Clinical Outcomes of Individualized Electrostimulation Using a Wearable Electro Suit and Qualitative Feedback From a Mixed Cohort of Survivors of Stroke and Spinal Cord Injury With Spasticity: Case Series.

Abstract

Background: Various forms of electrical stimulation have been integrated into the multimodal management of spasticity. However, high-frequency electrical stimulation can potentially induce muscle fatigue. The Exopulse Mollii Suit (EMS) is a multichannel full-body garment that delivers low-frequency (20 Hz), low-amplitude (20 V), subthreshold sensory stimulation aimed at reducing spasticity.

Objective: Primarily, we examined the effects of a single session of the EMS on spasticity in 7 participants with chronic stroke or cervical spinal cord injury (SCI), specifically those with upper or lower limb spasticity impacting function and gait who were able to walk with minimal or no assistance (Functional Ambulatory Category scores of 2-5). We assessed the impact on gait and ambulatory function, as well as user perceptions of usability and acceptability.

Methods: Participants wore the EMS for 60 minutes, consisting of 30 minutes of standardized goal-directed activities performed in two 15-minute blocks, interspersed with 15-minute rest breaks. Measurements included the Modified Tardieu Scale with surface electromyography for spasticity and functional mobility tests (Functional Ambulatory Category, 10-meter walk test, 5 times sit-to-stand test, and step test). Spatiotemporal gait parameters were quantified using a markerless vision-based motion capture system using the OpenPose BODY25 pose estimation model.

Results: On the basis of the Modified Tardieu Scale and surface electromyography signals, improvements in spasticity were only observed in 2 participants. However, 4 participants demonstrated faster walking speeds. Improvements in the 5 times sit-to-stand test and step test were noted in 3 and 4 participants, respectively. Spatiotemporal gait parameters revealed improvements in gait symmetry in 6 participants. Qualitative feedback based on the Assistive Technology Usability Questionnaire for People With Neurological Diseases (NATU Quest) returned positive results in 3 participants. Overall outcomes, defined as meeting the individualized goals of each participant, were positive in 4 participants.

Conclusions: This case series provides preliminary evidence that a single session with the EMS may offer benefits for functional mobility and gait quality for individuals with spasticity resulting from stroke or SCI. To our knowledge, this is the first report examining the effects of the EMS in participants with SCI and the first to include spatiotemporal gait parameters associated with its use. However, the small sample size, variable outcomes, and lack of a control group necessitate caution in interpreting these findings and preclude definitive conclusions regarding the efficacy of the EMS. Larger, controlled trials with repeated sessions of EMS use are required to establish the effectiveness and optimal application of the EMS for spasticity management.