Published & 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, pain related to spasticity, 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.
Métier Medical Limited, Australia and LAU Medical Center Rizk Hospital.
Performed by Naji Riachi, MD and Jörgen Sandell, PhD.
“Evaluation of a Self-administered Electrical Stimulation using the Mollii suit for the treatment of Chronic Pain – a Placebo-controlled trial.” A placebo-controlled study conducted on 50 adult study participants with chronic pain, all diagnosed to have fibromyalgia. None of the patients was on prescription pain medicine at the time of the study. Each patient was using a placebo suit two weeks prior to the active use of the Molli suit for one hour. There were no changes in everyday lifestyle during those two weeks. A visual analog scale was filled just prior to, one hour and twenty four hours after the application of either the placebo or the active use. The study is expected to be published in 2019.
Inerventions has been awarded an EU grant within the framework of Horizon 2020 to conduct a multi-center study in close collaboration with the Karolinska Institute, Hvidovre Hospitale 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 prof Jörgen Borg, PhD, Susanne Palmcrantz.
“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 if Mollii can increase function in patients with Stroke. The intervention period is six weeks and the primary outcome measure is change in spasticity, which is being assesed with a Neuroflexor. Data collection is finalized and the study is expected to be published during 2019.
Hvidovre Hospital, Denmark.
Led by prof PhD, Consultant in Pediatric Orthopedics, Christian Wong.
”Mollii treatment in children with cerebral palsy”. 30 children and young adults with cerebral palsy were included in the study where the intervention period is six months and the children uses Mollii during one hour, three to four times per week. The aim of the study is to evaluate the short and medium-term effect of the reciprocal inhibition mechanism on spasticity. The outcome measures are pain, effects on sleep, bowel movement and medication of 6 months using reciprocal inhibition. Publication expected by end of 2019.
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 Mollii suit therapy. 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 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 three-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.
Birgitta Nordstrom PhD and Maria Prellwitz PhD (2019): A pilot study of children and parents experiences of the use of a new assistive device, the electro suit Mollii, Assistive Technology, DOI: 10.1080/10400435.2019.1579267
Falun Hospital, Sweden.
Led by prof 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 in the scientific journal in 2019.
Kapodistrian University of Athens, Greece.
Led by PhD Maria Protonotariou.
“Evaluation of the efficacy for the Mollii® Treatment of Spasticity due to cerebral palsy in young patients, including effects on microcirculation“. A clinical study with randomized controlled trial-design is ongoing at the Kapodistrian University of Athens. Twenty children with cerebral palsy and GMFCS scores of 1-3 have been included. The study duration is twenty-four weeks and is divided into three periods. One period of active use of Mollii, one washout period without the use of Mollii, and one period of inactive use (placebo suit). The study evaluates changes in gait pattern, muscle range of motion (ROM), muscle tone and blood micorcirculation. The study is expected to be published in 2019.
Linköping Hospital, Sweden.
Led by prof Per Ertzgaard, prof Leif Sandsjö.
”Evaluation of a Self-administered Transcutaneous Electrical Stimulation concept for the treatment of Spasticity – a Randomised Placebo-controlled trial.” A randomized controlled study was conducted with 27 study participants with spasticity. 12 study participants with cerebral palsy and 15 study participants with stroke. The intervention period was 12 weeks, divided into two periods. Six weeks with an active Mollii suit and six 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 shows an improvement in walking speed. And a significant difference in GAS was shown during the period of active use of Mollii. The study was published in the ”European Journal of Physical and Rehabilitation Medicine” Oct 2017.
Lithuanian University, Lithuania.
Led by professors Bakaniene I., Urbonaviciene G., Janaviciute K., Prasauskiene A.
“Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy” The study was a randomized controlled trial and included 16 children with CP, GMFCS 1-3. Two subgroups were included, one group (n=8) used Mollii and one group (n=8) was treated with conventional physical therapy. The intervention period with Mollii was three weeks and Mollii was used during one hour, three times a week. The result show improvement in gross motor function and mobility in both groups, also that conventional physiotherapy has no superior efficacy compared to the Inerventions method with Mollii.
Métier Medical Limited, Australia (distributor of Inerventions)
Performed by PhD Jörgen Sandell.
”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. Result 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 Disabilty Expo.
Hobbs Rehabilitation Centre, England.
Performed 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” A case 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 e.g. decrease in difference in step length, a decrease in percentage of time spent in double support and a narrower base of support. It is also important to note that no therapy was given between the assessment and re-assessment, the patient sat in the waiting room only. The poster was presented at the ACPIN Annual Conference in March 2018 in Manchester.
Hobbs rehabilitation centre, England.
Performed 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” A case study was performed on a patient with MS. The study showed that the patient had improved the quality of movement in the upper extremity after one hour of treament with the Mollii suit. The study 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 in UK.