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Overground Robotic Program Preserves Gait in Individuals With Multiple Sclerosis and Moderate to Severe Impairments: A Randomized Controlled Trial

Published:December 11, 2020DOI:https://doi.org/10.1016/j.apmr.2020.12.002

      Highlights

      • Maintaining the ability to walk is an important challenge for individuals with multiple sclerosis (MS).
      • We need new standpoints that integrate exoskeletons into long-term rehabilitation.
      • Overground robots (OR) allow individuals to walk on hard and flat surfaces in a real-world setting.
      • OR training might be a feasible and effective tool for preserving gait ability among MS patients.
      • The article describes in detail an OR program that will allow study replication.

      Abstract

      Objective

      To determine how overground robotic (OR) training added to ongoing rehabilitation affects gait speed, lower extremity function, functional mobility, and fatigue in individuals with multiple sclerosis (MS) and moderate to severe gait impairments.

      Design

      Randomized controlled trial.

      Setting

      Outpatient setting at the Multiple Sclerosis Association of Bizkaia, an association serving MS patients in Bizkaia, Spain.

      Participants

      Individuals with MS (N=36) participated in this interventional study. Inclusion criteria were age of 18 years or older, Expanded Disability Status Scale score between 4.5 and 7, and the need for assistive devices for walking outdoors.

      Interventions

      The control group (CG) engaged in an ongoing rehabilitation program consisting of weekly 1-hour individualized sessions. The intervention group (OR group) also participated in this program in addition to a twice-weekly individualized and progressive OR gait training intervention for 3 months, aiming to reach a maximum of 40 minutes by the end of the 3-month period.

      Main Outcome Measures

      Primary outcome was the 10-meter walking test (10MWT). Secondary variables included the Short Physical Performance Battery, the timed Up and Go (TUG) test, and the Modified Fatigue Impact Scale.

      Results

      The OR group maintained 10MWT performance and significantly improved on the TUG test (P=.049, medium effect size) without increasing fatigue perception. The CG demonstrated a decline on the 10MWT (P=.044, small effect size) and reduced fatigue (P=.024, medium effect size). No time per group interaction was observed for any variable.

      Conclusion

      The evaluated intervention could preserve gait speed and significantly improve functional mobility without increasing perceived fatigue in participants. Thus, OR exoskeletons could be considered a tool to deliver intensive practice of good-quality gait training in individuals with MS and moderate to severe gait impairments. Further studies are necessary to confirm these preliminary results.

      Keywords

      List of abbreviations:

      10MWT (10-meter walking test), ADEMBI (Multiple Sclerosis Association of Bizkaia), CG (control group), MS (multiple sclerosis), OR (overground robot), RAGT (robot-assisted gait training), SPPB (short physical performance battery), T1 (baseline assessment), T2 (assessment after the intervention), TUG (timed Up and Go)
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      References

