Long-term survival following molecular-targeted therapy for intramedullary non-small-cell lung cancer metastasis.

Background: Intramedullary spinal cord metastases (ICSMs) are very rarely curable; these patients typically have very short-term survival rates. Here, a 22-year-old male with non-small-cell lung cancer (NSCLC) later developed ICSM twice; the first C4-C7 tumor responded well to surgery, radiation, and alectinib molecular-targeted therapy. The secondary ICSM C1 lesion seen years later (i.e., likely due to alectinib having been stopped) resolved once alectinib was again administered. Case Description: A 22-year-old male with a limited smoking history presented with advanced non-small-cell lung cancer (NSCLC) treated with pulmonary surgery followed by radiotherapy and chemotherapy. Four years later, he developed cervical myelopathy attributed to a C4-C7 stage IV NSCLC ICSM (i.e., notably associated with an anaplastic lymphoma kinase [ALK] rearrangement). After cervical surgery and irradiation (40 Gy/20 fr) of the resection cavity, he was also given alectinib; the patient remained disease-free for the next 7 years, remaining on alectinib. However, 1 year after alectinib was discontinued, he experienced a newly occurrent C1 ICSM lesion; the alectinib was restarted, and his tumor regressed over the next 3 years. At present, 14 years after the original ICSM surgery, the patient remains disease free but continued alectinib (Karnofsky Performance Scale: 90%). Conclusion: Although the prognosis for ICSM is generally poor, molecular-targeted therapies, such as alectinib, as administered in this case, may provide long-term survival for patients with ALK-positive NSCLC tumors.

Prevertebral Soft-tissue Swelling Following One-level Anterior Cervical Discectomy and Fusion: An Analysis Based on Surgical Level.

BACKGROUND: The purposes of this study were to identify the primary level at which PSTS occurs following one level anterior cervical discectomy and fusion (ACDF) based on surgical level, and to quantify the degree to which it occurs. Although prevertebral tissue swelling (PSTS) peaks at day 2 or 3 after ACDF, with swelling noted to be prominent at levels C2-4, the way in which the features of PSTS vary according to surgical level has not been examined. METHODS: 37 patients who underwent one-level ACDF were reviewed and classified into retropharyngeal and retrotracheal group based on surgical level. PSTS occurring at C2-C6 and the width of airway (WA) at C2-C4 was assessed using plain radiographs before surgery and at 1, 3, 5, and 7 days postoperatively. RESULTS: The retropharyngeal group comprised 10 patients while the retrotracheal group comprised 27 patients. Retropharyngeal group had the most severe PSTS on day 3 after surgery. C4 showed PSTS peaked on day 3, with a value of 3.26 times the preoperative prevertebral tissue thickness. WA at C4 was narrowest on day 1, with a value of 0.74 times and remained narrow until day 3. The retrotracheal group showed the most severe PSTS on day 1 at level C3:2.81 times. WA at C4 was narrowest on day 1 with a value of 0.78 times and increased thereafter. CONCLUSIONS: PSTS following one-level ACDF for both retropharyngeal and retrotracheal lesions was greatest at the C3 and C4 levels, with peaks on the third day after operation for the former, and the first day for the latter. WA at C4 was narrowest from day 1 in both groups. In the retrophyaryngeal group, narrowing remained until day 3.

Efficacy and Safety of Edoxaban in Anticoagulant Therapy Early After Surgical Bioprosthetic Valve Replacement: Rationale and Design of the ENBALV Trial.

BACKGROUND AND PURPOSE: Anticoagulant therapy with vitamin K antagonists is recommended within 3 to 6 months after bioprosthetic valve replacement to prevent thromboembolic events. However, data regarding whether direct oral anticoagulants can be an alternative to warfarin in such patients are limited. The purpose of this study is to compare the efficacy and safety of edoxaban versus warfarin within 3 months after bioprosthetic valve replacement. METHODS: The ENBALV trial is an investigator-initiated, phase 3, randomized, open-label, multicenter study. It involves patients aged 18 to 85 years undergoing bioprosthetic valve replacement at the aortic and/or mitral position. They are randomized 1:1 to receive either edoxaban or warfarin. Administration of edoxaban or warfarin is to be continued for 12 weeks after surgery. The primary outcome is the occurrence rate of stroke or systemic embolism at 12 weeks after surgery. The net clinical outcome is a composite of stroke, systemic embolism, or major bleeding, which is included in the secondary outcomes. CONCLUSION: The ENBALV trial demonstrates the efficacy and safety of edoxaban compared with warfarin in patients early after bioprosthetic valve replacement, including patients with sinus rhythm, which will bring a significant benefit to patients in clinical practice. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) 2051210209. 30 Mar 2022 https://jrct.niph.go.jp/latest-detail/jRCT2051210209 .

