Clinical and technical evidence

Advice

Published evidence
Overall assessment of the evidence
Recent and ongoing studies

Clinical and technical evidence

A literature search was done for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

Two pilot studies are summarised in this briefing, both done in Sweden and reported on the manufacturer's website. These are an effectiveness study (Westerlund et al. 2012; n=117), and a cost-effectiveness study (Shi et al. 2012; n=35).

Overall assessment of the evidence

The current evidence base for this technology is low in quality and quantity. There are no published randomised controlled studies or high quality comparative observational studies available to assess the effectiveness of the Mollii suit. The pilot studies summarised in table 1, alongside several patient case studies and expert testimony, suggest that the Mollii suit could be clinically and cost effective. However, poor reporting of the pilot studies makes quality assessment and interpretation of findings difficult. It is not clear how well the findings apply to the NHS because baseline care is not clearly described in the studies and the study setting is Sweden.

The available studies have not been published in a peer-reviewed journal. This means that the design, methods and conclusions of these studies have not been critiqued by experts in the field. The studies have academic authorship but some of the authors are directly employed by the manufacturer and this raises the potential for conflicts of interest. It is understood that a multi-centred randomised crossover study is ongoing and this may improve the quality of the evidence base and reduce uncertainty.

Based on the current evidence there is uncertainty about the population group which would benefit most from using the Mollii suit, and whether it is best used as a first-line therapy option or in addition to ongoing care. These 2 treatment strategies could be assessed as 2 distinct interventions in future studies. Clear description and selection of study participants is needed, including information on concurrent therapies. Subgroup analysis of people with different conditions should be considered.

Apart from improvement in specific clinical outcomes, the pilot studies suggest there may be an improvement in quality of life, as well as a reduction in resource use (because study participants cancelled planned healthcare contacts). The size of effect is currently unclear and although short-term side effects are reported to be minimal, the long-term effect of regular use is uncertain. Future studies should consider measuring quality of life and resource use to allow for cost-utility analysis.

Table 1 summarises the clinical and economic evidence as well as its strengths and limitations.

Table 1 Summary of the best available evidence for the Mollii suit

Westerlund et al. (2012)
Study size, design and location	A before and after observational pilot case series of 117 people with cerebral palsy (79%), acquired brain injury or stroke (8%) and other neurological diagnoses (13%) who had used the device for at least 6 months (average 12 to 15 months), in Sweden.
Intervention and comparator(s)	Intervention: the Mollii suit Comparator: none.
Key outcomes	Movement improved in 61% of patients; ability to straighten the hand or fingers improved in 46% and 34% respectively, and general spasticity was reduced in 60%. At baseline, 32% of the patients had planned spasticity treatments (for example, botulinum toxin injection) and 90% of these patients were able to cancel these treatments because of improvement. Use of 1 or more assistive devices, such as wheelchair and walker, was stopped by 24% of the patients. Negative effects on digestion, mobility, spasticity or pain were reported by 4% of patients.
Strengths and limitations	The population and intervention were not fully described. The population group appears to be heterogeneous in terms of health condition and concurrent therapy options such as physiotherapy regimes. No subgroup analysis was given, making interpretation of results difficult. The intervention was not compared directly to a specific form of standard care, or other alternative treatments. Outcomes were not validated (only 'positive' or 'negative' changes from baseline, represented graphically as the proportion of people experiencing change rather than an indication of magnitude) and there was a variable length of follow-up. It is unclear if the findings have potential to be clinically or statistically significant.
Shi et al. (2012)
Study size, design and location	An economic pilot study, in 34 children with cerebral palsy, based on clinical measurements, interviews and a survey before and after use of the Mollii suit in Sweden.
Intervention and comparator(s)	The Mollii suit was compared with oral baclofen, botulinum toxin injection or surgery. A precise definition of the intervention and comparators was not given.
Key outcomes	Spasticity in the hip, knee and foot improved in 100% of the sample. Absolute values (derived using a visual analogue scale) were given graphically for life quality, pain, spasm, daily activity, functional mobility, ability to sit and stand, body structure and function, and gross motor function. Costs were reported in Swedish Krona. Reduced healthcare resource use was reported with use of the intervention, except for an increase in the use of assistive devices. The authors state that the Mollii suit was more effective than all alternative treatments in this study, and less costly than baclofen and surgery (with similar costs to botulinum toxin).
Strengths and limitations	The selection of the sample was reported to be randomised, but no further detail of the baseline patient characteristics was given. Costs were sourced from Swedish providers and from the literature. Non-health care costs, such as work and study costs, were included and this suggests a societal rather than a health and social care perspective. It appears that discounting was not appropriately applied. Sensitivity analysis was only done on costs, but the most and least costly scenarios were not further described. Authors reported graphically that the intervention was as or more effective, and as or less costly, than its comparators thus indicating cost effectiveness. The final outcome of the study is unclear because the composite measure of effectiveness was not clearly defined. Also, it is not clear how effectiveness estimates for the comparator interventions were derived.

Recent and ongoing studies

No ongoing or in-development trials were identified from a search of publically available clinical trial databases. However, the manufacturer identified the following studies that are currently in development:

An international 3-centre randomised crossover study of patients with cerebral palsy and stroke, with an observational study in patients with spinal cord injury in close collaboration with the Karolinska Institute, Hvidovre Hospitale in Copenhagen and the Medical University of Vienna. Status: preliminary work started in October 2016, with a study end date in 2018. Indication: stroke, cerebral palsy and spinal cord injury. Comparators: the Mollii suit.
A clinical trial to compare the effect of the Mollii suit with that previously achieved with botulinum toxin, in children with cerebral palsy (County Hospital in Falun, Sweden). Status: preliminary work has started, and the trial duration will be 6 months. Publication is expected in 2017. Comparators: the Mollii suit, botulinum toxin.