Clinical trial NCT06214975 - References

Stroke — EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2)

Citation(s)

•   Andersen IT, Harrison A, Broholm R, Harder A, Nielsen JB, Bulow J, Pingel J
  Microvascularization is not a limiting factor for exercise in adults with cerebral palsy. J Appl Physiol (1985). 2018 Aug 1;125(2):536-544. doi: 10.1152/japplphysiol.00827.2017. Epub 2018 May 3.
•   Andringa A, van de Port I, van Wegen E, Ket J, Meskers C, Kwakkel G
  Effectiveness of Botulinum Toxin Treatment for Upper Limb Spasticity Poststroke Over Different ICF Domains: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2019 Sep;100(9):1703-1725. doi: 10.1016/j.apmr.2019.01.016. Epub 2019 Feb 21.
•   Aree-uea B, Auvichayapat N, Janyacharoen T, Siritaratiwat W, Amatachaya A, Prasertnoo J, Tunkamnerdthai O, Thinkhamrop B, Jensen MP, Auvichayapat P
  Reduction of spasticity in cerebral palsy by anodal transcranial direct current stimulation. J Med Assoc Thai. 2014 Sep;97(9):954-62.
•   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. doi: 10.1016/j.pjnns.2018.07.003. Epub 2018 Jul 20.
•   Bar-On L, Molenaers G, Aertbelien E, Van Campenhout A, Feys H, Nuttin B, Desloovere K
  Spasticity and its contribution to hypertonia in cerebral palsy. Biomed Res Int. 2015;2015:317047. doi: 10.1155/2015/317047. Epub 2015 Jan 11.
•   Barnes, M
  P (2008). Upper Motor Neuone Syndrome and Spasticity: Clinical Management and Neurophysiology, Cambridge University Press, Cambridge, UK.
•   Baude M, Nielsen JB, Gracies JM
  The neurophysiology of deforming spastic paresis: A revised taxonomy. Ann Phys Rehabil Med. 2019 Nov;62(6):426-430. doi: 10.1016/j.rehab.2018.10.004. Epub 2018 Nov 28.
•   Bethoux F
  Spasticity Management After Stroke. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):625-39. doi: 10.1016/j.pmr.2015.07.003. Epub 2015 Sep 26.
•   Bohannon RW, Smith MB
  Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
•   Bonita R, Beaglehole R
  Recovery of motor function after stroke. Stroke. 1988 Dec;19(12):1497-500. doi: 10.1161/01.str.19.12.1497.
•   Burke D, Wissel J, Donnan GA
  Pathophysiology of spasticity in stroke. Neurology. 2013 Jan 15;80(3 Suppl 2):S20-6. doi: 10.1212/WNL.0b013e31827624a7.
•   Busner J, Targum SD
  The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
•   Camak DJ
  Addressing the burden of stroke caregivers: a literature review. J Clin Nurs. 2015 Sep;24(17-18):2376-82. doi: 10.1111/jocn.12884. Epub 2015 Jun 10.
•   Campbell WI, Lewis S
  Visual analogue measurement of pain. Ulster Med J. 1990 Oct;59(2):149-54.
•   Cech, D
  J., & Martin, S. T. (2012). Chapter 5 - Evaluation of Function, Activity, and Participation. In D. J. Cech & S. T. Martin (Eds.), Functional Movement Development Across the Life Span (Third Edition) (pp. 88-104). Saint Louis: W.B. Saunders.
•   Chan PP, Si Tou JI, Tse MM, Ng SS
  Reliability and Validity of the Timed Up and Go Test With a Motor Task in People With Chronic Stroke. Arch Phys Med Rehabil. 2017 Nov;98(11):2213-2220. doi: 10.1016/j.apmr.2017.03.008. Epub 2017 Apr 7.
•   Cogiamanian F, Ardolino G, Vergari M, Ferrucci R, Ciocca M, Scelzo E, Barbieri S, Priori A
  Transcutaneous spinal direct current stimulation. Front Psychiatry. 2012 Jul 4;3:63. doi: 10.3389/fpsyt.2012.00063. eCollection 2012.
•   Denno MS, Gillard PJ, Graham GD, DiBonaventura MD, Goren A, Varon SF, Zorowitz R
  Anxiety and depression associated with caregiver burden in caregivers of stroke survivors with spasticity. Arch Phys Med Rehabil. 2013 Sep;94(9):1731-6. doi: 10.1016/j.apmr.2013.03.014. Epub 2013 Mar 30.
•   Ertzgaard P, Alwin J, Sorbo A, Lindgren M, Sandsjo 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. doi: 10.23736/S1973-9087.17.04791-8. Epub 2017 Oct 25.