Prognostic Factors Associated with Poor Treatment Outcomes After Balloon Kyphoplasty in Elderly Patients Aged ≥81 years.

OBJECTIVE: Balloon kyphoplasty (BKP) is an effective procedure for osteoporotic vertebral compression fractures; however, there is limited data regarding its outcomes in patients aged ≥81 years. This study investigated the treatment outcomes and prognostic factors for BKP in this age group. METHODS: A retrospective analysis was conducted on 115 patients with osteoporotic vertebral compression fracture undergoing single-level BKP after failed conservative treatment, classified into the <81 years (n=70) and ≥81 years (n=45) groups. Surgical results were evaluated as good outcomes (independent indoors 1 year postoperatively) and poor outcomes, followed by univariate and multivariate analyses to determine prognostic factors correlating with these outcomes. RESULTS AND CONCLUSION: The majority of patients (<81 years: 85.7%; ≥81 years: 73.3%) had a good degree of independence at 1 year postoperatively, which was comparable in both groups. Further analysis of patients aged ≥81 years showed that longer duration from onset to surgery, more subsequent vertebral fractures, and lower preoperative body mass index were correlated with poorer outcomes postoperatively, and low body mass index, time from onset to surgery, and female sex were independent risk factors for these outcomes (area under the receiver operating characteristics curve: 0.91).

REsveratrol for VAscular cognitive impairment investigating cerebral Metabolism and Perfusion (REVAMP trial): a study protocol for a randomized, double-blind, placebo-controlled trial.

Background: Carotid artery stenosis or occlusion (CASO) is a major cause of vascular cognitive impairment (VCI). There is currently no effective treatment for VCI induced by CASO. Resveratrol, a type of polyphenol, improves cognitive performance in rat CASO models via pleiotropic effects. Furthermore, we previously reported the longevity gene, SIRT1, which can be activated by resveratrol, improves cognitive and cerebral blood flow impairment in mouse CASO models by activating endothelial nitric oxide synthase. However, clinical evidence remains limited. Methods: The REsveratrol for VAscular cognitive impairment investigating cerebral Metabolism and Perfusion (REVAMP) trial is a randomized, double-blind, placebo-controlled trial involving patients with asymptomatic CASO. Each participant will receive either 150 mg/day of resveratrol or a placebo for 35 weeks. The primary objective is to determine whether resveratrol improves cognitive impairment, as assessed using the Alzheimer's disease Assessment Scale-cognitive subscale 13. One of our secondary objectives is to determine whether resveratrol improves cerebral hemodynamic impairment as assessed via 15O-gas positron emission tomography. We will recruit 100 patients (50 per group). Discussion: The REVAMP trial may provide valuable insights into new therapeutic options, as multitarget neuroprotection could potentially improve cognitive function along with enhancements in cerebral hemodynamic status in patients with asymptomatic CASO.Clinical trial registration: The REVAMP trial was prospectively registered in the Japan Registry of Clinical Trials (jRCTs051230013) on April 13, 2023.

Acute cervical epidural abscess with concurrent calcium pyrophosphate deposition after cervical spinal surgery: A case report.

Background: Spinal epidural abscess (SEA) is a rare condition that may result in catastrophic outcomes. On the other hand, calcium pyrophosphate (CPP) deposition disease (CPPD) causes inflammatory arthritis. Spinal involvement of a crystal-induced inflammation caused by CPPD is also common. Surgery is a common risk factor for both SEA and CPPD; however, the postoperative acute onset of SEA complicated with CPPD is extremely rare. Case Description: A man in his 70s presented to our hospital, complaining of right upper limb weakness, loss of dexterity, and gait disturbance. The diagnosis of cervical spondylotic myelopathy was made, and he performed laminectomy at C3, C4, and C5 levels. Four days after the laminectomy, he suffered from acute neck pain, weakness, and hypoesthesia in his arms and legs. Magnetic resonance imaging revealed a mass occupying the dorsal epidural space of C6 and C7, compressing the cervical spinal cord. Considering the acute symptomatology, an acute spinal epidural hematoma after surgery was suspected; therefore, emergency C6 and C7 laminectomy was performed. Surgical findings indicated that the pressure inside the spinal canal was elevated, and the mass was purulent exudate. Pathological examination showed suppurative inflammation with concomitant deposition of CPP. SEA complicated with CPPD was considered; therefore, antibiotics and non-steroidal anti-inflammatory drugs were administered. The motor weakness and hypoesthesia were improved despite a slight residual deficit in his dexterity. Conclusion: An acute onset of SEA complicated with CPPD after cervical surgery has rarely been reported. The suppurative inflammation fostered by the crystal-induced inflammation may account for the acute symptomatology.

Relationship between Treatment Choices according to the Modified Osteoporotic Fracture Score and Posttreatment Radiographic Outcomes.

STUDY DESIGN: Retrospective observational study. PURPOSE: To evaluate the modified osteoporotic fracture (mOF) scores in three treatment groups and compare imaging findings in patients treated and not treated according to the mOF score-based treatment recommendation. OVERVIEW OF LITERATURE: The osteoporotic fracture (OF) score was established by the AO Spine to guide therapeutic decisions. To enhance its applicability, a mOF score was recently introduced. METHODS: Consecutive patients diagnosed with OFs at Fujieda Heisei Memorial Hospital were divided into three groups: nonsurgical therapy, balloon kyphoplasty (BKP), and open surgery groups. The mOF score was calculated, and the levels of independence and posttreatment imaging data were compared between patients treated and not treated according to the mOF score-based treatment recommendation. RESULTS: In total, 118 patients were included (nonsurgical therapy, n=57; BKP, n=48; open surgery, n=13), of whom 100 (85%) received treatment consistent with the mOF score-based treatment recommendation. In the BKP and open surgery groups, the mOF scorebased treatment recommendations were consistent with the actual treatment in 93% of the patients. However, in the nonsurgical group, the mOF score-based treatment recommendation was not consistent with the actual treatment in 25% of the patients. In this group, patients not treated according to the mOF score had significantly shorter vertebral body height, greater local kyphosis, and smaller sacral slope after treatment than patients treated according to the mOF score-based treatment recommendation. CONCLUSIONS: In the BKP and open surgery groups, the mOF scores were consistent with actual clinical selection. In the nonsurgical therapy group, patients not treated according to the mOF score-based treatment recommendation exhibited severe vertebral body deformity and a less well-balanced spine shape after treatment. The mOF score may help in selecting suitable treatments for OFs.

Subclinical myocardial damage after anthracycline chemotherapy in Japanese patients with breast cancer.

BACKGROUND: Data on the incidence, timing, and severity of myocardial damage after anthracycline-based chemotherapy (AC) in Japanese patients with breast cancer are limited. METHOD: We evaluated cancer therapy-related cardiac dysfunction (CTRCD) in Japanese women with breast cancer (n = 51) after the first AC according to the definitions of the 2022 European Society of Cardiology onco-cardiology guideline, including assessment of high-sensitivity troponin I (TnI) and B-type natriuretic peptide (BNP) levels. RESULTS: CTRCD was detected in 67 % of the patients (3.9 %, 7.8 %, 9.8 %, 43 %, 37 %, 22 %, 20 %, and 9.8 % of patients at 1 week and 1, 2, 3, 6, 9, 12, and 15 months post-AC, respectively) without significant left ventricular ejection fraction reduction (<50 %) and heart failure. Elevated TnI levels (>26 pg/mL) were found in 43 % of patients, and elevated BNP levels (≥35 pg/mL) were observed in 22 % of patients during the follow-up period. CONCLUSIONS: Approximately two-thirds of the Japanese patients in this study experienced CTRCD, which was frequently observed at 3 or 6 months post-AC. However, all patients with CTRCD were diagnosed with mild asymptomatic CTRCD. Although, these patients were diagnosed with mild asymptomatic CTRCD, careful long-term follow-up will be required.

The Effectiveness of Tritanium Cages in Preventing Osteolytic Vertebral Endplate Cysts After Lumbar Interbody Fusion.

