Randomized controlled trial of robot-assisted gait training with dorsiflexion assistance on chronic stroke patients wearing ankle-foot-orthosis

Ling-Fung Yeung, Corinna Ockenfeld, Man-Kit Pang, Hon-Wah Wai, Oi-Yan Soo, Sheung-Wai Li, Kai-Yu Tong, Ling-Fung Yeung, Corinna Ockenfeld, Man-Kit Pang, Hon-Wah Wai, Oi-Yan Soo, Sheung-Wai Li, Kai-Yu Tong

Abstract

Background: Robot-assisted ankle-foot-orthosis (AFO) can provide immediate powered ankle assistance in post-stroke gait training. Our research team has developed a novel lightweight portable robot-assisted AFO which is capable of detecting walking intentions using sensor feedback of wearer's gait pattern. This study aims to investigate the therapeutic effects of robot-assisted gait training with ankle dorsiflexion assistance.

Methods: This was a double-blinded randomized controlled trial. Nineteen chronic stroke patients with motor impairment at ankle participated in 20-session robot-assisted gait training for about five weeks, with 30-min over-ground walking and stair ambulation practices. Robot-assisted AFO either provided active powered ankle assistance during swing phase in Robotic Group (n = 9), or torque impedance at ankle joint as passive AFO in Sham Group (n = 10). Functional assessments were performed before and after the 20-session gait training with 3-month Follow-up. Primary outcome measure was gait independency assessed by Functional Ambulatory Category (FAC). Secondary outcome measures were clinical scores including Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), Berg Balance Scale (BBS), Timed 10-Meter Walk Test (10MWT), Six-minute Walk Test (SMWT), supplemented by gait analysis. All outcome measures were performed in unassisted gait after patients had taken off the robot-assisted AFO. Repeated-measures analysis of covariance was conducted to test the group differences referenced to clinical scores before training.

Results: After 20-session robot-assisted gait training with ankle dorsiflexion assistance, the active ankle assistance in Robotic Group induced changes in gait pattern with improved gait independency (all patients FAC ≥ 5 post-training and 3-month follow-up), motor recovery, walking speed, and greater confidence in affected side loading response (vertical ground reaction force + 1.49 N/kg, peak braking force + 0.24 N/kg) with heel strike instead of flat foot touch-down at initial contact (foot tilting + 1.91°). Sham Group reported reduction in affected leg range of motion (ankle dorsiflexion - 2.36° and knee flexion - 8.48°) during swing.

Conclusions: Robot-assisted gait training with ankle dorsiflexion assistance could improve gait independency and help stroke patients developing confidence in weight acceptance, but future development of robot-assisted AFO should consider more lightweight and custom-fit design.

Trial registration: ClinicalTrials.gov NCT02471248 . Registered 15 June 2015 retrospectively registered.

Keywords: Ankle foot orthosis; Exoskeletons; Gait training; Robotics; Stroke.

Conflict of interest statement

Ethics approval and consent to participate

The study is approved by The Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC) (CRE Ref. no. 2015.037-T). This RCT was designed following the principle of the Declaration of Helsinki. Written consent to participate in the experiment were obtained from all subjects recruited.

Consent for publication

The people with stroke in Fig. 1 have consented to the publication of the photograph.

Competing interests

Yeung LF, Ockenfeld C, Pang MK, Wai HW, and Tong KY are co-inventors of the Hong Kong Polytechnic University-held patent for the robot-assisted AFO used in this study. All authors, however, are of no financial relationship whatsoever for the submitted work with Rehab-Robotics Company Ltd., the company under license agreement with the University.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
a Robot-assisted AFO, and b Stroke patients walking on stairs wearing the robot-assisted AFO
Fig. 2
Fig. 2
CONSORT patient flow diagram
Fig. 3
Fig. 3
Percentage changes (mean ± SD) in (a) walking distance and (b) stairs covered across gait training sessions, normalized to the first session (Baseline)
Fig. 4
Fig. 4
Foot tilting angle from the ground after gait training. Robotic Group (red) had positive tilting angle at initial contact for heel strike, while Sham Group (dark) used flat foot contact during weight acceptance (0–20% gait cycle). Foot tilting angle of Sham Group remained negative after mid-swing indicates foot drop abnormality

