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Journal of Physical Therapy Science logoLink to Journal of Physical Therapy Science
. 2025 Mar 1;37(3):126–133. doi: 10.1589/jpts.37.126

Early rehabilitation with lumbar-type hybrid assistive limb for acute stroke patients: a pilot study and clinical review

Takafumi Kobayashi 1,2, Takashi Tsujiuchi 1, Ayako Motomura 2, Takafumi Sagisaka 2, Hayato Asai 1, Yoshino Ueki 2,*
PMCID: PMC11872177  PMID: 40034552

Abstract

[Purpose] To examine the impacts of using lumbar-type hybrid assistive limbs during the acute stage of stroke, specifically on motor function involving the trunk and activities of daily living, as compared to conventional physical therapy. [Participants and Methods] This was a single-center randomized controlled trial. Participants were randomly assigned to either the hybrid assistive limb or conventional physical therapy groups and underwent early rehabilitation with and without hybrid assistive limb training for ten 40-minute sessions over 10 days. Motor functions, including trunk function and activities of daily living, were evaluated before and immediately after the rehabilitation. [Results] Fifteen patients (median age, 67 years; hybrid assistive limb, n=7; conventional physical therapy, n=8) completed the study. No adverse events were observed. After training, both groups exhibited significant improvements on Berg Balance Scale, Functional Independence Measure-total, Functional Independence Measure-motor, and Stroke Impairment Assessment Set-motor scores. The conventional physical therapy group further exhibited significant enhancement in the Functional Independence Measure-cognitive and Functional Ambulation Category. The degree of improvement on the Berg Balance Scale was significantly larger in the hybrid assistive limb group than in the conventional physical therapy group. [Conclusion] Early rehabilitation using lumbar-type hybrid assistive limbs can improve trunk function in the early stages of stroke more than conventional physical therapy and may enhance walking ability and activities of daily living.

Keywords: Rehabilitation, Postural balance, Hybrid assistive limb (HAL)

INTRODUCTION

The incidence of stroke in Japan is higher than that in Western countries1), and stroke is the fourth leading cause of death2). Current treatments for stroke include anticoagulants, thrombectomy, tissue plasminogen activator therapy, and rehabilitation3). After a stroke, various symptoms such as hemiplegia, higher brain dysfunction, speech disorders, and swallowing disorders significantly affect the quality of life. Moreover, stroke is the leading cause of bedridden patients in Japan4). To improve activities of daily living (ADLs) and facilitate early social reintegration, active engagement in rehabilitation therapy within 24–48 h after onset with adequate risk management is strongly recommended5).

Reacquiring walking ability after a stroke not only reduces the burden on caregivers6, 7) but also impacts the prognosis after onset8). Trunk function is crucial for walking reacquisition9, 10), and patients with better sitting balance in the acute phase show improved walking and ADLs in the future11, 12). However, previous studies on early rehabilitation focusing on trunk dysfunction in patients with stroke are limited13, 14).

Recently, rehabilitation robots designed to support exercise training have been introduced and are anticipated to become widespread. These robots are already utilized in the treatment of walking disorders associated with neurodegenerative diseases, strokes, and spinal cord injuries, demonstrating improvements in walking function15, 16). The Hybrid Assistive Limb (HAL; CYBERDYNE, Tsukuba, Japan) is the world’s first wearable cyborg device that supports, improves, and expands the physical functions of the wearer by detecting bioelectrical signals (BES) on the skin surface when the wearer tries to generate muscle force17). The effectiveness of the lower limb-type HAL in patients with acute stroke has already been established18,19,20,21,22,23,24,25). The lower limb-type requires wearing it on the entire lower limb, with multiple sensors and actuators on the waist, knees, and ankles, making it slightly complicated to wear; moreover, the fixation and adjustment of each part take time. To solve this problem, one of the products that applies this technology is the lumbar-type HAL, which has a relatively simple structure, fewer parts, and is easy to wear.

In previous studies using the lumbar-type HAL for patients with Parkinson’s disease and frailty, significant improvements in motor and sensory functions, including the 10-m walk test, stride length, timed up-and-go test (TUG), 30-s chair stand test (CS-30), and visual analog scale, were observed after performing 20–30 min of exercise five times26). In studies using the lumbar-type HAL in patients with chronic heart failure, significant improvements in B-type natriuretic peptide, Short Physical Performance Battery, 6-min walk distance, and isometric knee extension strength were observed after performing sit-to-stand exercises for 5–30 min a day for five days, with a slight improvement in the CS-30 score27). In studies using the lumbar-type HAL for patients after hip surgery, significant improvements in the five-times sit-to-stand test and TUG were observed after performing 15-min sessions six times a week. However, to date, the effects of the lumbar-type HAL on motor function and ADLs in patients with acute stroke have not been reported28).