OBJECTIVE: Lumbar interbody fusion (LIF) is a common surgical procedure, but postoperative complications, such as osteolytic vertebral endplate cysts, can adversely affect patient outcomes. This study aims to investigate whether tritanium cages (Stryker, Mahwah, New Jersey, USA) are effective in preventing osteolytic vertebral endplate cysts after LIF. METHODS: Clinical data from 8 years (2013-2020) of LIF procedures at our hospital were analyzed. Computed tomography was used to assess the formation of osteolytic vertebral endplate cysts 6 months after surgery. Clinical factors potentially associated with cyst formation were compared among 3 different interbody spacer materials: tritanium, titanium, and polyetheretherketone. RESULTS: LIF was performed for 169 patients at 205 spinal levels, employing tritanium cages in 56 levels (48 patients), titanium in 103 levels (86 patients), and polyetheretherketone in 46 levels (35 patients). At 6 months after LIF, 27.3% of patients showed worsening of osteolytic vertebral endplate cysts. Multivariate logistic regression analysis showed that tritanium cages (odds ratio [OR], 3.86; 95% confidence interval [CI], 1.46-10.21) and titanium (OR, 2.55; 95% CI, 1.13-5.75), and posterior LIF (OR, 5.74; 95% CI, 2.24-14.74) were associated with a reduced risk of postoperative osteolytic vertebral endplate cysts. CONCLUSIONS: Tritanium cages have shown promise in preventing postoperative osteolytic vertebral endplate cysts, suggesting their potential as a stable and effective choice in LIF procedures. These findings have significant implications for improving patient outcomes and warrant further investigation to optimize surgical techniques and materials.

Imaging of Perirenal and Intrarenal Lymphatic Vessels: Anatomy-based Approach.

The lymphatic system (or lymphatics) consists of lymphoid organs and lymphatic vessels. Despite the numerous previously published studies describing conditions related to perirenal and intrarenal lymphoid organs in the radiology literature, the radiologic findings of conditions related to intrarenal and perirenal lymphatic vessels have been scarcely reported. In the renal cortex, interlobular lymphatic capillaries do not have valves; therefore, lymph can travel along the primary route toward the hilum, as well as toward the capsular lymphatic plexus. These two lymphatic pathways can be opacified by contrast medium via pyelolymphatic backflow at CT urography, which reflects urinary contrast agent leakage into perirenal lymphatic vessels via forniceal rupture. Pyelolymphatic backflow toward the renal hilum should be distinguished from urinary leakage due to urinary injury. Delayed subcapsular contrast material retention via pyelolymphatic backflow, appearing as hyperattenuating subcapsular foci on CT images, mimics other subcapsular cystic diseases. In contrast to renal parapelvic cysts originating from the renal parenchyma, renal peripelvic cysts are known to be of lymphatic origin. Congenital renal lymphangiectasia is mainly seen in children and assessed and followed up at imaging. Several lymphatic conditions, including lymphatic leakage as an early complication and acquired renal lymphangiectasia as a late complication, are sometimes identified at imaging follow-up of kidney transplant. Lymphangiographic contrast material accumulation in the renal hilar lymphatic vessels is characteristic of chylo-urinary fistula. Chyluria appears as a fat-layering fluid-fluid level in the urinary bladder or upper urinary tract. Recognition of the anatomic pathway of tumor spread via lymphatic vessels at imaging is of clinical importance for accurate management at oncologic imaging. ©RSNA, 2024 Test Your Knowledge questions for this article are available in the supplemental material.

A multicenter, single-arm, phase II clinical trial of adrenomedullin in patients with cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy.

Background: Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL), the most common form of hereditary cerebral small vessel disease (SVD), currently lacks disease-modifying treatments. Adrenomedullin (AM), a vasoactive peptide with angiogenic, vasodilatory, anti-inflammatory, and anti-oxidative properties, shows potential effects on the neuro-glial-vascular unit. Objective: The AdrenoMedullin for CADASIL (AMCAD) study aims to assess the efficacy and safety of AM in patients with CADASIL. Sample size: Overall, 60 patients will be recruited. Methods: The AMCAD is a multicenter, investigator-initiated, single-arm phase II trial. Patients with a confirmed CADASIL diagnosis, based on NOTCH3 genetic testing, will receive an 8-h AM treatment (15 ng/kg/min) for 14 days following a baseline assessment (from day 1 to day 14). Follow-up evaluations will be performed on days 15, 28, 90, and 180. Study outcomes: The primary endpoint is the cerebral blood flow change rate in the frontal cortex, evaluated using arterial spin labeling magnetic resonance imaging, from baseline to day 28. Summary statistics, 95% confidence intervals, and a one-sample t-test will be used for analysis. Conclusion: The AMCAD study aims to represent the therapeutic potential of AM in patients with CADASIL, addressing an unmet medical need in this challenging condition. Clinical Trial Registration: jRCT 2,051,210,117 (https://jrct.niph.go.jp/en-latest-detail/jRCT2051210117).

Analysis of Neurogenic Bowel and Bladder Dysfunction Following Decompression Surgery for Cervical Spondylotic Myelopathy: A Prospective Cohort Study.

STUDY DESIGN: A prospective observational study. OBJECTIVES: To investigate preoperative prevalence of neurogenic bowel dysfunction and neurogenic bladder in patients with degenerative cervical myelopathy (DCM) and examine the degree and timing of symptom improvement after cervical decompression surgery. Factors contributing to symptom improvement were also analyzed. METHODS: Among 75 patients with DCM who underwent cervical decompression, Constipation Scoring System (CSS) score, International Prostate Symptoms Score (IPSS), and Japanese Orthopaedic Association (JOA) score were assessed before surgery and 1, 3, 6, and 12 months after. Prevalence rates were calculated. Data regarding patient age, sex, disease status, disease duration, lesion level, and score changes was prospectively recorded and analyzed. RESULTS: The prevalence rates of defecation and urinary dysfunction before surgery were 41.3% and 34.7%, respectively. Among the patients with defecation dysfunction, the number of patients who improved 1, 3, 6, and 12 months after surgery was 10, 9, 9, and 6, respectively. Among the patients with urinary dysfunction, the corresponding number of patients was 12, 10, 11, and 11, respectively. None of the factors we examined were significantly associated with improvement in either CSS or IPSS score; however, improvement of lower extremity JOA score tended to be associated with improvement in both. CONCLUSIONS: The prevalence of symptoms of defecation and urinary dysfunction in patients with DCM was 41.3% and 34.7%, respectively. Decompression surgery improved symptoms in 20% to 46% of patients.

Unrecognized dural tear during percutaneous endoscopic lumbar surgery confirmed with myelography.

Iatrogenic dural tear is usually recognized during the surgery. We describe a rare case of unrecognized dural tear caused by percutaneous endoscopic lumbar surgery at another hospital clearly confirmed with dynamic myelography. Although magnetic resonance imaging of the lumbar spine showed no obvious fluid collection suggesting dural tear, dynamic myelography revealed leakage of intradural subarachnoid contrast medium along root sleeve into the intervertebral disc space. In the setting of endoscopic spine surgery, incidental dural tear might be overlooked due to the narrow and fluid-filled surgical field. Dynamic myelography is useful to evaluate the precise condition caused by unrecognized dural tear.

Postoperative intractable leg pain caused by dislocation of drainage tube.

Background: A wide variety of conditions can cause recurrent postoperative lumbar radiculopathy. Case Description: A 49-year-old female developed sudden recurrent postoperative right leg pain after a right-sided L5S1 microdiskectomy for a herniated disc. Emergent magnetic resonance and computed tomography studies demonstrated migration of the drainage tube into the right L5S1 lateral recess compromising the S1 nerve root. Following drain removal, the patient's right reg pain immediately resolved. Conclusion: Migration of a lumbar wound drain into the operated lateral recess following a lumbar diskectomy may result in acute, recurrent/intractable radicular pain that was readily resolved with drain removal.

Intraoperative complications of vertebral body stenting system.

Background: Vertebral body stenting systems (VBSs) are superior to balloon kyphoplasty for performing vertebral augmentation and height restoration. However, VBS may likely result in more material-related complications that have been under-reported. Here, an 84-year-old female's vertebral stents "toppled over" before the filling cement was fully applied, thus necessitating an additional posterior fusion. Case Description: An 84-year-old female presented with low back pain after a fall. Dynamic standing and decubitus X-rays revealed a vertebral compression fracture at T12 resulting in an intravertebral vacuum cleft (i.e., the lowermost level of diffuse idiopathic skeletal hyperostosis). When the VBS was performed, the stents "toppled over" just after removing the balloon catheters; we successfully restored with the cement volume in one stent but not the other, thus warranting an additional posterior fusion to maintain stability. Conclusion: The proper injection of cement into a VBS requires dual correct stent positioning, and careful control of requisite stent expansion. In an 84-year-old female with a T12 vertebral body fracture and a remarkable vacuum cleft, the VBS procedure resulted in an inadvertent injection into one stent thus warranting a secondary posterior fusion.

Unilateral Lumbosacral Facet Abnormality Resembling Facet Interlocking: A Case Report.