•   Farid L, Jacobs D, Do Santos J, Simon O, Gracies JM, Hutin E
  FeetMe(R) Monitor-connected insoles are a valid and reliable alternative for the evaluation of gait speed after stroke. Top Stroke Rehabil. 2021 Mar;28(2):127-134. doi: 10.1080/10749357.2020.1792717. Epub 2020 Jul 13.
•   Farrar JT, Troxel AB, Stott C, Duncombe P, Jensen MP
  Validity, reliability, and clinical importance of change in a 0-10 numeric rating scale measure of spasticity: a post hoc analysis of a randomized, double-blind, placebo-controlled trial. Clin Ther. 2008 May;30(5):974-85. doi: 10.1016/j.clinthera.2008.05.011.
•   Faul F, Erdfelder E, Lang AG, Buchner A
  G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
•   Flodstrom 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.
•   Gan SM, Tung LC, Tang YH, Wang CH
  Psychometric properties of functional balance assessment in children with cerebral palsy. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):745-53. doi: 10.1177/1545968308316474. Epub 2008 Jul 21.
•   Ganapathy V, Graham GD, DiBonaventura MD, Gillard PJ, Goren A, Zorowitz RD
  Caregiver burden, productivity loss, and indirect costs associated with caring for patients with poststroke spasticity. Clin Interv Aging. 2015 Nov 6;10:1793-802. doi: 10.2147/CIA.S91123. eCollection 2015.
•   Goldstein LB, Bertels C, Davis JN
  Interrater reliability of the NIH stroke scale. Arch Neurol. 1989 Jun;46(6):660-2. doi: 10.1001/archneur.1989.00520420080026.
•   Golicki D, Niewada M, Buczek J, Karlinska A, Kobayashi A, Janssen MF, Pickard AS
  Validity of EQ-5D-5L in stroke. Qual Life Res. 2015 Apr;24(4):845-50. doi: 10.1007/s11136-014-0834-1. Epub 2014 Oct 28.
•   Grassi B, Quaresima V
  Near-infrared spectroscopy and skeletal muscle oxidative function in vivo in health and disease: a review from an exercise physiology perspective. J Biomed Opt. 2016 Sep;21(9):091313. doi: 10.1117/1.JBO.21.9.091313.
•   Gupta AD, Chu WH, Howell S, Chakraborty S, Koblar S, Visvanathan R, Cameron I, Wilson D
  A systematic review: efficacy of botulinum toxin in walking and quality of life in post-stroke lower limb spasticity. Syst Rev. 2018 Jan 5;7(1):1. doi: 10.1186/s13643-017-0670-9.
•   Haefeli M, Elfering A
  Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
•   Johnson, M
  I. (2008). Trancutaneous electrical nerve stimulation (TENS). In: Watson T, ed. Electrotherapy, Evidence based practice, 11th ed. Edinburgh:Churchill Livingstone, 253e296.
•   Krause P, Edrich T, Straube A
  Lumbar repetitive magnetic stimulation reduces spastic tone increase of the lower limbs. Spinal Cord. 2004 Feb;42(2):67-72. doi: 10.1038/sj.sc.3101564.
•   Kuo, C
  -L., & Hu, G.-C. (2018). Post-stroke Spasticity: A Review of Epidemiology, Pathophysiology, and Treatments. Int J Gerontol. 12, 280-284.
•   Lance, J
  (1980). "Symposium synopsis," in Spasticity: Disordered Motor Control, R. G. Feldman, R. R. Young, and W. P. Koella, Eds., pp. 485-494, Yearbook Medical, Chicago, Ill, USA.
•   Lecoffre C, de Peretti C, Gabet A, Grimaud O, Woimant F, Giroud M, Bejot Y, Olie V
  National Trends in Patients Hospitalized for Stroke and Stroke Mortality in France, 2008 to 2014. Stroke. 2017 Nov;48(11):2939-2945. doi: 10.1161/STROKEAHA.117.017640. Epub 2017 Sep 29.
•   Lerdal A, Bakken LN, Kouwenhoven SE, Pedersen G, Kirkevold M, Finset A, Kim HS
  Poststroke fatigue--a review. J Pain Symptom Manage. 2009 Dec;38(6):928-49. doi: 10.1016/j.jpainsymman.2009.04.028.
•   Little WJ
  The classic: Hospital for the cure of deformities: course of lectures on the deformities of the human frame. 1843. Clin Orthop Relat Res. 2012 May;470(5):1252-6. doi: 10.1007/s11999-012-2302-y.
•   Maeda N, Urabe Y, Murakami M, Itotani K, Kato J
  Discriminant analysis for predictor of falls in stroke patients by using the Berg Balance Scale. Singapore Med J. 2015 May;56(5):280-3. doi: 10.11622/smedj.2015033.
•   Mai J, Pedersen E
  Mode of action of dantrolene sodium in spasticity. Acta Neurol Scand. 1979 Jun;59(6):309-16. doi: 10.1111/j.1600-0404.1979.tb02941.x.
•   Malanga G, Reiter RD, Garay E
  Update on tizanidine for muscle spasticity and emerging indications. Expert Opin Pharmacother. 2008 Aug;9(12):2209-15. doi: 10.1517/14656566.9.12.2209.
•   Markus, H
  (2008). Stroke: causes and clinical features. Medicine, 36, 586-91.
•   McDougall J, Chow E, Harris RL, Mills PB
  Near-infrared spectroscopy as a quantitative spasticity assessment tool: A systematic review. J Neurol Sci. 2020 May 15;412:116729. doi: 10.1016/j.jns.2020.116729. Epub 2020 Feb 10.
•   Meseguer-Henarejos AB, Sanchez-Meca J, Lopez-Pina JA, Carles-Hernandez R
  Inter- and intra-rater reliability of the Modified Ashworth Scale: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2018 Aug;54(4):576-590. doi: 10.23736/S1973-9087.17.04796-7. Epub 2017 Sep 13.
•   Mills PB, Dossa F
  Transcutaneous Electrical Nerve Stimulation for Management of Limb Spasticity: A Systematic Review. Am J Phys Med Rehabil. 2016 Apr;95(4):309-18. doi: 10.1097/PHM.0000000000000437.
•   Mukherjee A, Chakravarty A
  Spasticity mechanisms - for the clinician. Front Neurol. 2010 Dec 17;1:149. doi: 10.3389/fneur.2010.00149. eCollection 2010.
•   Ng SS, Hui-Chan CW
  The timed up & go test: its reliability and association with lower-limb impairments and locomotor capacities in people with chronic stroke. Arch Phys Med Rehabil. 2005 Aug;86(8):1641-7. doi: 10.1016/j.apmr.2005.01.011.
•   Nielsen JB, Petersen NT, Crone C, Sinkjaer T
  Stretch reflex regulation in healthy subjects and patients with spasticity. Neuromodulation. 2005 Jan;8(1):49-57. doi: 10.1111/j.1094-7159.2005.05220.x.
•   Nordstrom 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.
•   Palisano RJ, Cameron D, Rosenbaum PL, Walter SD, Russell D
  Stability of the gross motor function classification system. Dev Med Child Neurol. 2006 Jun;48(6):424-8. doi: 10.1017/S0012162206000934.
•   Palmcrantz S, Pennati GV, Bergling H, Borg J
  Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke. J Neuroeng Rehabil. 2020 Aug 10;17(1):109. doi: 10.1186/s12984-020-00740-z.
•   Pandyan AD, Gregoric M, Barnes MP, Wood D, Van Wijck F, Burridge J, Hermens H, Johnson GR
  Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005 Jan 7-21;27(1-2):2-6. doi: 10.1080/09638280400014576. No abstract available.
•   Perrot A, Castanier C, Maillot P, Zitari H
  French validation of the modified-falls efficacy scale (M-FES Fr). Arch Gerontol Geriatr. 2018 Sep-Oct;78:233-239. doi: 10.1016/j.archger.2018.07.001. Epub 2018 Jul 4.
•   Picelli A, Santamato A, Chemello E, Cinone N, Cisari C, Gandolfi M, Ranieri M, Smania N, Baricich A
  Adjuvant treatments associated with botulinum toxin injection for managing spasticity: An overview of the literature. Ann Phys Rehabil Med. 2019 Jul;62(4):291-296. doi: 10.1016/j.rehab.2018.08.004. Epub 2018 Sep 13.
•   Rabchevsky AG, Kitzman PH
  Latest approaches for the treatment of spasticity and autonomic dysreflexia in chronic spinal cord injury. Neurotherapeutics. 2011 Apr;8(2):274-82. doi: 10.1007/s13311-011-0025-5.
•   Ro T, Ota T, Saito T, Oikawa O
  Spasticity and Range of Motion Over Time in Stroke Patients Who Received Multiple-Dose Botulinum Toxin Therapy. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104481. doi: 10.1016/j.jstrokecerebrovasdis.2019.104481. Epub 2019 Nov 4. Erratum In: J Stroke Cerebrovasc Dis. 2020 Jun;29(6):104769.
