Effects of Gait Treatment With a Single-Leg Hybrid Assistive Limb System After Acute Stroke: A Non-randomized Clinical Trial.

Hiroki Watanabe,Hideo Tsurushima,Masayuki Sato,Hiroyuki Fujimori,Akira Matsumura,Tenyu Hino,Yuji Matsumaru,Tomoya Takada,Yoshiyuki Sankai,Yasushi Hada,Atsuro Tsukada,Aiki Marushima,Kazushi Maruo,Yoshiro Ito,Hideki Kadone,Hiroaki Kawamoto,Eiichi Ishikawa,Masashi Yamazaki,Tomoyuki Ueno,Nobuko Sato ,Shigeki Kuzuhara ,Masayuki Hayakawa ,Yoshiki Shimizu

doi:10.3389/fnins.2019.01389

Abstract

We hypothesized that a single-leg version of the Hybrid Assistive Limb (HAL) system could improve the gait and physical function of patients with hemiparesis following a stroke. In this pilot study, we therefore compared the efficacy of HAL-based gait training with that of conventional gait training (CGT) in patients with acute stroke. Patients admitted to the participating university hospital were assigned to the HAL group, whereas those admitted to outside teaching hospitals under the same rehabilitation program who did not use the HAL were assigned to the control group. Over 3 weeks, all participants completed nine 20 min sessions of gait training, using either HAL (i.e., the single-leg version of HAL on the paretic side) or conventional methods (i.e., walking aids and gait orthoses). Outcome measures were evaluated before and after the nine training sessions. The Functional Ambulation Category (FAC) was the primary outcome measure, but the following secondary outcome measures were also assessed: National Institutes of Health Stroke Scale, Fugl–Meyer Assessment (Lower Extremity), comfortable walking speed, step length, cadence, 6-min walk distance, Barthel Index, and Functional Independence Measure. In total, 22 post-stroke participants completed the clinical trial: 12 in the HAL group and 10 in the CGT group. No serious adverse events occurred in either group. The HAL group showed significant improvement in FAC after nine sessions when compared with the CGT group (P = 0.014). However, secondary outcomes did not differ significantly between the groups. Our results demonstrate that HAL-based gait therapy may improve independent walking in patients with acute stroke hemiplegia who are dependent on ambulatory assistance. A larger-scale randomized controlled trial is needed to clarify the effectiveness of single-leg HAL therapy.Clinical Trial Registration: UMIN Clinical Trials Registry, identifier UMIN000022410.

Highlights

Stroke is a serious and disabling health problem that is common worldwide (Langhorne et al, 2011)
Our results demonstrate that Hybrid Assistive Limb (HAL)-based gait therapy may improve independent walking in patients with acute stroke hemiplegia who are dependent on ambulatory assistance
A recent systematic review of the Cochrane database suggested that electromechanical-assisted gait training in combination with physiotherapy was more likely to produce independent walking after a stroke than gait training without these devices

Summary

Introduction

Stroke is a serious and disabling health problem that is common worldwide (Langhorne et al, 2011). 90% of patients who suffer a stroke will have persistent neurological motor deficits that cause disability and handicap (Hesse and Werner, 2003). The recovery of gait and independent walking are common goals following a major stroke (Dobkin, 2005; Peurala et al, 2009), and the intensity of rehabilitation therapy for the arms and legs is known to be positively correlated with motor outcomes after stroke (Kwakkel et al, 1999). Given that the recovery of walking function mainly occurs within the first 11 weeks after a stroke (Jørgensen et al, 1995), active and intensive gait treatment should start from the acute stage. Most benefit was seen in the first 3 months after stroke and in those unable to walk (Mehrholz et al, 2017)

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Results

Conclusion