Sensory afferent electrical stimulation to improve upper limb function in children with hemiparesis - a randomised controlled trial (SenseUp study protocol).

BACKGROUND: Children with hemiparesis present with sensory and motor deficits, which negatively affect quality of life. Sensory Afferent Electrical Stimulation (SAES) triggers action potentials in afferent nerve fibers, leading to increased sensorimotor afferent input. While proven effective in adults after stroke and safe in children with cerebral palsy through small studies, a systematic and large-scale investigation in the pediatric population is still missing. This protocol describes a study designed to investigate the efficacy and mechanisms of SAES. METHODS: We will recruit 34 children and adolescents with spastic hemiparesis to participate in the prospective, single center, randomized controlled Bayesian phase II trial with a 5-week intervention period and a follow-up examination after 12 weeks. Participants will be randomly assigned to a 5-week SAES intervention or a control group consisting of treatment as usual. Before and after the SAES as well as at 12-week follow-up, clinical measures will be used to assess bimanual and unimanual hand functions (primary outcome: Assisting Hand Assessment AHA). Accelerometry and contactless motion tracking will be applied to evaluate everyday life upper limb functions. Neurophysiological methods such as structural and functional Magnetic Resonance Imaging and Transcranial Magnetic Stimulation will be performed to gain insight into neuroplastic mechanisms underlying SAES and are considered secondary outcomes. DISCUSSION: Previous studies were limited by small cohorts and narrow outcome measures. Our study addresses these gaps while additionally investigating underlying neurophysiological mechanisms in children using MRI and TMS, providing a scientific basis for implementing such stimulation in practice. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, identifier (NCT06536634); kofam.ch, identifier (SNCTP000005950).