•   Roche N, Lackmy A, Achache V, Bussel B, Katz R
  Effects of anodal transcranial direct current stimulation over the leg motor area on lumbar spinal network excitability in healthy subjects. J Physiol. 2011 Jun 1;589(Pt 11):2813-26. doi: 10.1113/jphysiol.2011.205161. Epub 2011 Apr 18.
•   Sadowska M, Sarecka-Hujar B, Kopyta I
  Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.
•   Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders
  Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.
•   Sommerfeld DK, Gripenstedt U, Welmer AK
  Spasticity after stroke: an overview of prevalence, test instruments, and treatments. Am J Phys Med Rehabil. 2012 Sep;91(9):814-20. doi: 10.1097/PHM.0b013e31825f13a3.
•   Stevenson T
  Berg balance test. Phys Ther. 1996 Oct;76(10):1124, 1126. doi: 10.1093/ptj/76.10.1124. No abstract available.
•   Stinear C, Ackerley S, Byblow W
  Rehabilitation is initiated early after stroke, but most motor rehabilitation trials are not: a systematic review. Stroke. 2013 Jul;44(7):2039-45. doi: 10.1161/STROKEAHA.113.000968. Epub 2013 May 28. No abstract available.
•   Tuppin P, Riviere S, Rigault A, Tala S, Drouin J, Pestel L, Denis P, Gastaldi-Menager C, Gissot C, Juilliere Y, Fagot-Campagna A
  Prevalence and economic burden of cardiovascular diseases in France in 2013 according to the national health insurance scheme database. Arch Cardiovasc Dis. 2016 Jun-Jul;109(6-7):399-411. doi: 10.1016/j.acvd.2016.01.011. Epub 2016 Apr 11.
•   Vivancos-Matellano F, Pascual-Pascual SI, Nardi-Vilardaga J, Miquel-Rodriguez F, de Miguel-Leon I, Martinez-Garre MC, Martinez-Caballero I, Lanzas-Melendo G, Garreta-Figuera R, Garcia-Ruiz PJ, Garcia-Bach M, Garcia-Aymerich V, Bori-Fortuny I, Aguilar-Barbera M; Spanish Group on Spasticity
  [Guide to the comprehensive treatment of spasticity]. Rev Neurol. 2007 Sep 16-30;45(6):365-75. Spanish.
•   Wade DT
  Measuring arm impairment and disability after stroke. Int Disabil Stud. 1989 Apr-Jun;11(2):89-92. doi: 10.3109/03790798909166398.
•   Ward AB
  A literature review of the pathophysiology and onset of post-stroke spasticity. Eur J Neurol. 2012 Jan;19(1):21-7. doi: 10.1111/j.1468-1331.2011.03448.x. Epub 2011 Jun 27.
•   WHO (2004)
  The atlas of heart disease and stroke / Judith Mackay and George Mensah ; with Shanthi Mendis and Kurt Greenland. World Health Organization. https://apps.who.int/iris/handle/10665/43007
•   WHO (2019)
  Accident vasculaire cérébral (AVC). Disponible sur http://www.who.int/topics/cerebrovascular_accident/fr/
•   Winkler T, Hering P, Straube A
  Spinal DC stimulation in humans modulates post-activation depression of the H-reflex depending on current polarity. Clin Neurophysiol. 2010 Jun;121(6):957-61. doi: 10.1016/j.clinph.2010.01.014. Epub 2010 Feb 11.
•   Wu D, Qian L, Zorowitz RD, Zhang L, Qu Y, Yuan Y
  Effects on decreasing upper-limb poststroke muscle tone using transcranial direct current stimulation: a randomized sham-controlled study. Arch Phys Med Rehabil. 2013 Jan;94(1):1-8. doi: 10.1016/j.apmr.2012.07.022. Epub 2012 Aug 7.
•   Zawawi NSM, Aziz NA, Fisher R, Ahmad K, Walker MF
  The Unmet Needs of Stroke Survivors and Stroke Caregivers: A Systematic Narrative Review. J Stroke Cerebrovasc Dis. 2020 Aug;29(8):104875. doi: 10.1016/j.jstrokecerebrovasdis.2020.104875. Epub 2020 May 23.
•   Zorowitz RD, Gillard PJ, Brainin M
  Poststroke spasticity: sequelae and burden on stroke survivors and caregivers. Neurology. 2013 Jan 15;80(3 Suppl 2):S45-52. doi: 10.1212/WNL.0b013e3182764c86.

The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Stroke (EXOSTROKE 2)"

Details for clinical trial NCT06214975