Published and ongoing studies
A number of clinical studies are ongoing in several countries, led by renown hospitals and doctors, including Karolinska Institutet and Hvidovre Hospital, on a large panel of more than 350 adults and children, most of which are diagnosed with cerebral palsy (CP), multiple sclerosis (MS) or stroke. The studies completed to date show in part improvements in spasticity, muscle relaxation, associated pain relief, sleep as well as physical abilities such as range-of-motion, balance, hand-arm functions, walking and mobility, and thus in overall quality of life.
Monash University, Australia
“Qualitative study of a transcutaneous electrical stimulation garment (Mollii suit) to reduce pain, improve capabilities and quality of life in children with cerebral palsy.” The qualitative part of the study aimed to examine the acceptability, outcomes of use and costs of the Mollii Suit as an intervention of ten children with cerebral palsy. The intervention period was 6 weeks, in which the participants used Mollii 1 hour every other day. The data was collected via a semi-structured interview with participants and their parents. The results show, among other things, that Mollii is perceived to be 'relaxing' and easy to include in everyday life. Other positive changes were reported such as improvement in attention, energy levels, concentration, sleep, improved standing posture, joint positioning, motor skills and reduced pain. The quantitative part of the study is expected to be published in the end of 2019.
Métier Medical Limited, Australia and LAU Medical Center Rizk Hospital, Lebanon
Led by Jörgen Sandell, PhD and MD Naji Riachi
“Evaluation of a self-administered electrical stimulation using the Mollii suit for the treatment of chronic pain – a placebo-controlled trial.” The study included 50 adult study participants with chronic pain, all diagnosed with fibromyalgia. No one was on pain medication at the time of the study. The placebo trials took place two weeks prior to the effect trial with no changes in everyday lifestyle during the two-week period. The results were measured using a visual analogue scale (VAS) right before, 1 hour after, and 24 hours after the intervention. The study is expected to be published during 2020.
The Eurostars project
Inerventions has been awarded an EU grant within the framework of Horizon 2020 to conduct a multi-center study in close collaboration with Karolinska Institutet, Hvidovre Hospital in Copenhagen and the Medical University of Vienna. The aim is to evaluate the effect of the Mollii suit for stroke and cerebral palsy
Karolinska Institutet, Sweden
Led by Professor Jörgen Borg and Susanne Palmcrantz, PhD
“Effects of using the electrodress Mollii to reduce spasticity and enhance functioning after stroke”. 19 stroke patients were included in the study where the aim was to evaluate if Mollii can reduce spasticity and increase function in patients with stroke. The intervention period was 6 weeks and the primary outcome measure was change in spasticity, which was assessed using a Neuroflexor device. The study is expected to be published during 2019.
Hvidovre Hospital, Denmark
Led by Professor Christian Wong, PhD and consultant in pediatric orthopedics
"The Mollii-suit - A novel method using reciprocal inhibition on children with cerebral palsy, GFMCS IV-V. A 6 month prospective study." 30 children and young adults with cerebral palsy were included in the study where the intervention period were six months and the children used Mollii during one hour, three to four times per week. The purpose of this study was to investigate whether a novel method of using reciprocal inhibition affects range of motion and spasticity on children with cerebral palsy. The results shows an improvement in spasticity in the hamstrings muscle group and quadriceps measured with Modified Ashworth and Modified Tardieu Scale. The passive ROM showed a suggestive trend towards statistically significance different in hamstrings and quadriceps. Individualized goals (GAS) related to function and mobility improved significantly throughout the intervention period.
LAU Métier Medical Limited, Australia and the LAU Medical Center Rizk Hospital
Performed by Jörgen Sandell, PhD and Naji Riachi, MD..
“Effects of the Pain Inhibiting mechanisms of the Mollii Suit on Adults with Chronic pain” A non-randomized study including 200 adult study participants with chronic pain. The intervention consisted of one-hour with the Mollii suit. The used outcome measurement for the study was a Visual Analogue Scale preceding the trial as well as immediately afterwards. A follow up measure was also taken twenty-four hours after the intervention. The study is expected to be published in 2019
Luleå university of technology, Sweden
Led by Birgitta Nordström, PhD and Maria Prellwitz, PhD
“A pilot study of children and parents’ experiences of the use of a new assistive device, the electro suit Mollii.” The qualitative study describes experiences from children with cerebral palsy and their parents regarding the use of the Mollii suit. Individual interviews were conducted with 6 children, age 5-10 years and their parents at the end of a 3-month trial period. All children reported some positive impact and the parents also saw improvements. Examples of positive effects observed were improved ability to perform activities, increased strength and ability to maintain body position, reduced pain, and improved sleep.
Nordstrom, B and Prellwitz, M. A pilot study of children and parents experiences of the use of a new assistive device, the electro suit Mollii. Assist Technol. 2019 Apr 4:1-8.
Falu Hospital, Sweden
Led by Professor Hanne Hedin
”Effects of treatment with Mollii to reduce spasticity on children with cerebral palsy.” An ongoing quantative and qualative study with 17 children between ages 2-10 years with cerebral palsy. Outcome measures in the study are spasticity, range of motion, goal attainment (GAS) and pain. The qualitative data of bowel function, sleep and pain are collected through a daily written journal by the patients. The study is expected to be published during 2019.