        • Kobelt G.
        • Thompson A.
        • Berg J.
        • Gannedahl M.
        • Eriksson J.
        • MSCOI Study Group
        European Multiple Sclerosis Platform. New insights into the burden and costs of multiple sclerosis in Europe.
        Mult Scler J. 2017; 23: 1123-1136
        • Heesen C.
        • Bohm J.
        • Reich C.
        • et al.
        Patient perception of bodily functions in multiple sclerosis: gait and visual function are the most valuable.
        Mult Scler. 2008; 14: 988-991
        • Motl R.W.
        Ambulation and multiple sclerosis.
        Phys Med Rehabil Clin N Am. 2013; 24: 325-336
        • Bethoux F.
        Gait disorders in multiple sclerosis.
        Continuum (Minneap Minn). 2013; 19: 1007-1022
        • Thoumie P.
        • Lamotte D.
        • Cantalloube S.
        • et al.
        Motor determinants of gait in 100 ambulatory patients with multiple sclerosis.
        Mult Scler. 2005; 11: 485-491
        • Van Asch P.
        Impact of mobility impairment in multiple sclerosis 2-patients’ perspectives.
        Eur Neurol Rev. 2011; 6: 115-120
        • Feinstein A.
        • Freeman J.
        • Lo A.C.
        Treatment of progressive multiple sclerosis: what works, what does not, and what is needed.
        Lancet Neurol. 2015; 14: 194-207
        • Stern M.
        • Sorkin L.
        • Milton K.
        • et al.
        Aging with multiple sclerosis.
        Phys Med Rehabil Clin N Am. 2010; 21: 403-417
        • Jones D.E.
        • Sutliff M.H.
        • Halper J.
        • et al.
        Summary of comprehensive systematic review: rehabilitation in multiple sclerosis: report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology.
        Neurology. 2016; 87: 646
        • National Clinical Guideline
        National Institute for Health and Care Excellence: clinical guidelines. Multiple sclerosis: management in primary and secondary care.
        National Institute for Health and Clinical Excellence, London2004
        • Beer S.
        • Aschbacher B.
        • Manoglou D.
        • et al.
        Robot-assisted gait training in multiple sclerosis: a pilot randomized trial.
        Mult Scler. 2008; 14: 231-236
        • Schwartz I.
        • Sajin A.
        • Moreh E.
        • et al.
        Robot-assisted gait training in multiple sclerosis patients: a randomized trial.
        Mult Scler. 2012; 18: 881-890
        • Lo A.C.
        • Triche E.W.
        Improving gait in multiple sclerosis using robot-assisted, body weight-supported treadmill training.
        Neurorehabil Neural Repair. 2008; 22: 661-671
        • Vaney C.
        • Gattlen B.
        • Lugon-Moulin V.
        • et al.
        Robotic assisted step training (lokomat) not superior to equal intensity of over-ground rehabilitation in patients with multiple sclerosis.
        Neurorehabil Neural Repair. 2012; 26: 212-221
        • Straudi S.
        • Manfredini F.
        • Lamberti N.
        • et al.
        Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): a randomized controlled trial.
        Mult Scler. 2020; 26: 716-724
        • Swinnen E.
        • Baeyens J.P.
        • Pintens S.
        • et al.
        Trunk muscle activity during walking in persons with multiple sclerosis: the influence of body weight support.
        NeuroRehabilitation. 2014; 34: 323-335
        • VanKammen K.
        • Boonstra A.M.
        • van der Woude L.H.
        • et al.
        The combined effects of guidance force, bodyweight support, and gait speed on muscle activity during able-bodied walking in the Lokomat.
        Clin Biomech (Bristol, Avon). 2016; 36: 65-73
        • Puh U.
        • Baer G.D.
        A comparison of treadmill walking and overground walking in independently ambulant stroke patients: a pilot study.
        Disabil Rehabil. 2009; 31: 202-210
        • Afzal T.
        • Tseng S.C.
        • Lincoln J.
        • et al.
        Exoskeleton-assisted gait training in persons with multiple sclerosis: a single group pilot study.
        Arch Phys Med Rehabil. 2020; 101: 599-606
        • McGibbon C.A.
        • Sexton A.
        • Jayaraman A.
        • et al.
        Evaluation of the Keeogo exoskeleton for assisting ambulatory activities in people with multiple sclerosis: an open-label, randomized, cross-over trial.
        J Neuroeng Rehabil. 2018; 15: 117
        • Masiero S.
        • Poli P.
        • Rosati G.
        • et al.
        The value of robotics systems in stroke rehabilitation.
        Expert Rev Med Devices. 2014; 11: 187-198
        • Thompson A.J.
        • Banwell B.L.
        • Barkhof F.
        • et al.
        Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria.
        Lancet Neurol. 2018; 17: 162-173
        • Kurtzke J.F.
        Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS).
        Neurology. 1983; 33: 1444-1452
        • Berriozabalgoitia R.
        • Sanz B.
        • Fraile-Bermúdez A.B.
        • et al.
        An overground robotic gait training program for people with multiple sclerosis: a protocol for a randomized clinical trial.
        Front Med. 2020; 7: 238
        • Wade D.T.
        • Collin C.
        The Barthel ADL Index: a standard measure of physical disability?.
        Int Disabil Stud. 1988; 10: 64-67
        • Jones K.H.
        • Ford D.V.
        • Jones P.A.
        • et al.
        How people with multiple sclerosis rate their quality of life: an EQ-5D survey via the UK MS register.
        PLoS One. 2013; 8e65640
        • Paltamaa J.
        • Sarasoja T.
        • Leskinen E.
        • et al.
        Measuring deterioration in International Classification of Functioning domains of people with multiple sclerosis who are ambulatory.
        Phys Ther. 2008; 88: 176-190
        • Motl R.W.
        • Learmonth Y.C.
        • Wojcicki T.R.
        • et al.
        Preliminary validation of the short physical performance battery in older adults with multiple sclerosis.
        BMC Geriatr. 2015; 15: 157
        • Nilsagard Y.
        • Lundholm C.
        • Gunnarsson L.G.
        • et al.
        Clinical relevance using timed walk tests and ‘timed up and go’ testing in persons with multiple sclerosis.
        Physiother Res Int. 2007; 12: 105-114
        • Sebastião E.
        • Sandroff B.M.
        • Learmonth Y.C.
        • et al.
        Validity of the timed up and go test as a measure of functional mobility in persons with multiple sclerosis.
        Arch Phys Med Rehab. 2016; 97: 1072-1077
        • Flachenecker P.
        • Kümpfel T.
        • Kallmann B.
        • et al.
        Fatigue in multiple sclerosis: a comparison of different rating scales and correlation to clinical parameters.
        Mult Scler. 2002; 8: 523-526
        • Street T.
        • Taylor P.
        • Swain I.
        Effectiveness of functional electrical stimulation on walking speed, functional walking category, and clinically meaningful changes for people with multiple sclerosis.
        Arch Phys Med Rehab. 2015; 96: 667-672
        • Cohen J.
        Statistical power analysis for the behavioral sciences.
        The concepts of power analysis. 2nd ed. Lawrence Erlbaum Associates, Hillsdale, NJ1998: 8-14
        • Cohen J.
        Statistical power analysis for the behavioral sciences.
        Academic Press, New York1977
        • Johansson S.
        • Ytterberg C.
        • Gottberg K.
        • et al.
        Participation in social/lifestyle activities in people with multiple sclerosis: changes across 10 years and predictors of sustained participation.
        Mult Scler. 2020; 26: 1775-1784
        • Cavanaugh J.T.
        • Gappmaier V.O.
        • Dibble L.E.
        • et al.
        Ambulatory activity in individuals with multiple sclerosis.
        J Neurol Phys Ther. 2011; 35: 26-33