Cerebral PalsyNCT06109129
Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy
A study testing EXOPULSE Mollii Suit in people with Cerebral Palsy and Spasticity, Muscle, run by Kastamonu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spasticity, Muscle
- What is being tested?
- EXOPULSE Mollii Suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2023to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara
Hidayet Cuha, PHD Canditate, +90 534 646 01 06, hcuha@kastamonu.edu.tr
Merve Ozturk, PHD Student, +90 543 426 40 93, oozturkmerve@gmail.com
About this study
Official title: Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy: A Double-Blınd Randomızed Controlled Study
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.
Read the 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.
- Conditions
- Cerebral Palsy, Spasticity, Muscle
- Being tested
- EXOPULSE Mollii Suit
- Keywords
- Cerebral Palsy, Rehabilitation Technology, Spasticity, Electrotherapy
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOPULSE Mollii SuitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Device: EXOPULSE Mollii Suit |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-15 minutes
Secondary outcomes (10)
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.
Measured: 45-60 minutes
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.
Measured: 10-15 minutes
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.
Measured: 15-20 minutes
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.
Measured: 3-5 minutes
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.
Measured: 3-5 minutes
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.
Measured: 15 minutes
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.
Measured: 10-15 minutes
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.
Measured: 15-20 minutes
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.
Measured: 10-15 minutes
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."
Measured: 1-3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start5 Nov 2023
- Primary completion5 Nov 2025 (estimated)
- Study completion5 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Double-Blınd Randomızed Controlled Study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Hidayet Cuha, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109129
- Sponsor's protocol ID
- 2023 - 1137
- Status last verified
- Jul 2025
- First submitted
- 25 Oct 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Serdaroglu A, Cansu A, Ozkan S, Tezcan S. Prevalence of cerebral palsy in Turkish children between the ages of 2 and 16 years. Dev Med Child Neurol. 2006 Jun;48(6):413-6. doi: 10.1017/S0012162206000910.
PubMed 16700929Novak I, Hines M, Goldsmith S, Barclay R. Clinical prognostic messages from a systematic review on cerebral palsy. Pediatrics. 2012 Nov;130(5):e1285-312. doi: 10.1542/peds.2012-0924. Epub 2012 Oct 8.
PubMed 23045562Jones RA, Riethmuller A, Hesketh K, Trezise J, Batterham M, Okely AD. Promoting fundamental movement skill development and physical activity in early childhood settings: a cluster randomized controlled trial. Pediatr Exerc Sci. 2011 Nov;23(4):600-15. doi: 10.1123/pes.23.4.600.
PubMed 22109783Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
PubMed 32086598Booth ATC, Buizer AI, Meyns P, Oude Lansink ILB, Steenbrink F, van der Krogt MM. The efficacy of functional gait training in children and young adults with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2018 Sep;60(9):866-883. doi: 10.1111/dmcn.13708. Epub 2018 Mar 7.
PubMed 29512110Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.
PubMed 29088476Salazar AP, Pagnussat AS, Pereira GA, Scopel G, Lukrafka JL. Neuromuscular electrical stimulation to improve gross motor function in children with cerebral palsy: a meta-analysis. Braz J Phys Ther. 2019 Sep-Oct;23(5):378-386. doi: 10.1016/j.bjpt.2019.01.006. Epub 2019 Jan 23.
PubMed 30712812van Hedel HJA, Severini G, Scarton A, O'Brien A, Reed T, Gaebler-Spira D, Egan T, Meyer-Heim A, Graser J, Chua K, Zutter D, Schweinfurther R, Moller JC, Paredes LP, Esquenazi A, Berweck S, Schroeder S, Warken B, Chan A, Devers A, Petioky J, Paik NJ, Kim WS, Bonato P, Boninger M; ARTIC network. Advanced Robotic Therapy Integrated Centers (ARTIC): an international collaboration facilitating the application of rehabilitation technologies. J Neuroeng Rehabil. 2018 Apr 6;15(1):30. doi: 10.1186/s12984-018-0366-y.
PubMed 29625628Pennati GV, Bergling H, Carment L, Borg J, Lindberg PG, Palmcrantz S. Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity. Front Neurol. 2021 Oct 15;12:706610. doi: 10.3389/fneur.2021.706610. eCollection 2021.
PubMed 34721255Arkkukangas M, Hedberg Graff J, Denison E. Evaluation of the electro-dress Mollii® to affect spasticity and motor function in children with cerebral palsy: Seven experimental single-case studies with an ABAB design. 2022;9(1). doi:10.1080/23311916.2022.2064587
Hedin H, Wong C, Sjödén A. The effects of using an electrodress (Mollii®) to reduce spasticity and enhance functioning in children with cerebral palsy: a pilot study. https://doi.org/101080/2167916920201807602. 2020;24(3):134-143. doi:10.1080/21679169.2020.1807602
Jonasson LL, Sorbo A, Ertzgaard P, Sandsjo L. Patients' Experiences of Self-Administered Electrotherapy for Spasticity in Stroke and Cerebral Palsy: A Qualitative Study. J Rehabil Med. 2022 Feb 14;54:jrm00263. doi: 10.2340/jrm.v53.1131.
PubMed 34935050Nordstrom B, Prellwitz M. A pilot study of children and parents experiences of the use of a new assistive device, the electro suit Mollii. Assist Technol. 2021 Sep 3;33(5):238-245. doi: 10.1080/10400435.2019.1579267. Epub 2019 Apr 4.
