Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial

Hideo Tsurushima; Masafumi Mizukami; Kenichi Yoshikawa; Tomoyuki Ueno; Yasushi Hada; Masahiko Gosho; Yutaka Kohno; Koichi Hashimoto; Yuichi Iizumi; Toshihiro Kikuchi; Akira Matsumura; Hit2016 Study Group

doi:10.2196/14001

Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial

JMIR Res Protoc. 2019 Oct 11;8(10):e14001. doi: 10.2196/14001.

Collaborators

Hit2016 Study Group:
Hideaki Taki, Hiroaki Yamamura, Keiji Yamaguchi, Koichi Ohnaka, Makiko Seto, Naohisa Kikuchi, Nobuyuki Irie, Takaaki Chin, Takashi Nakajima, Tooru Inoue, Aiki Marushima, Yoshiaki Kin, Yusuke Fujiwara, Yutaka Kohno, Yutaka Yamaguchi

Affiliations

¹ Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
² Department of Physical Therapy, Ibaraki Prefectural University of Health Sciences Hospital, Ami, Japan.
³ Department of of Biostatistics, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
⁴ Tsukuba Clinical Research & Development Organization, University of Tsukuba, Tsukuba, Japan.

PMID: 31605515
PMCID: PMC6913690
DOI: 10.2196/14001

Abstract

Background: Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration.

Objective: This study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation.

Methods: This is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes preintervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and postintervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for preintervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly assessments using the 10-meter maximum walking speed [MWS] test). Patients with an MWS of 30-60 m/minute and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary outcome is the change in MWS from baseline to the end of the 5-week intervention.

Results: This study began in November 2016 and is being conducted at 15 participating facilities in Japan.

Conclusions: Assessments of walking ability vary greatly and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce added recovery of walking ability, which would promote the use of HAL technology in the clinical setting.

Trial registration: UMIN Clinical Trials Registry UMIN000024805; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545.

Keywords: Hybrid Assistive Limb (HAL); gait training; hemiparesis; stroke.

©Hideo Tsurushima, Masafumi Mizukami, Kenichi Yoshikawa, Tomoyuki Ueno, Yasushi Hada, Masahiko Gosho, Yutaka Kohno, Koichi Hashimoto, Yuichi Iizumi, Toshihiro Kikuchi, Akira Matsumura, Hit2016 Study Group. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.10.2019.