LR, Meyers EC. Intention-driven functional electrical stimulation therapy using a wearable high-density electrode sleeve in chronic stroke: a case report. J Neuroeng Rehabil. 2026 Jun 24. doi: 10.1186/s12984-026-02051-1. Online ahead of print. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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All participants will receive identical intervention protocols.
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| Box and Block Test (BBT) | The Box and Block Test (BBT) will be used to track dexterity changes from the pre-intervention baseline. The BBT is a common measure of unilateral gross manual dexterity after stroke quantified by the number of blocks transferred between boxes within 60 seconds. | Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up) |
| Nine-Hole Peg Test (NHPT) | The Nine-Hole Peg Test (NHPT) will be used to track dexterity changes from the pre-intervention baseline. The NHPT is a common measure of unilateral manual dexterity after stroke quantified by the time taken to transfer nine pegs from holes to a dish. | Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up) |
| Motor Activity Log | The Motor Activity Log (MAL) will be used to track participants' use of their impaired arm throughout the study. The MAL is widely used to assess how stroke survivors use their more-impaired arm outside the laboratory through semi-structured interviews capturing the amount of use and quality of movement using their arm. | Week 0-8 (during the intervention period) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |