Effects of Exoskeleton Gait Training on Balance, Load Distribution, and Functional Status in Stroke: A Randomized Controlled Trial

Anna Rojek, Anna Mika, Łukasz Oleksy, Artur Stolarczyk, Renata Kielnar, Anna Rojek, Anna Mika, Łukasz Oleksy, Artur Stolarczyk, Renata Kielnar

Abstract

Background: As a result of stroke, patients have problems with locomotion and transfers, which lead to frequent falls. Recovery after stroke is a major goal of rehabilitation, but it is difficult to choose which treatment method is most beneficial for stroke survivors. Recently, powered robotic exoskeletons are used in treatment to maximize the neural recovery of patients after stroke, but there are no studies evaluating the changes in balance among patients rehabilitated with an exoskeleton. Purpose: The aim of this study was to evaluate the effects of Ekso GT exoskeleton-assisted gait training on balance, load distribution, and functional status of patients after ischemic stroke. Methods: The outcomes are based on 44 patients aged 55-85 years after ischemic stroke who were previously randomly assigned into two groups: experimental (with Ekso GT rehabilitation) and control (with classical rehabilitation). At baseline and after 4 weeks of treatment, the patients were evaluated on balance, load distribution, and functional status using, respectively a stabilometric platform, the Barthel Index, and the Rivermead Mobility Index. Results: In the experimental group, balance improved regarding the variables describing sway area as ellipse major and minor axes. In the control group, improvement was noted in sway velocity. After the therapy, total load distribution on feet in both groups showed a small and insignificant tendency toward reduction in the amount of uninvolved limb loading. In the control group, significant load transfer from the backfoot to the forefoot was noted. Both forms of rehabilitation caused significant changes in functional status. Conclusions: Both training with the use of the Ekso GT exoskeleton and classical physiotherapy lead to functional improvement of patients after ischemic stroke. However, in the experimental group, improvement was observed in a larger number of categories, which may suggest potentially greater impact of treatment with the exoskeleton on functional status. Also, both forms of rehabilitation caused significant changes in balance, but we have noted some trends indicating that treatment with exoskeleton may be more beneficial for some patients. The load transfer from the backfoot to the forefoot observed in the control group was an unfavorable phenomenon. We suggest that the Ekso GT exoskeleton may be a promising tool in the rehabilitation of patients after stroke. Trial registration: Trial ID ACTRN12616000148471.

Keywords: balance; exoskeleton; functional status; ischemic stroke; load distribution; physiotherapy.

Copyright © 2020 Rojek, Mika, Oleksy, Stolarczyk and Kielnar.

Figures

Figure 1
Figure 1
CONSORT flow diagram.
Figure 2
Figure 2
Changes in walking time (A) and number of steps (B) monitored with the Ekso GT during the therapy in the experimental group. pp-value between baseline and 2, 3, and 4 week of therapy.

