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

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

doi:10.3389/fnins.2019.01389

Cited by 14 publications

(24 citation statements)

References 44 publications

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“…Several studies on HAL treatment use different evaluation parameters, such as improvement of independent walking for acute stroke, improvement of activities of daily living for subacute stroke, improvement of spatiotemporal gait parameters for chronic stroke, improvement of health-related quality of life for chronic spinal cord injury, and a decrease of spasticity for chronic spinal cord injury 17,18,[26][27][28] .…”

Section: Discussionmentioning

confidence: 99%

“…2 and 3). It is presumed that these are the results of appropriate walking support by cybernetic control and securing of repeated walking amount 18,[38][39][40] . Although many clinical studies have been conducted in the last decade, more clinical studies, particularly high-quality design studies, are needed to elucidate the mechanism of HAL treatment.…”

Section: Discussionmentioning

confidence: 99%

“…In the last decade, gait treatment using a wearable cyborg hybrid assisted limb (HAL) has been promoted in the stroke rehabilitation field. Such a treatment has significantly improved the independent walking, gait speed, gait endurance, and gait posture of stroke patients [15][16][17][18] .…”

Section: Introductionmentioning

confidence: 99%

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Effect of hybrid assistive limb treatment on maximal walking speed and six-minute walking distance during stroke rehabilitation: a pilot study

2021

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In stroke rehabilitation, gait assessment measures the maximal walking speed and six-minute walking distance, both of which have not been thoroughly investigated as determinants of walking ability. Here, we assessed the methods for evaluating these gait parameters using clinical data on hybrid assistive limb treatment compared with conventional training. [Participants and Methods] In total, 20 stroke patients (hybrid assistive limb group, n=9; conventional group, n=11) participated in this randomized controlled trial. For 12 sessions (three times per week in 4 weeks), the hybrid assistive limb and conventional groups performed gait treatment with hybrid assistive limb and conventional gait training, respectively. Short physical performance battery and walking ability (maximal walking speed and six-minute walking distance) were evaluated pre-and post-intervention. Subsequently, the patients were divided further into two groups: low-and high-balance score groups. [Results] Maximum walking speed and six-minute walking distance were significantly associated, with a positive relationship observed postintervention. The high-balance score group showed a significant improvement in the six-minute walking distance compared to the low-balance score group. However, no significant improvement in maximum walking speed was observed between both groups. [Conclusion] Due to its sensitivity in detecting differences in balance, six-minute walking distance may be a useful assessment parameter for stroke rehabilitation, particularly in the recovery of physiological walking ability.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Effect of hybrid assistive limb treatment on maximal walking speed and six-minute walking distance during stroke rehabilitation: a pilot study

2021

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“…The results of our previous non-randomized clinical trial suggested that the HAL treatment group showed a significant improvement in FAC after nine sessions compared with the conventional treatment group (Watanabe et al, 2020). Furthermore, examination of changes in FAC on a weekly basis revealed a significant group × time point interaction in FAC of the HAL treatment group, suggesting that independent walking may be improved at an early stage [unpublished data].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety Study of Wearable Cyborg HAL (Hybrid Assistive Limb) in Hemiplegic Patients With Acute Stroke (EARLY GAIT Study): Protocols for a Randomized Controlled Trial