References

    1. Jang SH. The recovery of walking in stroke patients: a review. Int J Rehabil Res. 2010;33:285–289. doi: 10.1097/MRR.0b013e32833f0500.
    1. Beyaert C, Vasa R, Frykberg GE. Gait post-stroke: pathophysiology and rehabilitation strategies. Neurophysiol Clin. 2015;45:335–355. doi: 10.1016/j.neucli.2015.09.005.
    1. Kitatani R, Ohata K, Aga Y, et al. Descending neural drives to ankle muscles during gait and their relationships with clinical functions in patients after stroke. Clin Neurophysiol. 2016;127:1512–1520. doi: 10.1016/j.clinph.2015.10.043.
    1. Moore S, Schurr K, Wales A, Moseley A, Herbert R. Observation and analysis of hemiplegic gait: swing phase. Aust J Physiother. 1993;39:271–278. doi: 10.1016/S0004-9514(14)60487-6.
    1. Dubin A. Gait: the role of the ankle and foot in walking. Med Clin North Am. 2014;98:205–211. doi: 10.1016/j.mcna.2013.10.002.
    1. Kim J, Oh S-I, Cho H, Kim HS, Chon J, Lee WJ, et al. Gait patterns of chronic ambulatory hemiplegic elderly compared with normal age-matched elderly. Int J Precis Eng Manuf. 2015;16:385–392. doi: 10.1007/s12541-015-0051-z.
    1. Woolley SM. Characteristics of gait in hemiplegia. Top Stroke Rehabil. 2001;7:1–18. doi: 10.1310/JB16-V04F-JAL5-H1UV.
    1. Lauziere S, Betschart M, Aissaoui R, Nadeau S. Understanding spatial and temporal gait asymmetries in individuals post stroke. Int J Phys Med Rehabil. 2014;2:201.
    1. Weerdesteyn V, de Niet M, van Duijnhoven HJR, Geurts ACH. Falls in individuals with stroke. J Rehabil Res Dev. 2008;45:1195. doi: 10.1682/JRRD.2007.09.0145.
    1. Burpee JL, Lewek MD. Biomechanical gait characteristics of naturally occurring unsuccessful foot clearance during swing in individuals with chronic stroke. Clin Biomech. 2015;30:1102–1107. doi: 10.1016/j.clinbiomech.2015.08.018.
    1. Kramer S, Johnson L, Bernhardt J, Cumming T. Energy expenditure and cost during walking after stroke: a systematic review. Arch Phys Med Rehabil. 2016;97:619–632. doi: 10.1016/j.apmr.2015.11.007.
    1. Franceschini M, Rampello A, Agosti M, Massucci M, Bovolenta F, Sale P. Walking performance: correlation between energy cost of walking and walking participation. New statistical approach concerning outcome measurement. PLoS One. 2013;8:e56669. doi: 10.1371/journal.pone.0056669.
    1. Tyson SF, Sadeghi-Demneh E, Nester CJ. A systematic review and meta-analysis of the effect of an ankle-foot orthosis on gait biomechanics after stroke. Clin Rehabil. 2013;27:879–891. doi: 10.1177/0269215513486497.
    1. Tyson SF, Kent RM. Effects of an ankle-foot orthosis on balance and walking after stroke: a systematic review and pooled meta-analysis. Arch Phys Med Rehabil. 2013;94:1377–1385. doi: 10.1016/j.apmr.2012.12.025.
    1. Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy T, Brandstater M, et al. Long-term follow-up to a randomized controlled trial comparing peroneal nerve functional electrical stimulation to an ankle foot orthosis for patients with chronic stroke. Neurorehab Neural Repair. 2015;29:911–922. doi: 10.1177/1545968315570325.
    1. Dollar AM, Herr H. Lower extremity exoskeletons and active orthoses: challenges and state-of-the-art. IEEE Trans Robot. 2008;24:144–158. doi: 10.1109/TRO.2008.915453.
    1. Shorter KA, Xia J, Hsiao-Wecksler ET, Durfee WK, Kogler GF. Technologies for powered ankle-foot orthotic systems: possibilities and challenges. IEEE/ASME Trans Mechatron. 2013;18:337–347. doi: 10.1109/TMECH.2011.2174799.
    1. Alam M, Choudhury IA, Bin Mamat A. Mechanism and design analysis of articulated ankle foot orthoses for drop-foot. Sci World J. 2014;2014:867869.
    1. Blaya JA, Herr H. Adaptive control of a variable-impedance ankle-foot orthosis to assist drop-foot gait. IEEE Trans Neural Syst Rehab Eng. 2004;12:24–31. doi: 10.1109/TNSRE.2003.823266.
    1. Ward J, Sugar T, Standeven J, Engsberg JR. Robotics and Automation 2010 IEEE International Conference. 2010. Stroke survivor gait adaptation and performance after training on a powered ankle foot orthosis; pp. 211–216.
    1. Kreisel SH, Hennerici MG, Bäzner H. Pathophysiology of stroke rehabilitation: the natural course of clinical recovery, use-dependent plasticity and rehabilitative outcome. Cerebrovasc Dis. 2007;23:243–255. doi: 10.1159/000098323.
    1. Kleim JA, Jones TA. Principles of experience-dependent neural plasticity: implications for rehabilitation after brain damage. J Speech Lang Hear Res. 2008;51:S225–S239. doi: 10.1044/1092-4388(2008/018).
    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. Thomas LH, French B, Coupe J, McMahon N, Connell L, Harrison J, et al. Repetitive task training for improving functional ability after stroke: a major update of a Cochrane review. Stroke. 2017;48:e102–e103. doi: 10.1161/STROKEAHA.117.016503.
    1. Forrester LW, Roy A, Krebs HI, Macko RF. Ankle training with a robotic device improves hemiparetic gait after a stroke. Neurorehabl Neural Re. 2011;25:369–377. doi: 10.1177/1545968310388291.
    1. Perez MA, Lungholt BK, Nyborg K, Nielsen JB. Motor skill training induces changes in the excitability of the leg cortical area in healthy humans. Exp Brain Res. 2004;159:197–205. doi: 10.1007/s00221-004-1947-5.
    1. Salbach NM, Mayo NE, Wood-Dauphinee S, Hanley JA, Richards CL, Côté R. A task-orientated intervention enhances walking distance and speed in the first year post stroke: a randomized controlled trial. Clin Rehabil. 2004;18(5):509–519. doi: 10.1191/0269215504cr763oa.
    1. Tucker MR, Olivier J, Pagel A, Bleuler H, Bouri M, Lambercy O, et al. Control strategies for active lower extremity prosthetics and orthotics: a review. J Neuroeng Rehabil. 2015;12(1)
    1. Lo AC. Clinical designs of recent robot rehabilitation trials. Am J Phys Med Rehabil. 2012;91:S204–S216. doi: 10.1097/PHM.0b013e31826bcfa3.
    1. Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2017;5:CD006185.
    1. Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007;88(10):1314–1319. doi: 10.1016/j.apmr.2007.06.764.
    1. Yeung LF, Ockenfeld C, Pang MK, Wai HW, Soo OY, Li SW, et al. Design of an exoskeleton ankle robot for robot-assisted gait training of stroke patients. IEEE Int Conf Rehabil Robot. 2017;2017:211–215.
    1. Riener R, Rabuffetti M, Frigo C. Stair ascent and descent at different inclinations. Gait Posture. 2002;15(1):32–44. doi: 10.1016/S0966-6362(01)00162-X.
    1. Geroin C, Mazzoleni S, Smania N, Gandolfi M, Bonaiuti D, Gasperini G, et al. Systematic review of outcome measures of walking training using electromechanical and robotic devices in patients with stroke. J Rehabil Med. 2013;45:987–996. doi: 10.2340/16501977-1234.
    1. Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom clinical research network database. BMC Med Res Methodol. 2013;13:104. doi: 10.1186/1471-2288-13-104.
    1. Lotze M, Braun C, Birbaumer N, Anders S, Cohen LG. Motor learning elicited by voluntary drive. Brain. 2003;126:866–872. doi: 10.1093/brain/awg079.
    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. Tang A, Eng JJ, Rand D. Relationship between perceived and measured changes in walking after stroke. J Neurol Phys Ther. 2012;36:115–121. doi: 10.1097/NPT.0b013e318262dbd0.
    1. Bortole M, Venkatakrishnan A, Zhu F, Moreno JC, Francisco GE, Pons JL, et al. The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. J Neuroeng Rehabil. 2015;12:54. doi: 10.1186/s12984-015-0048-y.
    1. Perry J, Garrett M, Gronley JK, Mulroy SJ. Classification of walking handicap in the stroke population. Stroke. 1995;26:982–989. doi: 10.1161/01.STR.26.6.982.
    1. Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006;54:743–749. doi: 10.1111/j.1532-5415.2006.00701.x.
    1. Pandian S, Arya KN, Kumar D. Minimal clinically important difference of the lower-extremity fugl-meyer assessment in chronic-stroke. Top Stroke Rehabil. 2016;23:233–239. doi: 10.1179/1945511915Y.0000000003.
    1. Lewek MD, Randall EP. Reliability of spatiotemporal asymmetry during overground walking for individuals following chronic stroke. J Neurol Phys Ther. 2011;35:116–121. doi: 10.1097/NPT.0b013e318227fe70.
    1. Sheffler LR, Taylor PN, Gunzler DD, Buurke JH, Ijzerman MJ, Chae J. Randomized controlled trial of surface peroneal nerve stimulation for motor relearning in lower limb hemiparesis. Arch Phys Med Rehabil. 2013;94:1007–1014. doi: 10.1016/j.apmr.2013.01.024.
    1. Stansfield BW, Hillman SJ, Hazlewood ME, Lawson AA, Mann AM, Loudon IR, et al. Normalized speed, not age, characterizes ground reaction force patterns in 5-to 12-year-old children walking at self-selected speeds. J Pediatr Orthop. 2001;21:395–402.
    1. Rossi S, Colazza A, Petrarca M, Castelli E, Cappa P, Krebs HI. Feasibility study of a wearable exoskeleton for children: is the gait altered by adding masses on lower limbs? PLoS One. 2013;8:e73139. doi: 10.1371/journal.pone.0073139.
    1. Khanna I, Roy A, Rodgers MM, Krebs HI, Macko RM, Forrester LW. Effects of unilateral robotic limb loading on gait characteristics in subjects with chronic stroke. J Neuroeng Rehab. 2010;7(1)
    1. Browning RC, Modica JR, Kram R, Goswami A. The effects of adding mass to the legs on the energetics and biomechanics of walking. Med Sci Sports Exerc. 2007;39:515–525. doi: 10.1249/mss.0b013e31802b3562.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe