The Effects of EXOPULSE Mollii Suit on Motor Functions in Children With Cerebral Palsy (EXOCEP 2 GER)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cerebral Palsy (CP) is is estimated to be around 1.5-3 per live birth, with prenatal factors accounting for 75% of cases. CP appears in early childhood and persists with age and is characterized by permanent lesions or abnormalities affecting the immature brain. It mainly occurs as a motor system disorder (e.g., abnormal movements or posture) with the presence of hemiplegia, diplegia or tetraplegia, and spastic, dyskinetic or atactic syndromes. .This study will explore the potential clinical benefits of the Molliimethod in children with cerebral palsy. Spasticity impacts balance and mobility, halts the patients quality of life and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. Available interventions that aim on improving spasticity are facing limitations such as varios side effects. Therefore, developing novel therapies such as the EXOPULSE Mollii Suit could help to overcome such limitations and noninvasively improve balance, mobility, quality of life and reduce spasticity and pain in children with CP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: f
View:

⁃ Patients will be included if they

• are between 5 and 12 years of age.

• have a clinical diagnosis of unilateraal or bilateral spastic CP by birth \[15\].

• have a PBS score between a minimum of 15 and a maxmimum of 44 points.

• are able to walk freely, with slight limitation or using ancillary equipment's (GMFCS score ≤3) \[49\].

• are German speakers, able to understand verbal instructions.

• have spasticity with a score of at least 1+ on the MAS

Locations
Other Locations
Germany
Medizinische Hochschule Hannover (MHH)
RECRUITING
Hanover
Pohlig GmbH
RECRUITING
Traunstein
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2024-06-30
Participants
Target number of participants: 34
Treatments
Active_comparator: Active Stimulation
Active sessions will last 1 hour of stimulation per day for 2 weeks. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds.
Sham_comparator: Sham Stimulation
In the sham condition, subjects will be asked to wear the device for 1 hour per day for 2 weeks. During 1 hour use per day, the actual stimulation will last only 1 minute and then will shut off.
Sponsors
Leads: Exoneural Network AB
Collaborators: Ottobock SE & Co. KGaA, Pohlig GmbH, Hannover Medical School

This content was sourced from clinicaltrials.gov