Therefore, the present study aimed to investigate the rehabilitation effect of the lumbar-type HAL in the acute stage of stroke compared with conventional physical therapy (CPT) on motor function, particularly trunk function and ADLs, using a randomized controlled design.

PARTICIPANTS AND METHODS

Patients admitted to Daido Hospital within 48 h after the onset of symptoms related to stroke between December 2021 and December 2023 were included in this study. The inclusion criteria included 1) age between 20 and 85 years, 2) ability to walk independently or with assistance prior to onset, and 3) be able to initiate HAL training within one week of onset. The exclusion criteria comprised 1) communication difficulties due to impaired consciousness, cognitive impairment, or mental illness; 2) challenges in detecting BES due to severe paralysis; 3) previous stroke history; 4) post-aneurysmal subarachnoid hemorrhage; 5) walking difficulties due to brain or muscle disorders unrelated to acute stroke; 6) use of implanted active medical devices or electronic devices; and 7) exercise risks associated with myocardial infarction, angina, severe hypertension (≥200/120 mmHg), orthostatic hypotension, deep vein thrombosis, or chronic respiratory failure. The ethics committee of Daido Hospital approved the study (ECD2021-015), and informed consent was obtained from participants after verifying eligibility based on the inclusion and exclusion criteria.

In this study, we used the lumbar-type HAL model, HAL-BB04, to assess well-being. Participants were randomly assigned to either the group receiving training using the lumbar-type HAL (HAL group) or the group receiving conventional rehabilitation therapy only (CPT group). Allocation was performed by a third party that did not conduct any evaluation or statistical analysis of the study. Simple randomization was performed using uniform random numbers generated in Excel (Microsoft, Redmond, WA, USA).

The rehabilitation treatment was conducted for 14 days, including the evaluation period (Fig. 1). The Berg Balance Scale (BBS), Functional Independence Measure (FIM), Stroke Impairment Assessment Set-motor (SIAS-m), Brunnstrom stage (BRS), and Functional Ambulation Category (FAC) were evaluated before the intervention (pre-intervention assessments) and immediately after the end of the 2-week training period (post-intervention assessments). During the motor evaluation, physical therapists supported the patients in preventing falls as needed.

Fig. 1.

Fig. 1.

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Study flowchart.

This single-center randomized controlled trial consisted of three phases: pre-intervention assessment, intervention, and post-intervention assessment. Before the pre-intervention assessment, participants are randomly assigned to either the group receiving conventional physical therapy (CPT group) or the group using the lumbar-type Hybrid Assistive Limb (HAL) (HAL group). BBS: Berg Balance Scale; BRS: Brunnstrom recovery stage; CPT: conventional physical therapy; FAC: functional ambulation categories; FIM: functional independence measure; HAL: Hybrid Assistive Limb; SIAS-m: stroke impairment assessment set-motor.

The BBS evaluates balance ability by scoring 0 to 4 points on 14 balance tasks, and the total score is used to assess balance ability29). ADL was evaluated using the FIM, which consists of 13 motor items and five cognitive items, totaling 18 items, with a maximum score of 126 points30). The function of the paralyzed upper and lower limbs was evaluated using the total scores of the SIAS motor items31) and the BRS32). Walking ability was assessed using the FAC. The FAC is a clinical assessment scale based on the amount of assistance required for walking33). Patients were asked to report any adverse effects, including unusual sensations, before, during, and after the experiment.

Fitting was confirmed and adjusted using the lumbar-type HAL during the pre-intervention assessment. In the HAL group, HAL training started after the pre-intervention assessment, and each HAL training session lasted 40 min, including rest and device attachment/detachment time. The HAL group used the lumbar-type HAL for 10 days and continued conventional rehabilitation therapy during the HAL training period. After HAL training, only conventional rehabilitation therapy was administered. The total training time was adjusted to be the same for both HAL and CPT groups, including the HAL training sessions. The electrode was attached to the lumbar erector spinae or gluteus maximus muscles on the healthy side to ensure reliable detection of BES, as neural conduction on the affected side may be impaired in stroke patients. The muscles were selected based on which muscles allowed the HAL drive to assist the participant more smoothly (Fig. 2). The lumbar-type HAL has two modes, cybernetic voluntary control (CVC, controlling the torque generated from BES detected by the electrodes) and cybernetic autonomous control (CAC, controlling the torque based on ideal standing motion patterns). Each mode can be set from 0 to 5 in intensity to provide support based on the difficulty of the movement. Both CVC and CAC modes were adjusted flexibly by physical therapists, who had undergone safety training for the HAL device, to match the patient’s functional status, progress, and capabilities. No specific order was mandated for their use.

