Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy: A Double-Blınd Randomızed Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cerebral Palsy (CP) is the most common developmental disorder in childhood. Individuals' independence in daily living activities and participation in education, games, social and community activities are restricted. Technology applications in the field of rehabilitation are gaining momentum. EXOPULSE Mollii Suit method, one of the newest rehabilitation technology products, is a non-invasive neuromodulation approach with a garment that covers the whole body and electrodes placed inside. Designed to improve motor function by reducing spasticity and pain, the method is based on the principle of reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities. Therefore, the aim of our study is to examine the effectiveness of the Mollii Suit application on gross and fine motor function, spasticity severity, balance, walking, selective motor control, postural control, daily living activities, quality of life, pain and sleep quality in individuals with ambulatory spastic CP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 18
Healthy Volunteers: f
View:

• Being a voluntary participant in the study,

• Having a diagnosis of spastic CP,

• Being between 1-3 on the Gross Motor Classification System (GMFCS),

• Being between the ages of 4 and 18,

• Being able to express pain and discomfort

Locations
Other Locations
Turkey
Gazi University
RECRUITING
Ankara
Contact Information
Primary
Hidayet Cuha, PHD Candidate
hcuha@kastamonu.edu.tr
+90 534 646 01 06
Backup
Merve Ozturk, PHD Student
oozturkmerve@gmail.com
+90 543 426 40 93
Time Frame
Start Date: 2023-11-05
Estimated Completion Date: 2025-11-05
Participants
Target number of participants: 32
Treatments
Experimental: Intervention Group
First group will participate in the Mollii Suit application for 60 minutes 3 days a week. Mollii Suit consists of a pair of trousers and a jacket. It is a neuromodulation garment consisting of a non-invasive removable control unit that sends electrical signals to the user through electrodes inside. The child will wear the Molli Suit when he/she comes to each session, and the child will be asked to sit or lie down throughout the application in order to avoid any interference with the effectiveness of the suit.
No_intervention: Control Group
The control group will continue the routine pediatric physiotherapy program 3 days a week. This program, which includes exercises appropriate to the child's motor function level, includes stair climbing, walking exercises, balance, strengthening and flexibility exercises.
Related Therapeutic Areas
Sponsors
Leads: Kastamonu University
Collaborators: Gazi University

This content was sourced from clinicaltrials.gov