National and Kapodistrian University of Athens, Greece
“Evaluation of the efficacy for the Mollii® Treatment of spasticity due to cerebral palsy in young patients, including effects on microcirculation.“ A randomized controlled trial study is performed at the National and Kapodistrian University of Athens. 20 children with cerebral palsy, GMFCS 1-3 have been included. The intervention period was 24 weeks, devided into 3 periods. One period of active use of Mollii, one period without Mollii and one period of inactive use of Mollii (placebo suit). Change in gait pattern, range of motion (ROM) muscle tonus and blood microcirculation is measured. The study is expected to be published during 2019.
Linköping University, Sweden
Led by Professor Per Ertzgaard and Professor Leif Sandsjö
”Evaluation of a self-administered transcutaneous electrical stimulation concept for the treatment of spasticity – a randomised placebo-controlled trial.” The study included 27 participants with spasticity - 12 with cerebral palsy and 15 with stroke. The intervention period was 12 weeks, divided into two periods. 6 weeks with an active Mollii suit and 6 weeks with an inactive Mollii suit (placebo suit). Goal attainment scaling (GAS), change in mobility, arm-hand ability, spasticity and pain were measured at baseline and after 6, 12 and 18 weeks. The results showed an improvement in walking speed. And a significant difference in GAS was also shown during the period of active use of Mollii.
Ertzgaard P, Alwin J, Sörbo A, Lindgren M, Sandsjö L. Evaluation of a self-administered transcutaneous electrical stimulation concept for the treatment of spasticity: a randomized placebo-controlled trial. Eur J Phys Rehabil Med. 2018 Aug;54(4):507-517.
Lithuanian University, Lithuania
Led by Indre Bakaniene, Gintare Urbonaviciene, Kristina Janaviciute and Audrone Prasauskiene
“Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy.” 16 children with CP, GMFCS 1-3 were included in a randomized controlled trial. The subjects were divided into two subgroups - one group (n=8) was using Mollii and the other group (n=8) was given conventional physiotherapy. The intervention period was three weeks and Mollii was used for one hour, three times a week.The results showed improvement in gross motor function and mobility in both groups, and that conventional physiotherapy had no superior efficacy compared to the Inerventions method with Mollii.
Bakaniene I, Urbonaviciene G, Janaviciute K, Prasauskiene A. Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy. Neurol Neurochir Pol. 2018 Sep - Oct;52(5):581-586.
Métier Medical Limited, Australia (distributor of Inerventions)
Led by Jörgen Sandell, PhD
”A case study to assess the effects of an electrical stimulation suit on pain and sleep pattern of an individual diagnosed with chronic fatigue syndrome/ME.” The aim of the study was to investigate whether a daily hour of use for thirty straight days of the Mollii suit would improve measures of pain, sleep and energy level. Results show subjective improvement in the self-assessment evaluation forms, objective changes in sleep monitoring and total daily active hours. The poster was presented at Hunter Disability Expo.
Community Neurological Rehabilitation Service, England
Led by Marsden, S
“Single Case Study: Low threshold electrical stimulation (LTES) using the Mollii suit as treatment modality for severe ataxia in an adult with Multiple Sclerosis” A single case study, was performed on a 40-year old male with primary progressive multiple sclerosis and ataxic symptoms. The ataxia was so significant that the patient had lost the ability to stand within a year. The aim of the study was to see if the use of the LTES (low threshold electrical stimulation) Mollii suit could reduce symptoms of ataxia and improve function in the patient. The outcome measures were Modified Fatigue Impact Scale, Motricity Index, Scale for the Assessment and rating of ataxia (SARA), Arm Activity Measure (ArMA), video of arm movements and slide transfers. The participant wore the Mollii suit for one hour every day which resulted in significant progress in all the above measurements. He was also able to walk 100 metres using a pulpit frame with assistance and he also demonstrated increased independence when feeding and drinking. The author of the study concluded: “It was clearly evident that the Mollii suit was very beneficial to control ataxic movements and demonstrate significant improvements in functional tasks.” Poster at the European Congress of Neuro Rehabilitation, Budapest, Hungary 2019
Hobbs Rehabilitation Centre, UK
Led by Scott Reed, Specialist in physiotherapy
“A case study to assess the effects of an electrical stimulation suit on the functional mobility of an individual with a traumatic brain injury.” The study was performed on a patient with traumatic brain injury. The patient wore Mollii for one hour, and result show objective changes in gait pattern in terms of decrease in difference in step length, a decrease in percentage of time spent in double support and a narrower base of support. It is important to note that no therapy was given between the assessment and re-assessment. The poster was presented at the ACPIN Annual Conference in March 2018 in Manchester, UK.
Hobbs rehabilitation centre, UK
Led by Joe Green, Specialist in physiotherapy
”A case study to assess the effects of an electrical stimulation suit on the functional mobility of an individual with secondary progressive MS.” The study was performed on a patient with MS and showed that the patient improved the quality of movement in the upper extremity after one hour with the Mollii suit. The participant explained that “The Mollii suit lessens the battle between my left and right side, resulting in less energy needed for mobility”. The study was submitted and presented at 2016 MS Trust Conference, UK.