Restoration of Upper-extremity Function After Intention-driven Functional Electrical Stimulation Using a Wearable Sleeve in 2 Adults with Chronic Stroke: A Case Series 4352

Abstract

Objectives

To investigate the feasibility of using a wearable, high-density electrode sleeve to provide intention-driven functional electrical stimulation (FES) therapy, and to evaluate the preliminary effects on recovery in 2 adult chronic stroke survivors.

Design

During the 8-week intervention period, therapy was administered using the intention-driven FES sleeve during three 2-hour sessions. After the 8-week intervention period, subjects were monitored in a 10-week follow-up period during which task-oriented training was not administered. However, FES was delivered during this period to enable continued engineering development of the sleeve.

Setting

This study was performed at Battelle Memorial Institute..

Participants

This study enrolled adults with upper limb hemiparesis, stroke-related hand impairment that interferes with the ability to complete activities of daily life, and who were classified as stage 1-6 on the hand subscale of the Chedoke McMaster Stroke assessment. Individuals actively participating in stroke-related upper limb rehabilitation, co-occurring neurological or neuromuscular conditions, or implanted electronic devices were excluded.

Interventions

The intervention was comprised of using an investigational device composed of a high-density grid of electrodes embedded in a sleeve to deliver FES during therapist (occupational therapist)-guided therapy. FES was delivered either (1) by an operator that matched FES to the subject's intention, or (2) by the wearer's own electromyographic signals. The operator-controlled FES system was used twice per week, and the electromyographic-controlled FES system used once per week. At each session, the occupational therapist chose functional tasks, graded them to an appropriate difficulty, and administered practice for approximately 20 minutes before moving on to a new task.

Main Outcome Measures

Main outcome measures include the Action Research Arm Test, the Fugl-Meyer Assessment Upper Extremity, and the Box and Blocks test.

Results

At the conclusion of the 8-week therapy schedule, both subjects demonstrated improvements that exceeded the minimal clinically important difference on the Action Research Arm Test, Fugl-Meyer Assessment Upper Extremity, and the Box and Blocks test. These improvements were sustained during the 10-week follow-up period.

Conclusions

These results provide an initial, preliminary demonstration in 2 stroke survivors of using intention-driven FES therapy incorporating multiple FES-enabled movements using a wearable forearm sleeve. Larger studies are needed to validate these findings. This device has not been approved or cleared as safe or effective by US Food and Drug Administration. This device is limited by US federal law to investigational use.

Disclosures

All authors are employees of Battelle Memorial Institute, which has developed the described NeuroLife Sleeve.