Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy

Kırıkkale University

Status: Enrolling

Conditions: Mollii Suit; Cerebral Palsy

Treatments: Other: Molli Suit Apply

Study type: Interventional

Funder types: Other

Identifiers

NCT06302790

AcuteMolliiSuitEffects

Details and patient eligibility

About

The aim of our study is to examine the acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy.

Full description

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 acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy.

Enrollment: 30 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• volunteering to participate in the study
• Having a diagnosis of spastic CP
• 1 or 2 on the Gross Motor Classification System (GMFCS)
• Between the ages of 4-18.

Exclusion criteria

• Having GMFCS 3,4,5
• Botulinum Toxin A performed before 3 months or surgical intervention before 6 months
• Having an invasive medical pump (baclofen, insulin, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Molli Suit Apply Group (Device On)

Active Comparator group

Description:

Evaluations will be made before the children are dressed in the Mollii Suit, and the evaluations will be repeated after the children are dressed and practiced for 60 minutes.

Treatment:

Other: Molli Suit Apply

Mollii Suit Placebo Group (Device Off)

Placebo Comparator group

Description:

Evaluations will be made before the children are dressed in the Mollii Suit, and the evaluations will be repeated after the children are dressed and applied for 60 minutes with the device in off mode.

Treatment:

Other: Molli Suit Apply

Control Group

No Intervention group

Description:

Children will be evaluated and the evaluations will be repeated 60 minutes later.