Technological Balance and Gait Rehabilitation in Patients With Multipl
Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis: Effects on Functional, Motor and Cognitive Outcomes (ROAR-MS).
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Technological rehabilitation
What it measured
Main measures
Berg Balance Scale
Change from Baseline BBS at 4 and 8 weeks
Walking and mobility
Other measures (15)
Modified Fatigue Impact Scale (MFIS)
Change from Baseline MFIS at 4 and 8 weeks
Thinking and memoryFatigueArm and hand functionFatigue Scale for Motor and Cognitive Function (FSMC)
Change from Baseline FSMC at 4 and 8 weeks
Thinking and memoryFatigueTimed Up and Go test (TUG)
Change from Baseline TUG at 4 and 8 weeks
Walking and mobilityAmbulation Index (AI)
Change from Baseline Ambulation Index at 4 and 8 weeks
Walking and mobilityWalking handicap scale (WHS)
Change from Baseline Walking handicap scale at 4 and 8 weeks
Walking and mobilityPhysical functionFunctional Ambulation Classification (FAC)
Change from Baseline Functional Ambulation Classification at 4 and 8 weeks
VisionWalking and mobility10 Meter Walk Test (10mWT)
Change from Baseline 10 Meter Walk Test at 4 and 8 weeks
Walking and mobilitySix-minute walk test (6MWT)
Change from Baseline Six-minute walk test at 4 and 8 weeks
Walking and mobilityPhysical functionMultiple Sclerosis Walking Scale (MSWS-12)
Change from Baseline Multiple Sclerosis Walking Scale at 4 and 8 weeks
Walking and mobilityModified Barthel Index (mBI)
Change from Baseline mBI at 4 and 8 weeks
Walking and mobilityBladder, bowel and sexual function
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
Inclusion criteria
* Definitive diagnosis of multiple sclerosis according to McDonald criteria; * Age between 18 and 65 years; * Pyramidal or cerebellar system with a score ≥ 2 on the EDSS; * EDSS between 2 and 3; * Ability to stand without support for 60 seconds; * Stability of disease-modifying treatment and absence of clinical relapse of the disease for at least 1 year; * Cognitive ability to execute simple orders and understand the physiotherapist's instructions [assessed by Token Test (score ≥ 26.5)]; * Ability to understand and sign informed consent.
Exclusion criteria
* Significant visual impairment, defined by a visual system score ≥ 2 on the EDSS; * Presence of vestibular disorders unrelated to MS; * Presence of psychiatric disorders or severe cognitive impairment, i.e. a Mini Mental State Examination (MMSE) score \< 24 (15); * Presence of cardiovascular and respiratory disorders; * Inability to provide informed consent.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Multiple sclerosis (MS) is a chronic, inflammatory and neurodegenerative disease of the central nervous system that often results in motor and/or cognitive impairment. Epidemiologically, the onset occurs between the ages of 20 and 40, with a peak around the age of 30. MS is an extremely heterogeneous disease in terms of signs and symptoms, both in terms of the neurological systems involved and the degree of impairment and severity. The most common symptoms include, among others, difficulty walking and lack of balance. The lack of stability and coordination reduces independence and mobility, predisposing people with MS to accidental falls and compromising mobility in daily life. Another symptom that characterises MS is cognitive impairment, which mainly alters information processing speed and short- and long-term memory. MS-related cognitive impairment is detectable at every stage of the disease. Very often, people with MS have co-existing cognitive and motor deficits, which add to the complexity of managing MS. In order to address this condition, a treatment strategy that combines cognitive and motor rehabilitation needs to be identified. Despite the increasing availability of effective drug therapies that may impact on balance, rehabilitation is a very important means to counteract the progression of disability and improve physical function, affecting social participation and improving quality of life. In recent years, rehabilitation makes use of various robotic devices, which are based on repeatable, intense and motivating exercises, integrated with an enriched virtual environment, capable of improving the quality of movement. In light of the literature, which mainly focuses on robotic therapy for walking, this pilot study aims to evaluate the effects of a specific robotic treatment for balance in MS patients. The primary objective of the study is the evaluation of the effects of technological rehabilitation by means of a robotic platform (Hunova® Movendo Technology srl, Genoa, IT) on static balance. The secondary objective is the evaluation of the effects of technological rehabilitation by means of a robotic platform (Hunova® Movendo Technology srl, Genoa, IT) 1. on dynamic balance and walking (assessed with clinical and instrumental scales) 2. on fatigue and cognitive performance in terms of sustained attention, dual-task cost and cognitive-motor interference; 3. on quality of life.
Papers
Results
Kamm CP, Uitdehaag BM, Polman CH. Multiple sclerosis: current knowledge and future outlook. Eur Neurol. 2014;72(3-4):132-41. doi: 10.1159/000360528. Epub 2014 Jul 30.Results
Martin CL, Phillips BA, Kilpatrick TJ, Butzkueven H, Tubridy N, McDonald E, Galea MP. Gait and balance impairment in early multiple sclerosis in the absence of clinical disability. Mult Scler. 2006 Oct;12(5):620-8. doi: 10.1177/1352458506070658.Results
Morris ME, Cantwell C, Vowels L, Dodd K. Changes in gait and fatigue from morning to afternoon in people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2002 Mar;72(3):361-5. doi: 10.1136/jnnp.72.3.361.Results
Cattaneo D, Jonsdottir J. Sensory impairments in quiet standing in subjects with multiple sclerosis. Mult Scler. 2009 Jan;15(1):59-67. doi: 10.1177/1352458508096874. Epub 2008 Oct 9.Results
Sosnoff JJ, Shin S, Motl RW. Multiple sclerosis and postural control: the role of spasticity. Arch Phys Med Rehabil. 2010 Jan;91(1):93-9. doi: 10.1016/j.apmr.2009.09.013.Results
Prosperini L, Castelli L. Spotlight on postural control in patients with multiple sclerosis. Degener Neurol Neuromuscul Dis. 2018 Apr 3;8:25-34. doi: 10.2147/DNND.S135755. eCollection 2018.Results
Benedict RH, Cookfair D, Gavett R, Gunther M, Munschauer F, Garg N, Weinstock-Guttman B. Validity of the minimal assessment of cognitive function in multiple sclerosis (MACFIMS). J Int Neuropsychol Soc. 2006 Jul;12(4):549-58. doi: 10.1017/s1355617706060723.Results
Amato MP, Hakiki B, Goretti B, Rossi F, Stromillo ML, Giorgio A, Roscio M, Ghezzi A, Guidi L, Bartolozzi ML, Portaccio E, De Stefano N; Italian RIS/MS Study Group. Association of MRI metrics and cognitive impairment in radiologically isolated syndromes. Neurology. 2012 Jan 31;78(5):309-14. doi: 10.1212/WNL.0b013e31824528c9. Epub 2012 Jan 18.Results
Langdon DW. Cognition in multiple sclerosis. Curr Opin Neurol. 2011 Jun;24(3):244-9. doi: 10.1097/WCO.0b013e328346a43b.Results
Prosperini L, Tomassini V, Castelli L, Tacchino A, Brichetto G, Cattaneo D, Solaro CM. Exergames for balance dysfunction in neurological disability: a meta-analysis with meta-regression. J Neurol. 2021 Sep;268(9):3223-3237. doi: 10.1007/s00415-020-09918-w. Epub 2020 May 23.
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History
- Status changed from Recruiting to Status unknown
Started
Sept 2023
Main results due
Mar 2024
Finished
May 2026