Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
NCT Number: NCT06536634
Acronym: SAES
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemiparesis|Unilateral Cerebral Palsy
Interventions: OTHER: SAES|OTHER: TAU
Sponsor: Insel Gruppe AG, University Hospital Bern
Collaborators: University of Bern
Sex: ALL
Age: CHILD, ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-10-01
Locations: Inselspital, Bern, 3010, Switzerland

Summary:
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)

Primary Outcome Measures: Bimanual hand function, Will be measured with the Assisting Hand Assessment (AHA), 5 weeks (After the treatment)
Secondary Outcome Measures: Bimanual hand function, Will be measured with the Assisting Hand Assessment (AHA), 2 assessments: baseline, follow up (12 weeks)|Bimanual hand function in everyday life activities, Will be measured with the Chedoke Arm and Hand Activity Inventory (CAHAI), 2 assessments: baseline, follow up (12 weeks)|Spasticity, Will be assessed via clinical assessments (Tardieu scale), 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)|Strength, Will be assessed via clinical assessments (Dynamometer, Pinch Grip), 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)|Sensitivity, Will be assessed via clinical assessments (2point discrimination), 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)|Sensitivity, Will be assessed via clinical assessments (Semmes-Weinstein monofilaments), 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)|Unimanual hand function, Will be assessed via clinical assessments (Jebson-Taylor Hand function test), 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)|Stereognosis, Will be assessed via clinical assessments (Functional tactile object recognition test), 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)|Hand function during daily activities, Will be assessed via questionnaires (CHEQ), 2 assessments: baseline, after the treatment (5 weeks)|Mirror movements, Will be assessed via clinical assessments (Woods and Teuber Scale), 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)|Upper limb kinematic activity, Will be assessed with novel sensory measures in an instrumented apartment using DeepLabCut software, 2 assessments: baseline, after the treatment (5 weeks)|MRI - Neurophysiological outcomes, Magnetic resonance imaging (MRI) of the brain will be conducted in a 3-T scanner, lasting approximately one hour (including preparation). Structural (T1-weighted and T2-weighted) and FLAIR imaging will be performed. To visualize white matter integrity, diffusion tensor imaging (DTI) will be conducted. Resting-state functional MRI (rs-fMRI) will be used to study the spontaneous fluctuations in blood oxygen level dependent (BOLD) signal.

Arterial spin labelling will be performed to assess blood flow imbalance., 2 assessments: baseline, after the treatment (5 weeks)|TMS - Neurophysiological outcomes, Neuro-navigated TMS will be used at the Department for Neurosurgery at the University Hospital Bern. Neuro-navigated TMS allows a 3D brain reconstruction to topographically map the neurophysiological responses at the cortical and subcortical levels, using single-pulse (resting and active motor thresholds, motor evoked potential amplitudes and latencies and stimulus recruitment curves) and paired-pulse (intracortical interactions) protocols., 2 assessments: baseline, after the treatment (5 weeks)|Quality of life of Children with hemiparesis, Will be assessed via the Kidscreen-52 questionnaire, which was designed to address generic health related quality of life., 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)|Quality of life of Children with hemiparesis regarding hand function, Will be assessed via the Children's Hand-use Experience Questionnaire (CHEQ). It has been developed for children and adolescents with decreased function in one hand, to evaluate the experience of children and adolescents in using the affected hand in activities where usually two hands are needed., 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)|Reported Pain, Will be assessed via a visual analogue scale regarding the experienced pain on the paretic hand before and after the electrical stimulation., Daily during the treatment phase (duration of treatment phase 5 weeks)