Clinical trial NCT06109129: Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy
Official title: Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy: A Double-Blınd Randomızed Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Spasticity, Muscle
Keywords: Cerebral Palsy
Rehabilitation Technology
Spasticity
Electrotherapy
Lead sponsor: Kastamonu University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2023-10-31
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Double-Blınd Randomızed Controlled Study
Primary purpose: TREATMENT

Brief 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.

Detailed description: Cerebral Palsy (CP) is the most common developmental disorder in childhood and is an umbrella term covering a heterogeneous group of permanent but unchanging movement and posture disorders caused by damage to the developing brain. In a study conducted in Turkey in 2006, the incidence was found to be 4.4 per 1000 live births. While difficulties in selective movement negatively affect motor functions, individuals may also experience difficulties in areas such as communication, behavior, vision, hearing, nutrition, pain and sleep. Individuals' independence in daily living activities and participation in education, games, social and community activities are restricted.

In recent years, the number of systematic reviews and meta-analyses focusing on CP treatments has increased rapidly. These studies are instrumental in providing clinicians and families with newer, safer, and more effective interventions. In a systematic review, it was stated that goal-oriented approaches in the development of gross and fine motor skills prioritize motivation and attention, which are important for neuroplasticity, and that this is necessary for the patient to continue treatment. Rehabilitation technologies such as electrotherapy, virtual reality games, and body weight supported treadmill training, which can be combined with targeted motor training, have been shown to be effective on the patient's gross and fine motor functions.

Technology applications in the field of rehabilitation are gaining momentum. The main reasons for this growth include engineering research, commercial development of rehabilitation products and rapidly growing technological developments. These developments are used in CP rehabilitation to improve motor skills, assist with daily living activities, optimize communication and support academic education.

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. No discomfort or side effects were reported in studies conducted in the pediatric population. In one study, they stated that children felt like superheroes in clothes and that it made them feel good. Families stated that this new approach could be an alternative to current treatments and that it was promising.

In the literature, it has only been applied for the treatment of pain and spasticity in patients with CP, stroke, ataxia and fibromyalgia. Different methodological methods were used in these studies and it was stated that there were inconsistencies between the results. According to a pilot study conducted by Hedin et al., 16 patients with CP at different levels were treated for 60 minutes every other day for 6 weeks, and it was observed that there was a significant decrease in joint range of motion and spasticity severity.

The effectiveness of Mollii Suit on different parameters, especially walking, in individuals with ambulatory CP is unclear and it is stated that better designed studies are needed. 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 criteria: Inclusion Criteria:

* 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 Criteria:

* 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.)

Primary outcomes:
measure: The Edinburgh Visual Gait Score (EVGS)
timeFrame: 10-15 minutes
Secondary outcomes:
measure: The Gross Motor Function Measure (GMFM)
timeFrame: 45-60 minutes
measure: Tardieu Scale
timeFrame: 10-15 minutes
measure: Trunk Control Measurement Scale (TCMS)
timeFrame: 15-20 minutes
measure: Modified Timed Up and Go Test
timeFrame: 3-5 minutes
measure: Modified Functional Reach Test
timeFrame: 3-5 minutes
measure: Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: 15 minutes
measure: Functional Independence Measure for Children (WeeFIM)
timeFrame: 10-15 minutes
measure: The Cerebral Palsy Quality of Life Questionnaire (CP QOL)
timeFrame: 15-20 minutes
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 10-15 minutes
measure: The Wong-Baker Faces Pain Rating Scale
timeFrame: 1-3 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
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