The Effects of EXOPULSE Mollii Suit on Motor Functions in Children With Cerebral Palsy (EXOCEP): A Pilot Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Spasticity is a frequent and debilitating symptom in patients with cerebral palsy. It can alter the patients' balance, mobility, as well as their quality of life (QoL). The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous electric nerve stimulation using EXOPULSE Mollii suit, might be of help in this context.

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

• Age between 5 and 12 years.

• Having a clinical diagnosis of unilateral or bilateral spastic cerebral palsy since at least one month.

• Being able to walk freely, with slight limitation or using ancillary equipment's (Gross Motor Function Classification System (GMFCS) score ≤3).

• Having a PBS score \< 45.

• Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale).

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

Locations
Other Locations
France
Centre Hospitalier Intercommunal D'Aix Pertuis
RECRUITING
Aix-en-provence
Centre Medico Chirurgical de Readaptation Des Massues
NOT_YET_RECRUITING
Lyon
Centre de Sante Rossetti
RECRUITING
Nice
Centre de Readaptation Pediatrique D'Oleron
RECRUITING
Saint-trojan-les-bains
Contact Information
Primary
Samar S AYACHE, MD, PhD
samarayache@gmail.com
0149814662
Backup
Moussa A CHALAH, MD, PhD
moussachalah@gmail.com
Time Frame
Start Date: 2023-09-13
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 32
Treatments
Active_comparator: Active Comparator
Active stimulation sessions will last 1 hour each.~Exopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate several groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body.
Sham_comparator: Sham Comparator
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
Related Therapeutic Areas
Sponsors
Leads: Institut De La Colonne Vertebrale Et Des Neurosciences

This content was sourced from clinicaltrials.gov