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

Sponsor
Kastamonu University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06109129
Collaborator
Gazi University (Other)
32
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: EXOPULSE Mollii Suit
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A Double-Blınd Randomızed Controlled StudyA Double-Blınd Randomızed Controlled Study
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
All assessments will be performed by an experienced pediatric physiotherapist blinded to the study hypothesis and design. Statistical analysis of the study will be performed by a biostatistician blinded to the study hypotheses.
Primary Purpose:
Treatment
Official Title:
Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy: A Double-Blınd Randomızed Controlled Study
Anticipated Study Start Date :
Nov 5, 2023
Anticipated Primary Completion Date :
Nov 5, 2024
Anticipated Study Completion Date :
Nov 5, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

First group will participate in the Mollii Suit application for 60 minutes 3 days a week. Mollii Suit consists of a pair of trousers and a jacket. It is a neuromodulation garment consisting of a non-invasive removable control unit that sends electrical signals to the user through electrodes inside. The child will wear the Molli Suit when he/she comes to each session, and the child will be asked to sit or lie down throughout the application in order to avoid any interference with the effectiveness of the suit.

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.
No Intervention: Control Group

The control group will continue the routine pediatric physiotherapy program 3 days a week. This program, which includes exercises appropriate to the child's motor function level, includes stair climbing, walking exercises, balance, strengthening and flexibility exercises.

Outcome Measures

Primary Outcome Measures

  1. The Edinburgh Visual Gait Score (EVGS) [10-15 minutes]

    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.

Secondary Outcome Measures

  1. The Gross Motor Function Measure (GMFM) [45-60 minutes]

    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.

  2. Tardieu Scale [10-15 minutes]

    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.

  3. Trunk Control Measurement Scale (TCMS) [15-20 minutes]

    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.

  4. Modified Timed Up and Go Test [3-5 minutes]

    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.

  5. Modified Functional Reach Test [3-5 minutes]

    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.

  6. Selective Control Assessment of the Lower Extremity (SCALE) [15 minutes]

    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.

  7. Functional Independence Measure for Children (WeeFIM) [10-15 minutes]

    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.

  8. The Cerebral Palsy Quality of Life Questionnaire (CP QOL) [15-20 minutes]

    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.

  9. Pittsburgh Sleep Quality Index (PSQI) [10-15 minutes]

    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. The Wong-Baker Faces Pain Rating Scale [1-3 minutes]

    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."

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gazi University Ankara Turkey

Sponsors and Collaborators

  • Kastamonu University
  • Gazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hidayet Cuha, Lecturer (PHd student), Kastamonu University
ClinicalTrials.gov Identifier:
NCT06109129
Other Study ID Numbers:
  • 2023 - 1137
First Posted:
Oct 31, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hidayet Cuha, Lecturer (PHd student), Kastamonu University
Cerebral Palsy
Rehabilitation Technology
Spasticity
Electrotherapy
Additional relevant MeSH terms:
Muscle Spasticity
Paralysis
Cerebral Palsy

Study Results

No Results Posted as of Nov 1, 2023