Feasibility and safety study of wearable cyborg Hybrid Assistive Limb for pediatric patients with cerebral palsy and spinal cord disorders.

Introduction: The wearable cyborg Hybrid Assistive Limb (HAL) is the world's first cyborg-type wearable robotic device, and it assists the user's voluntary movements and facilitates muscle activities. However, since the minimum height required for using the HAL is 150 cm, a smaller HAL (2S size) has been newly developed for pediatric use. This study aimed to (1) examine the feasibility and safety of a protocol for treatments with HAL (2S size) in pediatric patients and (2) explore the optimal method for assessing the efficacy of HAL. Methods: This clinical study included seven pediatric patients with postural and motor function disorders, who received 8-12 sessions of smaller HAL (2S size) treatment. The primary outcome was the Gross Motor Function Measure-88 (GMFM-88). The secondary outcomes were GMFM-66, 10-m walk test, 2- and 6-min walking distances, Canadian Occupational Performance Measure (COPM), a post-treatment questionnaire, adverse events, and device failures. Statistical analyses were performed using the paired samples t-test or Wilcoxon signed-rank test. Results: All participants completed the study protocol with no serious adverse events. GMFM-88 improved from 65.51 ± 21.97 to 66.72 ± 22.28 (p = 0.07). The improvements in the secondary outcomes were as follows: GMFM-66, 53.63 ± 11.94 to 54.96 ± 12.31, p = 0.04; step length, 0.32 ± 0.16 to 0.34 ± 0.16, p = 0.25; 2-MWD, 59.1 ± 57.0 to 62.8 ± 63.3, p = 0.54; COPM performance score, 3.7 ± 2.0 to 5.3 ± 1.9, p = 0.06; COPM satisfaction score, 3.3 ± 2.1 to 5.1 ± 2.1, p = 0.04. Discussion: In this exploratory study, we applied a new size of wearable cyborg HAL (2S size), to children with central nervous system disorders. We evaluated its safety, feasibility, and identified an optimal assessment method for multiple treatments. All participants completed the protocol with no serious adverse events. This study suggested that the GMFM would be an optimal assessment tool for validation trials of HAL (2S size) treatment in pediatric patients with posture and motor function disorders.

Structural validity of the Trunk Assessment Scale for Spinal Cord Injury (TASS) with Rasch analysis for individuals with spinal cord disorders.

OBJECTIVE: To confirm the structural validity of the Trunk Assessment Scale for Spinal Cord Injury (TASS). PARTICIPANTS AND METHODS: We evaluated 104 Japanese individuals with a spinal cord injury (SCI) (age 63.5 ± 12.2 years; 64 with tetraplegia) with the TASS 1-3 times. We conducted a Rasch analysis to assess the TASS' unidimensionality, fit statistics, category probability curve, ceiling/floor effects, local independence, reliability, and difference item function (DIF). RESULTS: The TASS was observed to be a unidimensional and highly reproducible scale of item difficulty hierarchy that sufficiently identifies the superiority of the examinee's ability. The TASS was easy for the participants of this study. One TASS item was a misfit based on the infit and outfit mean square; another item also showed a DIF contrast for age. Several items were found to require a synthesis or modification of the content. The TASS showed a floor effect, and most of the non-scorers were individuals with a complete SCI. CONCLUSION: Our findings clarify the structural validity of the TASS, and our analyses revealed that the TASS includes an unfitness item and was less challenging for individuals with SCIs. The improvements suggested by these results provide important information for modifying the TASS to a more useful instrument.

Validity of the trunk assessment scale for spinal cord injury (TASS) and the trunk control test in individuals with spinal cord injury.

BACKGROUND: The Trunk Assessment Scale for Spinal Cord Injury (TASS) and the Trunk Control Test for individuals with a Spinal Cord Injury (TCT-SCI) are highly reliable assessment tools for evaluating the trunk function of individuals with SCIs. However, the potential differences in the validity of these two scales are unclear. OBJECTIVES: To evaluate the criterion validity of the TASS and the construct validity of the TASS and TCT-SCI. PARTICIPANTS AND METHODS: We evaluated 30 individuals with SCIs (age 63.8 ± 10.7 yrs, 17 with tetraplegia). To evaluate criterion validity, we calculated Spearman's rho between the TASS and the gold standard (the TCT-SCI). To determine construct validity, we used the following hypothesis testing approaches: (i) calculating Spearman's rho between each scale and the upper and lower extremity motor scores (UEMS, LEMS), the Walking Index for SCI-II (WISCI-II), and the motor score of the Functional Independence Measure (mFIM); and (ii) determining the cut-off point for identifying ambulators with SCIs (≥ 3 points on item 12 of Spinal Cord Independent Measure III) by a receiver operating characteristics analysis. RESULTS: A moderate correlation was confirmed between the TASS and the TCT-SCI (r = 0.68). Construct validity was supported by six of the eight prior hypotheses. The cut-off points for identifying ambulators with SCIs were 26 points (TASS) and 18 points (TCT-SCI). CONCLUSION: Our results indicate that the contents of the TASS and the TCT-SCI might reflect the epidemiological characteristics of the populations in which they were developed.

A comparison between the shoulder shifting test and seated reaching test by bland-altman plot: A pilot study.

BACKGROUND: The Seated Reach Test (SRT) is an assessment tool for evaluating the sitting balance of individuals with a spinal cord injury (SCI). We developed the Shoulder Shifting Test (SST), which is a tool for measuring the reaching distance of individuals with difficulty in raising their arms, such as individuals with tetraplegia. OBJECTIVE: To investigate the agreement between the SST and the SRT and the usefulness of the SST. SUBJECTS AND METHODS: Sixteen subjects with SCI (age 52.9 ± 13.0 yrs; four with tetraplegia) performed the SST and the SRT. We determined the correlation coefficient to determine the relationship between the two tests. A Bland-Altman analysis was performed to confirm the systematic error, and the relative error (RE) was used to determine the compatibility of the two tests in three directions (front, right, left). We assessed the SST's usefulness by determining how many of 47 subjects (age 59.6 ± 13.6 yrs; 23 with tetraplegia) could not perform the SRT and how many could perform the SST. RESULTS: The tests were strongly correlated. No systematic errors between the tests were observed. In all three directions, >75% of the subjects had an RE <20%. Eleven of the 47 subjects with SCI were unable to perform either test. Four to ten of the 36 subjects performed the SST due to the difficulty in raising their arms. CONCLUSION: The SST was compatible with the SRT, and the sitting balance of more individuals with SCI could be assessed by the combination of these tests.

Responsiveness and minimal clinically important differences of the Trunk Assessment Scale for Spinal Cord injury (TASS).

OBJECTIVE: To confirm the responsiveness and minimal clinically important differences (MCIDs) of the Trunk Assessment Scale for Spinal Cord Injury (TASS). PARTICIPANTS AND METHODS: We evaluated 48 Japanese individuals with spinal cord injury (SCI) (age 64.1 ± 10.4 yrs, 28 with tetraplegia) admitted to two institutions at admission, at 1 month of hospitalization, and at discharge with the TASS, the Trunk Control Test in individuals with an SCI (TCT-SCI) motor score, the Functional Independence Measure motor score (mFIM), and the Global Rating of Change Scale (GRCS). We assessed the TASS responsiveness by determining the correlation coefficients for the changes in the TASS' and other assessments' scores. We calculated the MCIDs by five anchor-based methods. RESULTS: The changes in the TASS and those in the other assessments were weakly correlated at 1 month and moderately correlated at discharge. The TASS MCIDs were observed at 1 month and at discharge. CONCLUSION: Our findings confirmed that the change in TASS scores had weak-to-moderate correlations with the changes in the participants' upper- and lower-limb function and activities of daily living. Using the MCID for the TASS determined by anchor-based methods may lead to a better interpretation of changes in the trunk function of individuals with SCIs.

Reliability and minimal detectable change of the Trunk Assessment Scale for Spinal Cord Injury (TASS) and the trunk control test for individuals with spinal cord injury.

STUDY DESIGN: Cross-sectional study. OBJECTIVES: To evaluate the reliability and calculate the measurement error of the Trunk Assessment Scale for Spinal Cord Injury (TASS) and trunk control test (TCT-SCI) in individuals with spinal cord injury (SCI). SETTING: Rehabilitation Hospital in Japan. METHODS: The evaluations of TASS and TCT-SCI for individuals with SCI were video-recorded. The inter-rater reliability (two physiotherapists) was confirmed using the videos. ICC (2,1), kappa coefficient (κ) were used to determine the reliability of the total score and each item. Each minimal detectable change (MDC) was calculated. RESULTS: The TASS and TCT-SCI total scores showed excellent inter-rater reliability (ICC = 0.99, and 1.00). The kappa coefficients of TASS were acceptable to excellent for 8 items (κ = 0.76-1.00), below acceptable for 1 item (κ = 0.62). The kappa coefficients of TCT-SCI were excellent for 12 items (κ = 0.83-1.00), below acceptable for 1 item (κ = 0.68). The inter-rater MDC of the TASS total score was 4.07 points, and the MDC of the TCT-SCI total score was 1.13 points. The intra-rater MDC of the TASS total score was 3.86 points. CONCLUSION: Both TASS and TCT-SCI showed high reliability. Differences of less than four points in TASS and one point in TCT-SCI were interpreted as measurement errors between the two raters.

The Area of Impingement in the Throwing Versus Nonthrowing Shoulder of Collegiate Baseball Players: An MRI Study of the Simulated Late-Cocking Phase of Throwing.

BACKGROUND: During shoulder abduction and external rotation, internal impingement can occur when compressive forces between the greater tuberosity and the posterior glenoid rim pinch the undersurface of the rotator cuff. Previous studies on internal impingement have focused on qualitative results such as pathological findings; however, few studies have quantified the area of impingement (AOI) of the rotator cuff muscles between the greater tuberosity and the posterior glenoid rim. PURPOSE: To compare the AOI between the throwing and nonthrowing shoulders of baseball players. STUDY DESIGN: Controlled laboratory study. METHODS: A total of 14 asymptomatic male collegiate baseball players participated in this study. The AOI in both the throwing and the nonthrowing shoulders was calculated using magnetic resonance imaging (MRI) scans. The MRI measurements were collected with the shoulder at 90° of abduction and at 90° and 100° of external rotation. The area, width, and depth of impingement as well as cystic changes in the greater tuberosity and degeneration in the posterior labrum were compared between the throwing and nonthrowing shoulders. RESULTS: The AOI was significantly greater in the throwing shoulders than in the nonthrowing shoulders (90° of external rotation: 32.4 vs 19.1 mm2, respectively; 100° of external rotation, 28.0 vs 15.6 mm2, respectively; P < .001 for both). Compared with the nonthrowing shoulders, there were more positive findings in the throwing shoulders regarding greater tuberosity cystic changes (0 vs 7, respectively; P = .006) and posterior labral degeneration (3 vs 13, respectively; P < .001). CONCLUSION: The AOI and the number of lesions in the greater tuberosity and posterior labrum were greater in throwing shoulders than in nonthrowing shoulders. Therefore, damage to the insertion of the rotator cuff muscles may affect internal impingement. CLINICAL RELEVANCE: Lesions in the greater tuberosity and posterior labrum in throwing shoulders may increase the AOI by expanding the joint gap behind the glenohumeral joint. Impingement of the greater tuberosity and the posterior glenoid rim may lead to rotator cuff tears.

Investigation of inspiratory intercostal muscle activity in patients with spinal cord injury: a pilot study using electromyography, ultrasonography, and respiratory inductance plethysmography.

