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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorKastamonu University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • EXOPULSE Mollii Suit

    Device

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The Edinburgh Visual Gait Score (EVGS)

Set up one of the cameras at the end of the 8m walkway track line to capture a coronal view. Place the second camera facing the center of the walkway to capture the sagittal view. The second camera should be set far enough away so as to capture the middle four meters of each trial. A patient should be able to complete two full strides in this distance. Adjust the cameras to be level with the height of the patient's greater trochanter. Record the patient walking back and forth along the walkway. The patient should be barefoot. Open the video recordings in any video player software and take screenshots of each gait cycle event from both coronal and sagittal views. There are 17 observational parameters that should be measured. Each parameter is scored based on either observed condition or measured joint angles. A three-point scale is used for each parameter. After scores have been assigned for each parameter, all scores should be summed.

Time frame
10-15 minutes

Secondary outcomes

1

The Gross Motor Function Measure (GMFM)

The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. Items span the spectrum of gross motor activities in five dimensions: lying supine-prone (GMFM-A), sitting (GMFM-B), crawling (GMFM-C), standing (GMFM-D), walking, running and jumping (GMFM-E). GMFM is scored as fourpoint likert between "0" (cannot initiate) and "3" (completed) and calculated as percentage. The score of each section can be used alone or the total score can be calculated. The scale ranging from 0 to 100.

Time frame
45-60 minutes
2

Tardieu Scale

It is a method that evaluates the velocity-sensitive nature of spasticity through passive movement. Passive stretching is applied slowly (R2) before and fast (R1) after the limb's fall rate against gravity. The difference between R2 and R1 indicates the severity of spasticity. The angle of full ROM (R2) is taken at a very slow speed (V1). The angle of muscle reaction (R1) is defined as the angle in which a catch or clonus is found during a quick stretch (V3). R1 is then subtracted from R2 and this represents the dynamic tone component of the muscle.

Time frame
10-15 minutes
3

Trunk Control Measurement Scale (TCMS)

The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control, and 10 to the ability to perform dynamic reaching. The items are scored from 0 to 3, with 0 being the inability to perform the task and 3 being the complete performance of the item. It is an active test where the evaluator gives verbal instructions, demonstrates the movement visually or by guiding the participant, and then asks the participant to perform the test. The best attempt out of three is scored.

Time frame
15-20 minutes
4

Modified Timed Up and Go Test

Modified TUG is version of TUG test , procedure for TUG test:The TUG test measure is the time taken, in seconds, by an individual to stand up from a standard arm chair, walk a distance of 3 m, turn, walk back to the chair, and sit down again. The subject wears his/her regular footwear. If participants usually use assistive devices such as cane or walker, they should use them during the test, but this should be indicated on the data collection form. No physical assistance is given. Total 3 trial repeats and average time score is recorded.

Time frame
3-5 minutes

Other outcomes

Sponsors and contacts

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Kastamonu University

Lead sponsor

Gazi University

Collaborator