References

    1. Hankey GJ. Stroke. Lancet. (2017) 389:641–54. 10.1016/S0140-6736(16)30962-X
    1. Mudge S, Stott N. Outcome measures to asses walking ability following after stroke: a systematic review of the literature. Physiotherapy. (2007) 93:189–200. 10.1016/j.physio.2006.12.010
    1. Georgakis MK, Duering M, Wardlaw JM, Dichgans M. WMH and long-term outcomes in ischemic stroke: a systematic review and meta-analysis. Neurology. (2019) 92:e1298–308. 10.1212/WNL.0000000000007142
    1. Stephenson R, Edwards S, Freeman J. Associated reactions, their value in clinical practice. Physiother Res Int. (1998) 3:151–2. 10.1002/pri.123
    1. Michael KM, Allen JK, Macko RF. Reduced ambulatory activity after stroke: the role of balance, gait, and cardiovascular fitness. Arch Phys Med Rehabil. (2005) 86:1552–6. 10.1016/j.apmr.2004.12.026
    1. Kawamoto H, Kamibayashi K, Nakata Y, Yamawaki K, Ariyasu R, Sankai Y. Pilot study of locomotion improvement using hybrid assistive limb in chronic stroke patients. BMC Neurol. (2013) 7:141 10.1186/1471-2377-13-141
    1. Park J, Kim TH. The effects of balance and gait function on quality of life of stroke patients. Neuro Rehabilitation. (2019) 44:37–41. 10.3233/NRE-182467
    1. Collin C, Wade DT, Davies S, Horne V. The barthel ADL index: a reliability study. Int Disabil Stud. (1998) 10:61–3. 10.3109/09638288809164103
    1. Green J, Forster A, Young J. A test-retest reliability study of the Barthel Index, the Rivermead Mobility Index, the Nottingham Extended Activities of Daily Living Scale and the Frenchay Activities Index in stroke patients. Disabil Rehabil. (2001) 23:670–6. 10.1080/09638280110045382
    1. Molteni F, Gasperini G, Gaffuri M, Colombo M, Giovanzana C, Lorenzon C, et al. . Wearable robotic exoskeleton for overground gait training in sub-acute and chronic hemiparetic stroke patients: preliminary results. Eur J Phys Rehabil Med. (2017) 53:676–84. 10.23736/S1973-9087.17.04591-9
    1. Jayaraman A, O'Brien MK, Madhavan S, Mummidisetty CK, Roth HR, Hohl K, et al. . Stride management assist exoskeleton vs functional gait training in stroke: a randomized trial. Neurology. (2019) 92:e263–73. 10.1212/WNL.0000000000006782
    1. Louie DR, Eng JJ. Powered robotic exoskeletons in post stroke rehabilitation of gait: a scoping review. J Neuroeng Rehabil. (2016) 13:53. 10.1186/s12984-016-0162-5
    1. Hornby TG, Campbell DD, Kahn JK, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. (2008) 39:1786–92. 10.1161/STROKEAHA.107.504779
    1. Kubota S, Nakata Y, Eguchi K, Kawamoto H, Kamibayashi K, Sakane M, et al. . Feasibility of rehabilitation training with a newly developed wearable robot for patients with limited mobility. Arch Phys Med Rehabil. (2013) 94:1080–7. 10.1016/j.apmr.2012.12.020
    1. Forlander DA, Bohannon RW. Rivermead Mobility Index: a brief review of research to date. Clin Rehabil. (1999) 13:97–100. 10.1191/026921599675502264
    1. Collen FM, Wade DT, Robb GF, Bradshaw CM. The Rivermead Mobility Index: a further development of the Rivermead Motor Assessment. Int Disabil Stud. (1991) 13:50–4. 10.3109/03790799109166684
    1. Radman L, Forsberg A, Nilsagard Y. Modified Rivermead Mobility Index: a reliable measure in people within 14 days post-stroke. Physiother Theory Pract. (2015) 31:126–9. 10.3109/09593985.2014.960055
    1. Lennon S, Johnson L. The modified rivermead mobility index: validity and reliability. Disabil Rehabil. (2000) 22:833–9. 10.1080/09638280050207884
    1. Mahoney FI, Barthel D. Functional evaluation: the Barthel Index: a simple index of independence useful in scoring improvement in the rehabilitation of the chronically ill. Md State Med J. (1965) 14:56–61.
    1. Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. (1989) 42:703–9. 10.1016/0895-4356(89)90065-6
