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)
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
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
Parallel
SAES
Other interventionThe experimental intervention consists of SAES with a glove or adhesive electrodes at 20Hz, 300µs, intensity between 2-10mA, during 30 minutes per day, 5x/week, for 5 weeks, combined with conventional occupation therapy. The subsequent therapy sessions will take place at home, with in-between telephone checks.
TAU
Other interventionTreatment as usual
Bimanual hand function
Will be measured with the Assisting Hand Assessment (AHA)
Bimanual hand function
Will be measured with the Assisting Hand Assessment (AHA)
Bimanual hand function in everyday life activities
Will be measured with the Chedoke Arm and Hand Activity Inventory (CAHAI)
Spasticity
Will be assessed via clinical assessments (Modified Ashworth scale)
Strength
Will be assessed via clinical assessments (Dynamometer)
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Insel Gruppe AG, University Hospital Bern
Lead sponsor
University of Bern
Collaborator