Fig. 2.

Fig. 2.

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Example of applying the bioelectrical signals (BES) sensor.

Electrodes detecting bioelectrical signals (BES) are attached to the skin over the lumbar erector spinae muscles in the non-affected right or left side of the patient, with the reference electrode placed on the side.

The HAL group included training content, such as approximately 10 repetitions of trunk flexion and extension exercises in a sitting position, followed by standing training (Fig. 3). The standing training focused on “leaning forward with the trunk”. The height of the platform used for standing exercises was fixed at 44 cm. For those with an unstable standing posture, training was conducted by having them hold onto a walker with their unaffected side. The number of repetitions for standing training was not specified, and the patients performed as many repetitions as possible within the training period according to their fatigue level. The assistance level was adjusted according to the patient’s physical condition.

Fig. 3.

Fig. 3.

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Hybrid assistive limb (HAL)-assisted exercise.

The standing training focused on “leaning forward with the trunk”. For those with an unstable standing posture, training was conducted by having them hold onto a walker with their unaffected side.

In the CPT group, only conventional rehabilitation treatments were provided, such as standing training similar to that in the HAL group but without HAL, range-of-motion exercises, muscle strengthening exercises, and gait training using orthoses.

Differences in the baseline variables between the HAL and CPT groups were tested using Fisher’s exact test for categorical data and independent t-tests for continuous data. Within-group comparisons of outcomes at baseline and 2 weeks after training were performed using the Wilcoxon signed-rank test. The degree of improvement for each participant was calculated as the difference between the post-intervention value (Ypost) and the baseline value (Ypre), expressed as ΔY=Ypost−Ypre. The Mann–Whitney U test was used to compare the distributions of ΔY between two groups. This non-parametric method evaluates differences in medians between two independent groups. All ΔY values were ranked across the combined dataset, and the U statistic was calculated based on the sum of ranks. Spearman’s rank correlation analysis was conducted to assess the relationship between two factors. Values are presented as mean ± standard deviation. Statistical analyses were performed using SPSS 29.0.2.0 (IBM, Armonk, NY, USA). Statistical significance was set at p<0.05.

RESULTS

In total, 15 patients (median age, 67 years; seven in the HAL group, eight in the CPT group) were included in this study (Tables 1 and 2). In the clinical evaluation, no significant differences in baseline characteristics were observed between the two groups (Table 1). During the study period, none of the patients in either group experienced orthostatic hypotension, abrasion, or falls, suggesting that training using the lumbar-type HAL is safe, even in the acute stage of stroke.

Table 1. Baseline demographics of two cohorts.

HAL group (n=7) CPT group (n=8)
Age (years)a 66.6 ± 9.3 65.1 ± 11.1
Female, nb 1 0
Diagnosis, n
Cerebral infarctionb 6 6
Cerebral hemorrhageb 1 2
Lesion side, n
Rightb 5 4
Leftb 2 4
Interval (days)a 3.1 ± 2.0 3.5 ± 1.8
Total training duration (days)a 12.6 ± 1.8 13.5 ± 0.9
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Measured values are presented as means ± SD. aIndependent t-test; bFisher’s exact test. *p<0.05, **p<0.01, ***p<0.001.

Interval refers to the days elapsed from stroke onset to the beginning of intervention. Patients excluded from the study is not listed.

HAL: Hybrid Assistive Limb; CPT: conventional physical therapy.

Table 2. The effect of rehabilitation compared within and between two groups.

Measures HAL group (n=7) CPT group (n=8) The changes from baseline (ΔY=Ypost−Ypre)
compared between the HAL and CPT groups
Pre Post Pre Post
BBS 18.7 ± 18.1 37.3 ± 12.1* 29.0 ± 22.1 36.3 ± 21.3* 11.3*
FIM-total 51.3 ± 17.5 75.1 ± 19.9* 57.1 ± 25.2 84.8 ± 28.5* −3.8
FIM-motor 29.1 ± 13.9 49.7 ± 14.6* 32.3 ± 17.8 57.1 ± 22.6* −4.2
FIM-cognitive 22.1 ± 8.5 25.4 ± 7.5 24.8 ± 8.6 27.6 ± 7.6* 0.4
SIAS-m 15.1 ± 6.2 18.6 ± 6.2* 12.5 ± 8.6 17.1 ± 8.2* −1.2
BRS-Upper limb 4.0 ± 1.7 4.7 ± 1.1 3.5 ± 1.7 3.9 ± 1.6 0.3
BRS-Finger 4.1 ± 1.6 5.1 ± 0.9 3.9 ± 1.7 4.1 ± 1.6 0.8
BRS-Lower limb 4.4 ± 1.4 4.7 ± 1.4 4.0 ± 1.8 4.5 ± 1.7 −0.2
FAC 0.86 ± 1.2 1.7 ± 1.6 1.0 ± 1.2 2.1 ± 1.9* −0.3
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Measured values are presented as means ± SD. *p<0.05, **p<0.01, ***p<0.001.

