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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109129
• Other study ID #: 2023 - 1137
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2023
• Est. completion date: November 5, 2025

Study information

• Verified date: January 2024
• Source: Kastamonu University
• Contact: Hidayet Cuha, PHD Candidate
• Phone: +90 534 646 01 06
• Email: hcuha[@]kastamonu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: November 5, 2025
• Est. primary completion date: November 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paralysis
• Spasticity, Muscle

Intervention

Device:
• EXOPULSE 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

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Kastamonu University	Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (35)

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Rubio-Zarapuz A, Apolo-Arenas MD, Clemente-Suarez VJ, Costa AR, Pardo-Caballero D, Parraca JA. Acute Effects of a Session with The EXOPULSE Mollii Suit in a Fibromyalgia Patient: A Case Report. Int J Environ Res Public Health. 2023 Jan 26;20(3):2209. doi: 10.3390/ijerph20032209. — View Citation

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10-15 minutes
Secondary	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.	45-60 minutes
Secondary	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.	10-15 minutes
Secondary	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.	15-20 minutes
Secondary	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.	3-5 minutes
Secondary	Modified Functional Reach Test	Performed with a leveled yardstick that has been mounted on the wall at the height of the patient's acromion level in the non-affected arm while sitting in a chair. Hips, knees and ankles positioned are at 90 degree of flexion, with feet positioned flat on the floor. The initial reach is measured with the patient sitting against the back of the chair with the upper-extremity flexed to 90 degrees, measure was taken from the distal end of the third metacarpal along the yardstick. Consists of three conditions over three trials: Sitting with the back to the wall and leaning right, left and Sitting with the unaffected side near the wall and leaning forward.	3-5 minutes
Secondary	Selective Control Assessment of the Lower Extremity (SCALE)	The SCALE tool was designed for clinical administrationand scoring by healthcare professionals, to be used in lessthan 15 minutes without specialized equipment. The toolincludes 'Directions for Administration,' 'Instructions forGrading,' and a 'Score Sheet.' Hip, knee, ankle, subtalar,and toe joints are assessed bilaterally. Sitting andside-lying positions allow evaluation of patients who areunable to stand, permit observation of contralateral limbmovements, and enable the patient to visualize their limbin case of proprioceptive deficits. The following factorswere used to develop the assessment and grading criteria:(1) ability to move each joint selectively; (2) involuntarymovement at other joints including the contralateral limb;(3) ability to reciprocate movement; (4) speed of move-ment; and (5) generation of force as demonstrated byexcursion within the available range of motion.	15 minutes
Secondary	Functional Independence Measure for Children (WeeFIM)	The WeeFIM consists of 18 items that document functional status. The WeeFIM was scored on a 7-level ordinal scale, ranging from: Independent/No Helper (7-6); Dependent/Helper (5); and Assistance 'Hands On' (4-1) Citation[22]. In addition to a total WeeFIM score, constructed from the sum of 18 independent item scores, there are also three sub-domain scores: Self-care and bowel and bladder management items, mobility and cognition.	10-15 minutes
Secondary	The Cerebral Palsy Quality of Life Questionnaire (CP QOL)	The CP QOL uses a 9- point rating scale to measure how caregivers think their child feels (in general, 1 = very unhappy, 9 = very happy), with scores subsequently being converted to a scale ranging from 0 to 100. The primary caregiver QOL-Child form (children aged 4-12) contains 66 items in seven domains: Social well-being and Acceptance, Functioning, Participation and Physical Health, Emotional Well-being, Pain and Impact of Disability, Access to Services, and Family Health.	15-20 minutes
Secondary	Pittsburgh Sleep Quality Index (PSQI)	PSQI questionnaire assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: Subjective sleep quality, sleep latency, sleep duration, habitual, sleep efficiency, SDs, use of sleeping medication, and daytime dysfunction. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range, 0-21). A PSQI global score of =5 is considered to be suggestive of significant sleep disorder.	10-15 minutes
Secondary	The Wong-Baker Faces Pain Rating Scale	The Wong-Baker Faces Pain Rating Scale is a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst."	1-3 minutes