Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

The goal for this project is to investigate the effects of a 5-week SAES therapy in addition to conventional therapy on both behavioural (sensory and motor) and neurological measures and the underlying mechanisms of treatment response.

The goal of this project to investigate the effects of a 5-week SAES therapy in addition to conventional therapy.

The aim is to investigate whether SAES is more effective than conventional therapy alone in children with hemiparesis. The investigators will assess the efficacy of SAES using novel clinical assessment such as kinematic evaluations and modern neurophysiological measures, namely transcranial magnetic stimulation (TMS) and resting-state functional MRI (rs-fMRI).

It will be expected a benefit for children with hemiparesis after SAES training which may lead to improved bimanual and unimanual functions. Benefits have been reported in adults and in preliminary studies also in children.

Type of study: Randomised controlled clinical trial

Participants with hemiparesis will be included in the study. The study group will receive the SAES training with a glove or adhesive electrodes as a home-based training during 30 minutes per day, 5x/week, for 5 weeks, combined with conventional occupation therapy.

Researchers will compare the SAES group with a group of patients with comparable conditions who receive the prescribed conventional occupational therapy and/or physiotherapy (treatment as usual, TAU)

Eligibility criteria

Qualifiers

Diagnosis of unilateral cerebral palsy/hemiparesis, following unilateral brain lesion, e.g. perinatal/childhood stroke (acquired prior to the age of 16 years)

consistent and stable limitation of hand functions

chronic state (time since lesion >2 years)

aged 6-18 years

Disqualifiers

psychiatric disease that prevents the participant form informed participation and compliance in an adequate manner/setting

Bilateral brain lesion

Recent Botulinum toxin-injections injections (UL, < 6 months)

Hand surgery on paretic hand < 2 years

Trial design

Treatments tested in this trial

  • SAES
  • TAU

Treatment groups

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators