Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility

Anneli Nilsson, Katarina Skough Vreede, Vera Häglund, Hiroaki Kawamoto, Yoshiyuki Sankai, Jörgen Borg, Anneli Nilsson, Katarina Skough Vreede, Vera Häglund, Hiroaki Kawamoto, Yoshiyuki Sankai, Jörgen Borg

Abstract

Background: Intensive task specific training early after stroke may enhance beneficial neuroplasticity and functional recovery. Impaired gait after hemiparetic stroke remains a challenge that may be approached early after stroke by use of novel technology. The aim of the study was to investigate the safety and feasibility of the exoskeleton Hybrid Assistive Limb (HAL) for intensive gait training as part of a regular inpatient rehabilitation program for hemiparetic patients with severely impaired gait early after stroke.

Methods: Eligible were patients until 7 weeks after hemiparetic stroke. Training with HAL was performed 5 days per week by the autonomous and/or the voluntary control mode offered by the system. The study protocol covered safety and feasibility issues and aspects on motor function, gait performance according to the 10 Meter Walking Test (10MWT) and Functional Ambulation Categories (FAC), and activity performance.

Results: Eight patients completed the study. Median time from stroke to inclusion was 35 days (range 6 to 46). Training started by use of the autonomous HAL mode in all and later switched to the voluntary mode in all but one and required one or two physiotherapists. Number of training sessions ranged from 6 to 31 (median 17) and walking time per session was around 25 minutes. The training was well tolerated and no serious adverse events occurred. All patients improved their walking ability during the training period, as reflected by the 10MWT (from 111.5 to 40 seconds in median) and the FAC (from 0 to 1.5 score in median).

Conclusions: The HAL system enables intensive training of gait in hemiparetic patients with severely impaired gait function early after stroke. The system is safe when used as part of an inpatient rehabilitation program for these patients by experienced physiotherapists.

Figures

Figure 1
Figure 1
Illustration of Illustration of training training.
Figure 2
Figure 2
Walking distance by HAL training session.

References

    1. Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009;8:355–369. doi: 10.1016/S1474-4422(09)70025-0.
    1. Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of adult stroke rehabilitation care: a clinical practice guideline. Stroke. 2005;36:100–143. doi: 10.1161/01.STR.0000180861.54180.FF.
    1. Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen stroke study. Arch Phys Med Rehabil. 1995;76:27–32. doi: 10.1016/S0003-9993(95)80038-7.
    1. Lord SE, McPherson K, McNaughton HK, Rochester L, Weatherall M. Community ambulation after stroke: how important and obtainable is it and what measures appear predictive? Arch Phys Med Rehabil. 2004;85:234–239. doi: 10.1016/j.apmr.2003.05.002.
    1. Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005;21:1677–1684.
    1. Dietz V, Muller R, Colombo G. Locomotor activity in spinal man: significance of afferent input from joint and load receptors. Brain. 2002;125:2626–2634. doi: 10.1093/brain/awf273.
    1. Levin MF, Kleim JA, Wolf SL. What do motor "recovery" and "compensation" mean in patients following stroke? Neurorehabil Neural Repair. 2009;23:313–319.
    1. Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004;35:2529–2539. doi: 10.1161/01.STR.0000143153.76460.7d.
    1. Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011;14:1693–1702.
    1. Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009;8:741–754. doi: 10.1016/S1474-4422(09)70150-4.
    1. Stinear C, Ackerley S, Byblow W. Rehabilitation is initiated early after stroke, but most motor rehabilitation trials are not: a systematic review. Stroke. 2013;44:2039–2045. doi: 10.1161/STROKEAHA.113.000968.
    1. Bowden MG, Woodbury ML, Duncan PW. Promoting neuroplasticity and recovery after stroke: future directions for rehabilitation clinical trials. Curr Opin Neurol. 2013;26:37–42. doi: 10.1097/WCO.0b013e32835c5ba0.
    1. Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012;26:923–931. doi: 10.1177/1545968312440745.
    1. Moseley AM, Stark A, Cameron ID, Pollock A. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2005;4 Art. No.: CD002840. DOI: 10.1002/14651858.CD002840.pub2.
    1. Sullivan KJ, Knowlton BJ, Dobkin BH. Step training with body weight support: effect of treadmill speed and practice paradigms on poststroke locomotor recovery. Arch Phys Med Rehabil. 2002;83:683–691. doi: 10.1053/apmr.2002.32488.
    1. Hesse S, Waldner A, Tomelleri C. Innovative gait robot for the repetitive practice of floor walking and stair climbing up and down in stroke patients. J Neuroeng Rehabil. 2010;7:30. doi: 10.1186/1743-0003-7-30.
    1. Jezernik S, Colombo G, Keller T, Frueh H, Morari M. Robotic Orthosis Lokomat: a rehabilitation and research tool. Neuromodulation. 2003;6:108–115. doi: 10.1046/j.1525-1403.2003.03017.x.
    1. Mehrholz J, Elsner B, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2013;7 Art. No.: CD006185. DOI: 10.1002/14651858.CD006185.pub3.
    1. Mehrholz J, Pohl M. Electromechanical-assisted gait training after stroke: a systematic review comparing end-effector and exoskeleton devices. J Rehabil Med. 2012;44:193–199. doi: 10.2340/16501977-0943.
    1. Dobkin BH. Motor rehabilitation after stroke, traumatic brain, and spinal cord injury: common denominators within recent clinical trials. Curr Opin Neurol. 2009;22:563–569. doi: 10.1097/WCO.0b013e3283314b11.
    1. Pennycott A, Wyss D, Vallery H, Klamroth-Marganska V, Riener R. Towards more effective robotic gait training for stroke rehabilitation: a review. J Neuroeng Rehabil. 2012;9:65. doi: 10.1186/1743-0003-9-65.
    1. Hidler J, Nichols D, Pelliccio M, Brady K, Campbell DD, Kahn JH, Hornby TG. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Neurorehabil Neural Repair. 2009;23:5–13.
    1. Lewek MD, Cruz TH, Moore JL, Roth HR, Dhaher YY, Hornby TG. Allowing intralimb kinematic variability during locomotor training poststroke improves kinematic consistency: a subgroup analysis from a randomized clinical trial. Phys Ther. 2009;89:829–839. doi: 10.2522/ptj.20080180.
    1. Schwartz I, Sajin A, Fisher I, Neeb M, Shochina M, Katz-Leurer M, Meiner Z. The effectiveness of locomotor therapy using roboticassisted gait training in subacute stroke patients: a randomized controlled trial. PMR. 2010;1:516–523.
    1. Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoölig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomised multicentre trial (DEutsche GAngtrainerStudie, DEGAS) Clin Rehabil. 2007;21:17–27. doi: 10.1177/0269215506071281.
    1. Coenen P, van Werven G, van Nunen MPM, Van Dieën JH, Gerrits KHL, Janssen TWJ. Robot-assisted walking vs overground walking in stroke patients: an evaluation of muscle activity. J Rehabil Med. 2012;44:331–337. doi: 10.2340/16501977-0954.
    1. Husemann B, Müller 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;38:349–354. doi: 10.1161/01.STR.0000254607.48765.cb.
    1. van Nunen MPM, Gerrits KHL, Konijnenbelt M, Janssen TWJ, de Haan A. Recovery of walking ability using a robotic device in subacute stroke patients: a randomized controlled study. Disabil Rehabil Assist Technol. 2014. pp. 1–8. Early Online.
    1. Krishnan C, Ranganathan R, Kantak SS, Dhaher YY, Rymer WZ. Active robotic training improves locomotor function in a stroke survivor. J Neuroeng Rehabil. 2012;9:57. doi: 10.1186/1743-0003-9-57.
    1. Kawamoto H, Sankai Y. Power assist system HAL-3 for gait disorder person. Berlin Heidelberg: Springer-Verlag; 2002. pp. 196–203. (Lecture Notes in Computer Science, Volume 2398).
    1. Suzuki K, Mito G, Kawamoto H, Hasegawa Y, Sankai Y. Intention-based walking support for paraplegia patients with Robot Suit HAL. Adv Robot. 2007;21:1441–1469.
    1. Kawamoto H, Taal S, Niniss H, Hayashi T, Kamibayashi K, Eguchi K, Sankai Y. Voluntary motion support control of Robot Suit HAL triggered by bioelectrical signal for hemiplegia. Conf Proc IEEE Eng Med Biol Soc. 2010. pp. 462–466.
    1. Kubota S, Nakata Y, Eguchi K, Kawamoto H, Kamibayashi K, Sakane M, Sankai Y, Ochiai N. Feasibility of rehabilitation training with a newly developed wearable robot for patients with limited mobility. Arch Phys Med Rehabil. 2013;94:1080–1087. doi: 10.1016/j.apmr.2012.12.020.
    1. Kawamoto H, Kamibayashi K, Nakata Y, Yamawaki K, Ariyasu R, Sankai Y, Sakane M, Eguchi K, Ochiai N. Pilot study of locomotion improvement using hybrid assistive limb in chronic stroke patients. BMC Neurol. 2013;13:141. doi: 10.1186/1471-2377-13-141.
    1. Ueba T, Hamada O, Ogata T, Inoue T, Shiota E, Sankai Y. Feasibility and safety of acute phase rehabilitation after stroke using the hybrid assistive limb robot suit. Neurol Med Chir. 2013;53:287–290. doi: 10.2176/nmc.53.287.
    1. Kirtley C. Observational gait analysis. 1. Washington: Churchill Livingstone; 2006. pp. 267–298. (Clinical Gait Ananlysis: Theory and Practice).
    1. Lyden P, Brott T, Tilley B, Welch KM, Mascha EJ, Levine S, Haley EC, Grotta J, Marler J. Improved reliability of the NIH stroke scale using video training. NINDS TPA Stroke Study Group. Stroke. 1994;25:2220–2226. doi: 10.1161/01.STR.25.11.2220.
    1. Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. A method for evaluation of physical performance. Scand J Rehabil Med. 1975;7:13–31.
    1. Berg KW-DS, Williams JI, Gayton D. Measuring balance in the enderly: preliminary development of an instrument. Physiother Can. 1989;41:304–311. doi: 10.3138/ptc.41.6.304.
    1. Berg KMB, Williams J, Holliday P, Wood-Dauphinée S. Clinical and laboratory measures of postrural balance in an elderly population. Arch Phys Med Rehabil. 1992;73:1073–1080.
    1. Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142–148.
    1. Wade DT, Wood VA, Heller A, Maggs J, Langton HR. Walking after stroke. Measurement and recovery over the first 3 months. Scand J Rehabil Med. 1987;19:25–30.
    1. Hasselgren-Nyberg L, Omberg M, Nyberg L, Gustafson Y. S-COVS. Den svenska versionen av Physiotherapy clinical outcome variables scale. Nord Fysioter. 1997;1:109–113.
    1. Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984;64:35–40.
    1. Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990;45:239–243. doi: 10.1093/geronj/45.6.P239.
    1. Mahoney FI, Barthel DW. Functional evaluation: the Barthel index. Md State Med J. 1965;14:61–65.
    1. Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6–18.
    1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol group. Ann Med. 2001;33:337–343. doi: 10.3109/07853890109002087.
    1. Duncan PW, Goldstein LB, Horner RD, Landsman PB, Samsa GP, Matchar DB. Similar motor recovery of upper and lower extremities after stroke. Stroke. 1994;25:1181–1188. doi: 10.1161/01.STR.25.6.1181.
    1. Kwakkel G, Kollen B, Twisk J. Impact of time on improvement of outcome after stroke. Stroke. 2006;37:2348–2353. doi: 10.1161/01.STR.0000238594.91938.1e.

Source: PubMed

3
Prenumerera