    1. Ohura T, Hase K, Nakajima Y, Nakayama T. Validity and reliability of a performance evaluation tool based on the modified Barthel Index for stroke patients. BMC Med Res Methodol. (2017) 17:131. 10.1186/s12874-017-0409-2
    1. Tryon WW. Evaluating statistical difference, equivalence, and indeterminacy using inferential confidence intervals: an integrated alternative method of conducting null hypothesis statistical tests. Psychol Methods. (2001) 6:371–86. 10.1037/1082-989X.6.4.371
    1. Nakagawa S, Cuthill IC. Effect size, confidence interval and statistical significance: a practical guide for biologists. Biol Rev Camb Philos Soc. (2007) 82:591–605. 10.1111/j.1469-185X.2007.00027.x
    1. Dunst CJ, Hamby DW. Guide for calculating and interpreting effect sizes and confidence intervals in intellectual and developmental disability research studies. J Intellect Dev Disabil. (2012) 37:89–99. 10.3109/13668250.2012.673575
    1. Nam YG, Lee JW, Park JW, Lee HJ, Nam KY, Park JH, et al. . Effects of electromechanical exoskeleton-assisted gait training on walking ability of stroke patients: a randomized controlled trial. Arch Phys Med Rehabil. (2019) 100:26–31. 10.1016/j.apmr.2018.06.020
    1. Morone G, Bragoni M, Iosa M, De Angelis D, Venturiero V, Coiro P, et al. . Who may benefit from robotic assisted gait training? A randomized clinical trial in patients with subacute stroke. Neurorehabil Neural Repair. (2011) 25:636–644. 10.1177/1545968311401034
    1. Pomarino D, Pomarino A. Plantar static pressure distribution in healthy individuals: percentiles for the evaluation of forefoot loading. Foot Ankle Spec. (2014) 7:293–7. 10.1177/1938640014528973
    1. Coenen P, van Werven G, van Neunen MP, van Dieen JH, Gerrits KH, Janssen TW. Robot-assisted walking vs overground walking in stroke patients: an evaluation of muscle activity. J Rehabil Med. (2012) 44:331–7. 10.2340/16501977-0954
    1. Husemann B, Muller F, Krewer C, Heller S, Koenig E. Effects of locomotion training with assistance of a robot-driven gait orthosis in hemiparetic patients after stroke: a randomized controlled pilot study. Stroke. (2007) 38:349–54. 10.1161/01.STR.0000254607.48765.cb
    1. Yoshimoto T, Shimizu I, Hiroi Y, Kawaki M, Sato D, Nagasawa M. Feasibility and efficacy of high-speed gait training with a voluntary driven exoskeleton robot for gait and balance dysfunction in patients with chronic stroke: nonrandomized pilot study with concurrent control. Int J Rehabil Res. (2015) 38:338–43. 10.1097/MRR.0000000000000132
    1. Hidler J, Nicholson D, Pelliccio M, Brady K, Campbell DD, Kahn JH, et al. . Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Neurorehabil Neural Repair. (2009) 23:5–13. 10.1177/1545968308326632
    1. Mayr A, Kofler M, Quirbach E, Matzak H, Frohlich K, Saltuari L. Prospective, blinded, randomized crossover study of gait rehabilitation in stroke patients using the Lokomat gait orthosis. Neurorehabil Neural Repair. (2007) 21:307–14. 10.1177/1545968307300697
    1. Nilsson A, Vreede KS, Haglund V, Kawamoto H, Sankai Y, Borg J. Gait training early after stroke with a new exoskeleton – the hybrid assistive limb: a study of safety and feasibility. J Neuroeng Rehabil. (2014) 11:92. 10.1186/1743-0003-11-92
    1. Watanabe H, Tanaka N, Inuta T, Saitou H, Yanagi H. Locomotion improvement using a hybrid assistive limb in recovery phase stroke patients: a randomized controlled pilot study. Arch Phys Med Rehabil. (2014) 95:2006–12. 10.1016/j.apmr.2014.07.002
    1. Bruni MF, Melegari C, De Cola MC, Bramanti A, Bramanti P, Calabrò RS. What does best evidence tell us about robotic gait rehabilitation in stroke patients: a systematic review and meta-analysis. J Clin Neurosci. (2018) 48:11–7. 10.1016/j.jocn.2017.10.048

Source: PubMed

3
購読する