RecruitingNot ApplicableNCT06109129

Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy

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


Sponsor

Kastamonu University

Enrollment

32 participants

Start Date

Nov 5, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 YearsMax Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria4

  • Being between 4-5 on Gross Motor Classification System (GMFCS)
  • Having Botolunim Toxin A application before 3 months
  • Having a surgical intervention before 6 months
  • Having a shunt or an invasive medical pump (baclofen, insulin, etc.)

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Interventions

DEVICEEXOPULSE Mollii Suit

EXOPULSE Mollii Suit is a personal assistive medical device which is used for low energy whole body transcutaneous electrical stimulation - 20 Volt and 20 Hz. It is composed of a control unit, a jacket and pants with 58 embedded electrodes in direct contact with the skin. EXOPULSE Mollii Suit is used for activation of muscles or relaxation of spastic muscles mediated by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical signal to an antagonistic muscle, the spastic muscle may subsequently relax.


Locations(1)

Gazi University

Ankara, Turkey (Türkiye)

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NCT06109129


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