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Evaluation of a self-administered transcutaneous electrical stimulation concept for the treatment of spasticity: a randomized placebo-controlled trial
Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Rehabilitation Medicine.ORCID iD: 0000-0001-6464-9130
Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
Sahlgrens Acad, Sweden; Sodra Alvsborg Hosp, Sweden.
Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Rehabilitation Medicine.
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2018 (English)In: European Journal of Physical and Rehabilitation Medicine, ISSN 1973-9087, E-ISSN 1973-9095, Vol. 54, no 4, p. 507-517Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Spasticity is a common consequence of injury to the central nervous system negatively affecting patients everyday activities. Treatment mainly consists of training and different drugs, often with side effects. There is a need for treatment options that can be performed by the patient in their home environment. AIM: The objective of this study was to assess the effectiveness of an assistive technology (AT), Mono, a garment with integrated electrodes for multifocal transcutaneous electrical stimulation intended for self-treatment of spasticity, in study participants with spasticity due to stroke or CP. DESIGN: The study was a randomized, controlled, double-blind study with a cross-over design. SETTING: Participants were recruited from two rehabilitation clinics. Treatments were performed in participants homes and all follow-ups were performed in the two rehabilitation clinics. POPULATION: Thirty-one participants were included in the study and 27 completed the study. Four participants discontinued the study. Two declined participation before baseline and two withdrew due to problems handling the garment. METHODS: Participants used the AT with and without electrical stimulation (active/non-active period) for six weeks each. followed by six weeks without treatment. Goal Attainment Scaling (GAS), change in mobility, arm-hand ability, spasticity and pain were measured at baseline and after 6, 12 and 18 weeks. RESULTS: Fifteen of the 27 participants fulfilled the treatment protocol in terms of recommended use. Deviations were frequent. No statistically significant differences in outcome were found between the active and the non-active treatment periods. During the active period, an improvement was seen in the 10-meter comfortable gait test, time and steps. An improvement was seen in both the active and non-active periods for the GAS. CONCLUSIONS: Compliance was low, partly due to deviations related to the garment, complicating the interpretation of the results. Further research should focus on identifying the target population and concomitant rehabilitation strategies. CLINICAL REHABILITATION IMPACT: The evaluated concept of multifocal transcutaneous electrical stimulation (TES) represents an interesting addition to the existing repertoire of treatments to alleviate muscle spasticity. The evaluated concept allows TES to be self-administered by the patient in the home environment. A more elaborate design of training activities directly related to patients own rehabilitation goals is recommended and may increase the value of the evaluated concept.

Place, publisher, year, edition, pages
EDIZIONI MINERVA MEDICA , 2018. Vol. 54, no 4, p. 507-517
Keywords [en]
Muscle spasticity; Randomized controlled trial; Cerebral palsy; Stroke; Transcutaneous electric nerve stimulation
National Category
Rheumatology and Autoimmunity
Identifiers
URN: urn:nbn:se:liu:diva-151798DOI: 10.23736/S1973-9087.17.04791-8ISI: 000445298800001PubMedID: 29072043OAI: oai:DiVA.org:liu-151798DiVA, id: diva2:1253279
Note

Funding Agencies|Region Ostergotland; Promobilia Foundation; Inerventions AB (Vinnova)

Available from: 2018-10-04 Created: 2018-10-04 Last updated: 2018-11-22
In thesis
1. Studies on Spasticity from an Interventional Perspective
Open this publication in new window or tab >>Studies on Spasticity from an Interventional Perspective
2018 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

This thesis focuses on interventional aspects of spasticity, but has a very holistic approach, grounded in the specialty of Rehabilitation medicine. This means capturing the effects of spasticity, on such a complex biological system as the human being, living in a psychosocial context affecting the situation. When evaluating spasticity there are a number of levels of evidence. The first of course, understanding what we mean with spasticity, where there unfortunately is no consensus. The second level is to study if our treatments affect spasticity in a positive direction. The third is to grasp if a decrease in spasticity improve or normalize patient’s movement patterns. The fourth level investigates if improvement in movement patterns improve patient’s ability to perform activities; and the fifth level, comprising whether this intervention improves life satisfaction. Finally, on a societal level, we wish to investigate whether the improvement in life satisfaction or health related quality of life would motivate society to fund the intervention.

Paper I on Goal Attainment Scaling pointed out necessary aspects to consider when using this instrument. This relates, among other things, to the need of learning (“the art of”) goal setting and deciding the purpose of the measurements. Research and clinical use puts different demands on the instrument, for the latter time-efficiency and simplicity to use being most important. For research, it is important to be able to register deterioration, and this can be achieved using the 6-step version.

In paper II, concerning validation of the portable motion system, we showed this system to be valid for short-term measurements and that the use of Exposure Variation Analysis (EVA) seems to be a valuable tool for graphically elucidating different movements. The equipment needs further development in handling long-term measurements (which is effectuated), and norms for normal movements in different activities has to be produced. The discriminative value of EVA needs confirmation in coming studies. For the future, there is the intriguing possibility of long-term measurements in patients’ every-day life, thereby getting objective measures on how our patients use their abilities, thus capturing the difference between what you can do and what you actually do.

The results from paper III demonstrated a large inequality in Sweden regarding the accessibility of BoNT-A treatment for spasticity. We could also show that treatment with BoNT-A is sound from a health-economic perspective, accounting for the uncertainty of data via the sensitivity analysis. For the future, we need to explore if this inequality also exists for other modes of spasticity treatments, e.g. multidisciplinary spasticity treatment and ITB pumps, and in other countries.

In paper IV evaluating multifocal TES, the results could not confirm efficacy with the treatment according to the protocol of the manufacturer. The results have to be interpreted with care, as low compliance and frequent adverse events made deduction not captured in the RCT study. Further studies are needed in a number of areas, e.g. what is the optimal stimulation frequency, what patients can gain from the treatment and how should adjunct treatment be organized.

In this thesis, I have had the privilege to explore different methods of evaluating spasticity interventions from a multimodal perspective as a starting point in an effort to understand more of this intriguing phenomenon. Some of the research questions above are already in the “pipeline” for coming studies; others are to be planned by our research group and others.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2018. p. 67
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1644
National Category
Nursing Public Health, Global Health, Social Medicine and Epidemiology
Identifiers
urn:nbn:se:liu:diva-152853 (URN)10.3384/diss.diva-152853 (DOI)9789176852095 (ISBN)
Public defence
2018-11-09, Belladonna, ingång 76, Campus US, Linköping, 13:00 (English)
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Supervisors
Available from: 2018-11-22 Created: 2018-11-22 Last updated: 2019-09-30Bibliographically approved

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