Effects of Mollii Suit in Children With Non-Ambule Cerebral Palsy

Kırıkkale University

Status: Enrolling

Conditions: Mollii Suit; Cerebral Palsy

Treatments: Other: EXOPULSE Mollii Suit method

Study type: Interventional

Funder types: Other

Identifiers

NCT06259864

CerebralPalyMolliiSuit

Details and patient eligibility

About

The aim of our study is to examine the effectiveness of the Mollii Suit application on gross motor function, spasticity, postural control, upper extremity skills, selective motor control, daily living activities, quality of life, pain, sleep, constipation and drooling problems in non-ambulatory individuals with cerebral palsy (CP).

Full description

Our study includes children diagnosed with spastic type cerebral palsy at GMFCS level 4 or 5 who applied to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.

After the patients are separated according to the specified exclusion and inclusion criteria, they will be divided into two groups by simple randomization method.

Evaluations will be made before and after treatment. In addition to normal neurodevelopmental therapy (NGT) and Mollii Suit method will be applied 2 days a week. The total duration of treatment will take 8 weeks. Groups; The first group will consist of children with CP who will receive neurodevelopmental treatment.

The second group will consist of children who will receive the Molli Suit method in addition to neurodevelopmental treatment.

Enrollment: 20 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• GMFCS 4 or 5 with spastic cerebral palsy children
• Volunteering to participate in the study

Exclusion criteria

• Botulinum toxinA injection in the last 3 months
• Surgical intervention involving the musculoskeletal system in the last 6 months
• Having an invasive medical pump (baclofen, insulin, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Neurodevelopmental treatment program group

Active Comparator group

Description:

NDT aims to bring the child to the maximum level of independence possible within the limits of age and ability. Treatment sessions are planned for a certain functional result, and the patient's active participation as much as possible is requested. As the child fulfills postural and motor requirements, the physical therapist provides less assistance and less guidance. Positionings supported by auxiliary materials, appropriate hand contacts, correct ways to hold the child, tonus regulation, family education, environmental regulations and goal-oriented quality movement approaches; These are some of the methods used by the NDT approach, which is based on facilitation, stimulation and communication. Neurodevelopmental treatment physiotherapy session for 2 days in a week, over 8 week.

Treatment:

Other: EXOPULSE Mollii Suit method

Mollii Suit method group

Experimental group

Description:

The Exopulse Mollii Suit is designed to restore normality and healthy balance of muscle groups in the body. The suite uses one of several different forms of neuromodulation, based on gently stimulating the affected muscle groups with electrical signals. This approach has been shown to help resynchronize muscle signals that have been disrupted due to spasticity and muscle groups that may have stopped working together. 58 electrodes embedded in the suit send mild and imperceptible impulses to both tense and spastic muscles and the weakened muscles that balance them. These stimulations not only relax tense muscles and reactivate weak ones, but also restore the natural balance of the group and help the body move as it should. Children will wear the outfit twice a week for 8 weeks and each session will last 60 minutes. During this practice, children will also receive NDT twice a week.

Treatment:

Other: EXOPULSE Mollii Suit method