We report a rare case presenting radiculopathy caused by unilateral lumbosacral facet abnormality resembling facet interlocking. The patient was a 57-year-old man with no medical and traumatic history. He began to exhibit numbness below his left ankle followed by pain at the left buttock with no obvious causes. He visited our hospital approximately 1 year after the onset of his symptom. Preoperative images revealed a left lumbosacral facet abnormality resembling facet interlocking. His left S1 nerve root was compressed by the dislocated left L5 inferior articular process and bone fragment. His symptom was consistent with left S1 radiculopathy without an obvious stenosis of the left L5 intervertebral foramen; thus, we performed partial facetectomy of the left L5/S1, posterior decompression of the S1 nerve root tunnel, and removal of bone fragment. After the operation, his symptom completely disappeared with satisfactory result. There are several types of congenital facet anomalies in the lumbosacral facet joint; however, congenital unilateral lumbosacral facet abnormality resembling facet interlocking described in this paper has not been reported. His clinical symptom was completely recovered after simple decompression surgery. In this paper, we report the interesting and unique findings of facet abnormality resembling facet interlocking.

Correction: Takeuchi et al. Predictive Factors for Poor Outcome following Chemonucleolysis with Condoliase in Lumbar Disc Herniation. Medicina 2022, 58, 1868.

In the original publication [...].

LC-MS/MS analysis of elastin crosslinker desmosines and microscopic evaluation in clinical samples of patients with hypertrophy of ligamentum flavum.

Ligamentum flavum (LF) pathologies often lead to severe myelopathy or radiculopathy characterized by reduced elasticity, obvious thickening, or worsened ossification. Elastin endows critical mechanical properties to tissues and organs such as vertebrae and ligaments. Desmosine (DES) and isodesmosine (IDES) are crosslinkers of elastin monomers called tropoelastin. These crosslinkers are potential biomarkers of chronic obstructive pulmonary disease. As a biological diagnostic tool that supplements existing symptomatic, magnetic resonance imaging scanning or radiological imaging diagnostic measures for LF hypertrophy and associated pathologies, an isotope-dilution liquid chromatography-tandem mass spectrometry method with selected reaction monitoring mode for the quantitation of DESs in human plasma, urine, cerebrospinal fluid (CSF), and yellow ligamentum was investigated. Isotopically labeled IDES-13C3,15N1 was used as an internal standard (ISTD) for DES quantitation for the first time. The samples plus ISTD were hydrolyzed with 6 N hydrochloric acid. Analytes and ISTD were extracted using a solid phase extraction cellulose cartridge column. The assays were repeatable, reproducible, and accurate with % CV ≤ 7.7, ISTD area % RSD of 7.6, and % AC ≤ (101.2 ± 3.90) of the calibrations. The ligamentum samples gave the highest average DES/IDES content (2.38 µg/mg) on a dry-weight basis. A high percentage of the CSF samples showed almost no DESs. Urine and plasma samples of patients showed no significant difference from the control (p-value = 0.0519 and 0.5707, respectively). Microscopy of the yellow ligamentum samples revealed dark or blue-colored zones of elastin fibers that retained the hematoxylin dye and highly red-colored zones of collagen after counterstaining with van Gieson solution. Thus, we successfully developed a method for DES/IDES quantitation in clinical samples.

Effect of cyborg-type robot Hybrid Assistive Limb on patients with severe walking disability in acute stroke: A randomized controlled study.

OBJECTIVES: To investigate whether early gait training using Hybrid Assistive Limb (HAL) is feasible and improves walking and independency compared with conventional physical therapy (CPT) in patients with severe walking disability after stroke. METHODS: We conducted a single-center, randomized controlled study. Patients with first-ever stroke who had severe walking disability were included. All patients started gait training within 10 days post-stroke onset. Twenty-four patients were randomly assigned into HAL or CPT groups. Outcome measures were collected at three time points, at baseline, completion of 20 sessions of gait training (second assessment), and 3 months after the initiation of gait training. The primary outcomes were changes in motor sub-scores of the Functional Independence Measure or Functional Ambulation Category at the completion of the second assessment from baseline. RESULTS: Twenty-two patients (median age, 68 years; 12 patients in the HAL group and 10 patients in the CPT group) completed the study. There were no significant differences in primary outcomes. Apathy scale, one of the secondary outcomes, showed a decreasing trend in the HAL group (mean change of -3.8, 95% CI -8.14 to 0.475), and a slight increasing trend in the CPT group (mean change of 1.2, 95% CI -2.66 to 5.06) at the second assessment. Patients in the HAL group experienced no adverse events. CONCLUSIONS: Early gait training in patients with severe walking disability after stroke using HAL was feasible. Walking ability and independency were not improved at the completion of 20 sessions of gait training.