PubMed 30945989Flodstrom C, Viklund Axelsson SA, Nordstrom B. A pilot study of the impact of the electro-suit Mollii(R) on body functions, activity, and participation in children with cerebral palsy. Assist Technol. 2022 Jul 4;34(4):411-417. doi: 10.1080/10400435.2020.1837288. Epub 2021 Mar 29.
PubMed 33151822Rubio-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.
PubMed 36767576
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy: A Double-Blınd Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT06109129
- Acronym / sponsor ID
- 2023 - 1137
- Conditions
- Cerebral Palsy, Spasticity, Muscle
- Keywords
- Cerebral Palsy, Rehabilitation Technology, Spasticity, Electrotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 5 Nov 2025 (estimated)
- Study completion
- 5 Nov 2025 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Double-Blınd Randomızed Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: EXOPULSE Mollii SuitFirst 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXOPULSE Mollii SuitEXOPULSE 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. | Device | Intervention Group |
Primary outcome
The Edinburgh Visual Gait Score (EVGS)
Time frame: 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.
10 secondary outcomes
The Gross Motor Function Measure (GMFM)
Time frame: 45-60 minutes
Tardieu Scale
Time frame: 10-15 minutes
Trunk Control Measurement Scale (TCMS)
Time frame: 15-20 minutes
Modified Timed Up and Go Test
Time frame: 3-5 minutes
Modified Functional Reach Test
Time frame: 3-5 minutes
Selective Control Assessment of the Lower Extremity (SCALE)
Time frame: 15 minutes
Functional Independence Measure for Children (WeeFIM)
Time frame: 10-15 minutes
The Cerebral Palsy Quality of Life Questionnaire (CP QOL)
Time frame: 15-20 minutes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 10-15 minutes
The Wong-Baker Faces Pain Rating Scale
Time frame: 1-3 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 16700929Serdaroglu A, Cansu A, Ozkan S, Tezcan S. Prevalence of cerebral palsy in Turkish children between the ages of 2 and 16 years. Dev Med Child Neurol. 2006 Jun;48(6):413-6. doi: 10.1017/S0012162206000910.
- Background: PubMed 23045562Novak I, Hines M, Goldsmith S, Barclay R. Clinical prognostic messages from a systematic review on cerebral palsy. Pediatrics. 2012 Nov;130(5):e1285-312. doi: 10.1542/peds.2012-0924. Epub 2012 Oct 8.
- Background: PubMed 22109783Jones RA, Riethmuller A, Hesketh K, Trezise J, Batterham M, Okely AD. Promoting fundamental movement skill development and physical activity in early childhood settings: a cluster randomized controlled trial. Pediatr Exerc Sci. 2011 Nov;23(4):600-15. doi: 10.1123/pes.23.4.600.
- Background: PubMed 32086598Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
- Background: PubMed 29512110Booth ATC, Buizer AI, Meyns P, Oude Lansink ILB, Steenbrink F, van der Krogt MM. The efficacy of functional gait training in children and young adults with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2018 Sep;60(9):866-883. doi: 10.1111/dmcn.13708. Epub 2018 Mar 7.
- Background: PubMed 29088476Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.
- Background: PubMed 30712812Salazar AP, Pagnussat AS, Pereira GA, Scopel G, Lukrafka JL. Neuromuscular electrical stimulation to improve gross motor function in children with cerebral palsy: a meta-analysis. Braz J Phys Ther. 2019 Sep-Oct;23(5):378-386. doi: 10.1016/j.bjpt.2019.01.006. Epub 2019 Jan 23.
- Background: PubMed 29625628van Hedel HJA, Severini G, Scarton A, O'Brien A, Reed T, Gaebler-Spira D, Egan T, Meyer-Heim A, Graser J, Chua K, Zutter D, Schweinfurther R, Moller JC, Paredes LP, Esquenazi A, Berweck S, Schroeder S, Warken B, Chan A, Devers A, Petioky J, Paik NJ, Kim WS, Bonato P, Boninger M; ARTIC network. Advanced Robotic Therapy Integrated Centers (ARTIC): an international collaboration facilitating the application of rehabilitation technologies. J Neuroeng Rehabil. 2018 Apr 6;15(1):30. doi: 10.1186/s12984-018-0366-y.
- Background: PubMed 34721255Pennati GV, Bergling H, Carment L, Borg J, Lindberg PG, Palmcrantz S. Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity. Front Neurol. 2021 Oct 15;12:706610. doi: 10.3389/fneur.2021.706610. eCollection 2021.
- BackgroundArkkukangas M, Hedberg Graff J, Denison E. Evaluation of the electro-dress Mollii® to affect spasticity and motor function in children with cerebral palsy: Seven experimental single-case studies with an ABAB design. 2022;9(1). doi:10.1080/23311916.2022.2064587
- BackgroundHedin H, Wong C, Sjödén A. The effects of using an electrodress (Mollii®) to reduce spasticity and enhance functioning in children with cerebral palsy: a pilot study. https://doi.org/101080/2167916920201807602. 2020;24(3):134-143. doi:10.1080/21679169.2020.1807602
- Background: PubMed 34935050Jonasson LL, Sorbo A, Ertzgaard P, Sandsjo L. Patients' Experiences of Self-Administered Electrotherapy for Spasticity in Stroke and Cerebral Palsy: A Qualitative Study. J Rehabil Med. 2022 Feb 14;54:jrm00263. doi: 10.2340/jrm.v53.1131.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXOPULSE Mollii Suit in people with Cerebral Palsy and Spasticity, Muscle, run by Kastamonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hidayet Cuha, PHD Candidate (+90 534 646 01 06, hcuha@kastamonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Edinburgh Visual Gait Score (EVGS) (time frame: 10-15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06109129, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.