et al. 2021

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We hypothesized that gait treatment with a wearable cyborg Hybrid Assistive Limb (HAL) would improve the walking ability of patients with hemiparesis after stroke. This study aims to evaluate the efficacy and safety of gait treatment using HAL versus conventional gait training (CGT) in hemiplegic patients with acute stroke and establish a protocol for doctor-initiated clinical trials for acute stroke. We will enroll patients with acute stroke at the University of Tsukuba Hospital. This study is a single-center, randomized, parallel-group, controlled trial (HAL group, n = 20; control group, n = 20) that will include three phases: (1) pre-observation phase (patient enrollment, baseline assessment, and randomization); (2) treatment phase (nine sessions, twice or thrice per week over 3−4 weeks; the HAL and control groups will perform gait treatment using HAL or CGT, respectively, and finally (3) post-treatment evaluation phase. The Functional Ambulation Category score will be the primary outcome measure, and the following secondary outcome measures will be assessed: Mini-Mental State Examination, Brunnstrom recovery stage of lower limbs, Fugl–Meyer assessment of lower limbs, 6-min walking distance, comfortable gait speed, step length, cadence, Barthel Index, Functional Independence Measure, gait posture, motion analysis (muscle activity), amount of activity (evaluated using an activity meter), stroke-specific QOL, and modified Rankin Scale score. The baseline assessment, post-treatment evaluation, and follow-up assessment will evaluate the overall outcome measures; for other evaluations, physical function evaluation centered on walking will be performed exclusively, excluding ADL and QOL scores. This study is a randomized controlled trial that aims to clarify the efficacy and safety of gait treatment using HAL compared with CGT in hemiplegic patients with acute stroke. In addition, we aim to establish a protocol for doctor-initiated clinical trials for acute stroke based on the study results. If our results demonstrate the effectiveness of the proposed treatment regarding outcomes of patients with hemiplegic acute stroke, this study will promote the treatment of these patients using the HAL system as an effective tool in future stroke rehabilitation programs. The study protocol was registered with the Japan Registry of Clinical Trials on October 14, 2020 (jRCTs032200151).

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“…To date, several types of HAL (HAL for lower limbs and HAL for single joints) have been applied for several musculoskeletal and neurological disorders [ 10 – 14 ]. It has been reported that the lower limb type HAL, which can assist hip and knee joint motion, might improve gait function for myelopathy [ 10 ], cerebral infarction [ 11 ], and cerebral palsy [ 12 ]. The single-joint type HAL can assist knee and elbow joint motion.…”

Section: Introductionmentioning

confidence: 99%

Exercise training using hybrid assistive limb (HAL) lumbar type for locomotive syndrome: a pilot study

Miura

Koda

Tamaki

et al. 2021

BMC Musculoskelet Disord

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Background With a rapidly aging population in Japan, locomotive syndrome is becoming an increasingly serious social problem. Exercise therapy using the lumbar type HAL, which is a wearable robot suit that can assist voluntary hip joint motion, would be expected to cause some beneficial effects for people with locomotive syndrome. The purpose of this study was to assess whether the deterioration of low back pain and any other adverse events would occur following HAL exercise therapy. Moreover, the changes of motor ability variables were evaluated. Methods We enrolled 33 participants (16 men, 17 women) with locomotive syndrome in this study. They received exercise training (sit-to-stand, lumbar flexion-extension, and gait training) with HAL (in total 12 sessions). We assessed the change of low back pain (lumbar VAS). More than 50% and 25 mm increase compared to baseline was defined as adverse events. One-leg standing time (OLST), 10-m walking test (10MWT), Timed Up and Go test (TUG), 1-min sit-to-stand test (1MSTS), FIM mobility scores and EQ-5D were measured. Results Of the 33 participants, 32 (16 men, 16 women) (97.0%) completed all 12 exercise training sessions using the lumbar type HAL. One woman aged 82 years withdrew because of right upper limb pain after the second session regardless of the use of HAL. There was no participant who had deterioration of low back pain. Any other adverse events including external injuries and/or falling, skin disorders, uncontrollable cardiovascular or respiratory disorders, and other health disorders directly related to this exercise therapy did not occur. Several outcome measures of motion ability including OLST, TUG and 1MSTS, EQ VAS and lumbar pain improved significantly after this HAL training. Conclusions Almost all patients with locomotive syndrome completed this exercise training protocol without any adverse events related to HAL. Furthermore, balance function variables including OLST, TUG and 1MSTS improved after this HAL exercise therapy even though mobility function variables including 10MWT and FIM mobility scores did not show any significant change. These findings suggest that the exercise therapy using the lumbar type HAL would be one of the options for the intervention in locomotive syndrome.

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

Cited by 14 publications

References 44 publications

Effect of hybrid assistive limb treatment on maximal walking speed and six-minute walking distance during stroke rehabilitation: a pilot study

Effect of hybrid assistive limb treatment on maximal walking speed and six-minute walking distance during stroke rehabilitation: a pilot study

Efficacy and Safety Study of Wearable Cyborg HAL (Hybrid Assistive Limb) in Hemiplegic Patients With Acute Stroke (EARLY GAIT Study): Protocols for a Randomized Controlled Trial

Exercise training using hybrid assistive limb (HAL) lumbar type for locomotive syndrome: a pilot study

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