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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

• parental informed consent if \<14 years, informed consent of the patient if \>14 years

Locations
Other Locations
Switzerland
Inselspital
RECRUITING
Bern
Contact Information
Primary
Alisa Gschaidmeier, Dr. med.
alisa.gschaidmeier@insel.ch
031 632 94 24
Backup
Sebastian Grunt, Prof. Dr.
031 632 94 24
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 34
Treatments
Experimental: SAES
Treatment group (SAES)~Interventions: Sensory afferent electrical stimulation (SAES)
Other: Control group
The control intervention (treatment as usual, TAU) consists of the prescribed conventional occupational therapy and/or physiotherapy.
Related Therapeutic Areas
Sponsors
Collaborators: University of Bern
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov