Staged treatment protocol for gait with hybrid assistive limb in the acute phase of patients with stroke

ABSTRACT

Hybrid Assistive Limb (HAL) is a wearable human assistant cyborg-type robot that helps lower-leg movement based on bioelectrical signals detected from the voluntary movement of the person wearing it. In this study, we developed a novel staged HAL treatment protocol for patients with acute stroke. The Regain Program for Gait with HAL (RPG-HAL) was formulated in four steps, based on the severity of limb paralysis. Twenty-one patients with acute stroke received a combination treatment of RPG-HAL and conventional rehabilitation. The feasibility and safety of RPG-HAL were evaluated based on changes in physical function and activities of daily living (ADL). RPG-HAL yielded improvement in gait speed, cadence, step length, and functional ambulation category (FAC). The effect size was >0.8 in all measurements. FAC (1.90) and Barthel Index (BI) (1.92) exhibited the highest scores. Twelve out of 14 patients with FAC 0 before RPG-HAL reached the upper FAC. Thus, earlier intervention using RPG-HAL as improving physical function, ADL, and gait ability in patients with stroke.

KEYWORDS:

• gait treatment
• hybrid assistive limb
• stroke

Acknowledgments

We would like to thank Mayuko Sakamaki, and Yumiko Ito, Center for Innovative Medicine and Engineering (CIME), University of Tsukuba Hospital, for their excellent technical assistance. The authors would like to thank Enago (www.enago.jp) for the English language review.

Declaration of interest

A commercial party having a direct financial interest in the results of the research supporting this article has conferred or will confer a financial benefit on 1 or more of the authors. Y.Sa is the CEO of Cyberdyne Inc, Ibaraki, Japan. H.Kaw is a board member and stockholder of the company. Cyberdyne is the manufacturer of the robot suit HAL. This study was proposed by the authors. Cyberdyne was not directly involved in the study design; collection, analysis, or interpretation of data; writing the report; or the decision to submit the paper for publication. No commercial party with a direct financial interest in the results of this article confer a benefit on the remaining authors (T.U, A.M, Y.Sh, H.W, H.Kad, K.H, S.Y. A.E, Y.H, H.T, E.I, M.Y, and A.M).

Additional information

Funding

This work was supported by the Industrial Disease Clinical Research Grants of the Ministry of Health Labour and Welfare, Japan [No. 14060101-01], Grant-in-Aid for Scientific Research(B), [No. 18H01403], and AMED under Grant Number [19hk0102065h0001].