Differences within groups was analyzed by Wilcoxon signed-rank test, and differences between groups by Mann–Whitney U test.

HAL: Hybrid Assistive Limb; CPT: conventional physical therapy; BBS: Berg balance scale; FIM: functional independence measure; SIAS-m: stroke impairment assessment set-motor; BRS: Brunnstrom stage; FAC: functional ambulation categories.

The total number of rehabilitation days was 12.6 ± 1.8 days in the HAL group and 13.5 ± 0.9 days in the CPT group, with no significant difference (p=0.336). Within each group, the outcome measures were compared at baseline and 2 weeks after training (Table 2). In the HAL group, significant improvements after training were observed in the BBS (p=0.018), FIM-total (p=0.018), FIM-motor (p=0.018), and SIAS-m (p=0.041) scores. In the CPT group, significant improvements were observed in BBS (p=0.050), FIM-total (p=0.012), FIM-motor (p=0.012), FIM-cognitive (p=0.027), SIAS-m (p=0.017), and FAC (p=0.041) scores. When the changes from baseline for each item were compared between the HAL and CPT groups, a significant difference was observed only in the BBS score (p=0.021; Table 2). This finding indicates that the HAL group achieved a significant improvement in balance function, as measured by the BBS, compared to the CPT group. In contrast, no significant differences in changes from baseline were detected for other items, suggesting that the outcomes for those measures were comparable between the two groups. No significant differences were observed between the two groups in SIAS-m, FIM, or FAC.

Spearman’s rank correlation analysis did not reveal significant correlations between the BBS and the various functional outcome measures: BBS and FIM-total (r=0.165, p=0.556), BBS and FIM-motor (r=0.262, p=0.346), BBS and FIM-cognitive (r=−0.160, p=0.569), BBS and SIAS-m (r=0.351, p=0.200), BBS and BRS-Upper limb (r=0.173, p=0.538), BBS and BRS-Finger (r=0.167, p=0.552), BBS and BRS-Lower limb (r=0.391, p=0.150), and BBS and FAC (r=0.088, p=0.756).

DISCUSSION

To the best of our knowledge, this is the first study to use the lumbar-type HAL in patients with acute stroke. Both groups exhibited significant improvements in BBS, FIM-total, FIM-motor, and SIAS-m scores after training.

The HAL group showed a particularly pronounced improvement in BBS, while the CPT group exhibited significant within-group improvements in FIM-cognitive and FAC scores. However, no significant differences were observed between the two groups in FIM-cognitive and FAC scores in the between-group comparison. Therefore, enhancing communication during HAL training and optimizing protocols may help improve cognitive function and FAC scores. Furthermore, HAL demonstrated a clear advantage in improving trunk function as measured by BBS, with the added potential to reduce the physical burden on therapists. Based on these findings, rehabilitation strategies should be tailored to the nature of the functional disability, with HAL serving as a viable option for enhancing trunk function in the acute stage of stroke.

Even though there were no significant differences in the between-group comparison, the CPT group exhibited significant within-group improvements in FAC and FIM-cognitive scores. These findings suggest that the differences in training focus and time allocation may have influenced the results. HAL training involves one-on-one interaction between therapists and patients, but time allocated to setup, adjustment, and facilitation may reduce direct communication opportunities compared to CPT. In contrast, CPT may have allowed more time for gait training due to the absence of trunk-specific exercises, potentially contributing to the observed improvements in FAC scores and cognitive function. However, the lack of significant differences in FAC scores between the two groups may also be attributed to the relatively short intervention period in this study, which could have been insufficient to observe marked changes in walking ability. Additionally, the shared elements of basic gait training in both groups may have led to similar outcomes in FAC scores.

Stroke patients can promote neuroplasticity through appropriate rehabilitation, leading to the reorganization of damaged neural circuits and the formation of new neural pathways34). HAL interprets the wearer’s movement intentions and effectively supports movements aligned with these intentions, thus activating the neural pathways between the brain and muscles. With HAL, wearers can consistently execute the desired movements independent of the therapist’s experience, thereby facilitating the reorganization of neural circuits35). The lumbar-type HAL assists with hip extension and supports standing and balance movements, thereby strengthening the neural circuits required for these movements. The lumbar-type HAL is not a device that directly increases muscle strength but instead supports the repeated assistance of intended movements, aiding in the relearning of movement patterns, which results in improved balance ability without directly increasing muscle strength. In the present study, although BRS in both the upper and lower extremities remained unchanged after the HAL intervention, BBS scores showed significant improvement. Thus, the impact of HAL may involve relearning and modifying the neural circuits associated with truncal balance.

The significant improvement in BBS scores observed in the HAL group underscores the importance of balance training in stroke rehabilitation. Enhancements in balance ability are not only critical for trunk stability but are also closely associated with reducing fall risk and improving overall functional independence. Falls in stroke patients are a serious issue, leading to secondary disabilities such as readmission and fractures36) and it has been shown that balance disorders in the acute phase of stroke predict cognitive impairment 1 year after stroke37). Improvements in BBS scores have been shown to reduce fall risk38). No falls were reported in either group during the hospital stay. However, since long-term data were not collected in the present study, longitudinal data will be needed in order to understand the risk of fall and balance after stroke.

Additionally, the BBS is related to walking stability, and improvements in balance ability are expected to lead to improvements in walking function39). This can enhance patient mobility and maximize the effectiveness of rehabilitation. Furthermore, it has been suggested that balance training may also positively impact cognitive function40), and improvements in BBS may promote overall functional recovery. Therefore, improvements in BBS scores may contribute to reducing fall risk and enhancing ADL independence, resulting in an improved quality of life and promotion of psychological health. Rehabilitation using the lumbar-type HAL may significantly impact future ADL improvements in patients with acute stroke by contributing to improved BBS scores.

To compare this study with previous reports using the lower limb-type HAL in patients with acute stroke, we summarized previous studies. In a study by Chihara et al.18), rehabilitation using the lower limb-type HAL was performed in 15 acute stroke patients, and it was suggested that HAL training was effective for patients with high visuospatial perception and communication skills without causing pain. Yokota et al.19) compared early walking training between a HAL group and a CPT group comprising a total of 24 patients with acute stroke to investigate whether it was effective in improving walking ability and independence. No significant differences were observed between the HAL and CPT groups. However, a tendency toward a decrease in apathy scores was observed in the HAL group, suggesting that rehabilitation using HAL may contribute to the improvement of apathy. In a study by Degami et al.20), early initiation of gait training using the lower limb-type HAL was investigated in 63 stroke patients to determine whether it improved functional outcomes. Early initiation of gait training using HAL was effective in improving lower limb motor function and disability in stroke patients, emphasizing the importance of early intervention. Fukuda et al.21) evaluated the effectiveness of HAL in 53 patients with acute stroke classified according to the severity of paralysis. Significant improvements were observed in patients with mild to moderate paralysis, but the effects were limited to patients with severe paralysis. It has been suggested that for patients with severe paralysis, it might be beneficial to perform standing and balance training before gait training. In a study by Morishita and Inoue22), rehabilitation was conducted in 14 patients using a combination of single-joint types for the elbow and knee joints and lower limb types of HAL, and the results were reported. A tailor-made rehabilitation approach combining multiple HAL types may promote functional recovery in patients, and the lower limb-type HAL was found effective in improving walking ability and lower limb function in patients with acute stroke.

The results of this study align with previous studies using lower limb-type HAL but highlight the unique advantages of the lumbar-type HAL, particularly in enhancing trunk stability and balance function. The lumbar-type HAL is likely to improve motor function by assisting movements required for balance and enhancing trunk stability when worn on the waist. While lower limb-type HAL has proven effective in improving walking ability and promoting independence in ADLs for patients with acute stroke, its complexity and time-consuming setup may limit its practicality in acute clinical settings. In contrast, the lumbar-type HAL, with its simpler design and focus on trunk stabilization, offers a more accessible option for early-stage rehabilitation. These differences highlight the potential for tailored application of HAL devices depending on the specific needs and functional goals of patients.

The present study has several limitations. The sample size was small, and the study period was limited, and the high cost of HAL maintenance may further restrict its widespread clinical application. Additionally, long-term follow-ups to evaluate the sustainability of balance and walking improvements and their impact on ADLs over time were not included in this study. To address these limitations, future longitudinal comparative studies with larger sample sizes are warranted. Despite these limitations, this study highlights the potential of lumbar-type HAL as an innovative rehabilitation tool, emphasizing its unique role in enhancing trunk function and balance in the acute stage of stroke.

Funding

This work was supported by the KAKENHI Grant-in-Aid for Scientific Research (23K10509).

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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