GAIT TREATMENT WITH WEARABLE CYBORG HYBRID ASSISTIVE LIMB IN PERSONS WITH ACUTE STROKE: A NON-RANDOMIZED CLINICAL TRIAL

H. Watanabe¹, A. Marushima¹, H. Kadone², T. Ueno³, Y. Shimizu³, S. Kubota², T. Hino¹, M. Sato¹, Y. Ito¹, M. Hayakawa¹, H. Tsurushima¹, Y. Hada³, M. Yamazaki², E. Ishikawa¹, Y. Matsumaru¹, A. Matsumura¹

Background: Recent Cochrane Systematic Review 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. Moreover, most benefits were seen in the first 3 months after the stroke and in those unable to walk. There have been a few clinical trials assessing the safety and feasibility of locomotor training using a wearable cyborg Hybrid Assistive Limb (HAL). However, it is still unclear whether gait treatment with HAL benefits persons with acute stroke because the controls have not been used in previous studies. Therefore, we wanted to compare the effects of gait treatment with a single-leg version of HAL against that of conventional gait training (CGT) in persons with acute stroke.

Purpose: We aimed to compare the efficacy of gait treatment using a wearable cyborg single-leg version of HAL on the paretic side with that of CGT in persons with acute stroke.

Methods: Subjects admitted to the participating university hospital were assigned to the HAL group, whereas those admitted outside of teaching hospitals under the same rehabilitation program who did not use the HAL were assigned to the CGT group. Twenty-four persons with stroke (13 persons allocated to the HAL group, one withdrew consent, and 11 persons allocated to the CGT group, one dropped out) participated in this study. Participants in the HAL group received gait treatment with HAL, whereas those in the CGT group received gait training without HAL. Intervention was performed 3 times a week for a total of 9 times for 3 weeks. Outcome measures were evaluated prior to training after the 3rd, 6th, and 9th sessions. The functional ambulation category (FAC) was the primary outcome measure, whereas comfortable walking speed (CWS), step length (SL), cadence, 6-min walking distance (6MWD), Barthel Index (BI), Functional Independence Measure (FIM) and Fugl–Meyer assessment of lower extremity (FMA-LE) were secondary outcome measures.

Results: Twenty-two persons with stroke completed this study. No serious adverse events occurred in either group. Participants who received gait treatment with HAL showed significant improvement in FAC after 9 sessions than those who received CGT (p < 0.05). In the weekly change in FAC, the HAL group showed a pattern of recovery earlier than the CGT group, showing a significant interaction (p < 0.01). However, the amount of change in the secondary outcome measures did not differ significantly between the two groups, with both groups experiencing significant improvements in FAC, CWS, SL, cadence, 6MWD, BI, FIM (total and motor scores), and FMA-LE (p < 0.05).

Conclusion(s): The results obtained in this non-randomized clinical trial suggest that HAL-based gait treatment may improve independent walking in persons 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 treatment.

Implications: Incorporation of HAL-based gait treatment into inpatient rehabilitation programs may benefit to improve independent walking in persons with acute stroke.

Funding, acknowledgements: This study was supported by the JSPS KAKENHI Grant Number JP19K19788.

Keywords: Hybrid Assistive Limb, Robotics, Independent Walking

Topic: Innovative technology: robotics

Did this work require ethics approval? Yes

Institution: University of Tsukuba

Committee: The Ethics Committee of the University of Tsukuba Hospital

Ethics number: H27-257