[Purpose] The respiratory function in patients with cervical spinal cord injury is influenced by inspiratory intercostal muscle function. However, inspiratory intercostal muscle activity has not been conclusively evaluated. We evaluated the inspiratory intercostal muscle activity in patients with cervical spinal cord injury by using inspiratory intercostal electromyography, respiratory inductance plethysmography, and ultrasonography. [Participants and Methods] Three patients with cervical spinal cord injury were assessed. The change in mean amplitude (rest vs. maximum inspiration) was calculated by using intercostal muscle electromyography. Changes in intercostal muscle thickness (resting expiration and maximum inspiration) were also evaluated on ultrasonography. The waveform was converted to spirometry ventilation with respiratory inductance plethysmography, and the waveform at the xiphoid was considered to determine the rib cage volume. Each index was compared with the inspiratory capacities in each case. [Results] Intercostal muscle electromyography failed to measure the notable myoelectric potential in all the patients. The rib cage volume was higher at higher inspiratory capacities. The changes in muscle thickness were not significantly different between the patients. [Conclusion] The rib cage volume (measured with inductance plethysmography) was greater in the patients with cervical spinal cord injury when inspiratory intercostal muscle activity was high. Respiratory inductance plethysmography can capture inspiratory intercostal muscle function in patients with cervical spinal cord injury.

Difference in sex and the effect of a dominant lower extremity in the posterior tibial slope angle in healthy Japanese subjects.

BACKGROUND/OBJECTIVE: Anterior cruciate ligament injuries are prone to re-injury, and it is crucial to prevent the primary injury. One of the anatomical risk factors for anterior cruciate ligament injury is the posterior tibial slope angle. Investigating the characteristics of healthy individuals with respect to the posterior tibial slope angle is important to elucidate the risk of developing anterior cruciate ligament injuries. The purpose of this study was to determine the characteristics related to sex and of the posterior tibial slope angle in healthy Japanese subjects, and the effect of the dominant lower extremity. METHODS: Sixty-two knees of 31 healthy Japanese college students (15 males and 16 females) were included in this study. Magnetic resonance images of both knee joints of the subjects were measured using a 0.3 T scanner. The medial and lateral posterior tibial slope angles were measured from the obtained magnetic resonance images. Magnetic resonance images of the knee joint of the dominant lower extremity were used to compare differences in sexes between the medial and lateral posterior tibial slope angles. Bilateral knee joint magnetic resonance images were used to compare the dominant and non-dominant lower extremities. Independent t-tests were used to compare the differences regarding sex in the medial and lateral posterior tibial slope angles and to compare the dominant and non-dominant lower extremities. RESULTS: A comparison of the mean lateral posterior tibial slope angle showed that males had a 8.8 ± 1.7° angle, while females had a 10.3 ± 2.2° angle, which was significantly greater (p = 0.047). There was no significant difference comparing the posterior tibial slope angle between the dominant and non-dominant lower extremities (p = 0.430). CONCLUSIONS: From the result of this study, the lateral posterior tibial slope angle was significantly higher in the female group than in the male group. However, both the medial and lateral posterior tibial slope angles were found to be unaffected by the dominant lower extremity.

Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial.

BACKGROUND: Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration. OBJECTIVE: This study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation. METHODS: This is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes preintervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and postintervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for preintervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly assessments using the 10-meter maximum walking speed [MWS] test). Patients with an MWS of 30-60 m/minute and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary outcome is the change in MWS from baseline to the end of the 5-week intervention. RESULTS: This study began in November 2016 and is being conducted at 15 participating facilities in Japan. CONCLUSIONS: Assessments of walking ability vary greatly and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce added recovery of walking ability, which would promote the use of HAL technology in the clinical setting. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000024805; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545.

Long-term sustained effect of gait training using a hybrid assistive limb on gait stability via prevention of knee collapse in a patient with cerebral palsy: a case report.

[Purpose] The hybrid assistive limb was developed to improve the kinematics and muscle activity in patients with neurological and orthopedic conditions. The purpose of the present study was to examine the long-term sustained effect of gait training using a hybrid assistive limb on gait stability, kinematics, and muscle activity by preventing knee collapse in a patient with cerebral palsy. [Participant and Methods] A 17 year-old male with cerebral palsy performed gait training with a hybrid assistive limb 12 times in 4 weeks. After completion of 12 sessions of hybrid assistive limb training, monthly follow-up was conducted for 8 months. The improvement was assessed on the basis of joint angle and muscle activity during gait. [Results] The degree of knee collapse observed at baseline was improved at 8-month follow-up. Regarding muscle activity, electromyography revealed increased activation of the vastus lateralis at 8-month follow-up. Moreover, the hip and knee angles were expanded during gait. In particular, the knee extension angle at heel contact was increased at 8 months after follow-up. [Conclusion] Gait training with a hybrid assistive limb provided improvement of gait stability such as kinematics and muscle activity in a patient with cerebral palsy. The improved gait stability through prevention of knee collapse achieved with hybrid assistive limb training sustained for 8 months.

Safety and immediate effect of gait training using a Hybrid Assistive Limb in patients with cerebral palsy.

[Purpose] This study aimed to determine the safety and immediate effect of a single training session with the Hybrid Assistive Limb (CYBERDYNE) on walking ability in patients with cerebral palsy. [Participants and Methods] This study included 20 patients with cerebral palsy (15 males, 5 females, mean age 15.0 ± 6.3 years; 19 with spastic cerebral palsy, 1 with athetoid cerebral palsy; Gross Motor Function Classification System level I: 4, II: 3, III: 9, and IV: 4). Participants completed a single 20-minute gait training session using the Hybrid Assistive Limb. The safety and immediate effect were evaluated. The immediate outcomes were gait speed and mean step length, and cadence before and after training. [Results] Two participants were excluded because they were not tall enough to use the Hybrid Assistive Limb. Eighteen participants performed the training. There were no serious adverse events during the training. Since 14 participants were able to walk on their own, walking evaluations were performed before and after training. Statistically significant improvements were observed in gait speed and mean step length. [Conclusion] Gait training using the Hybrid Assistive Limb is safe for patients with cerebral palsy and can produce immediate effects on walking ability in ambulatory patients with cerebral palsy.

Training with Hybrid Assistive Limb for walking function after total knee arthroplasty.

BACKGROUND: The Hybrid Assistive Limb (HAL, CYBERDYNE) is a wearable robot that provides assistance to patients while walking, standing, and performing leg movements based on the intended movement of the wearer. We aimed to assess the effect of HAL training on the walking ability, range of motion (ROM), and muscle strength of patients after total knee arthroplasty (TKA) for osteoarthritis and rheumatoid arthritis, and to compare the functional status after HAL training to the conventional training methods after surgery. METHODS: Nine patients (10 knees) underwent HAL training (mean age 74.1 ± 5.7 years; height 150.4 ± 6.5 cm; weight 61.2 ± 8.9 kg), whereas 10 patients (11 knees) underwent conventional rehabilitation (mean age 78.4 ± 8.0 years; height 150.5 ± 10.0 cm; weight 59.1 ± 9.8 kg). Patients underwent HAL training during 10 to 12 (average 14.4 min a session) sessions over a 4-week period, 1 week after TKA. There was no significant difference in the total physical therapy time including HAL training between the HAL and control groups. Gait speed, step length, ROM, and muscle strength were evaluated. RESULTS: The nine patients completed the HAL training sessions without adverse events. The walking speed and step length in the self-selected walking speed condition, and the walking speed in the maximum walking speed condition were greater in the HAL group than in the control group at 4 and 8 weeks (P < 0.05). The step length in the maximum walking speed condition was greater in the HAL group than in the control group at 2, 4, and 8 weeks (P < 0.05). The extension lag and knee pain were lower in the HAL group than in the control group at 2 weeks (P < 0.05). The muscle strength of knee extension in the HAL group was greater than that in the control group at 8 weeks (P < 0.05). CONCLUSION: HAL training after TKA can improve the walking ability, ROM, and muscle strength compared to conventional physical therapy for up to 8 weeks after TKA. Since the recovery of walking ability was earlier in the HAL group than in the control group and adverse events were not observed in this pilot study, HAL training after TKA can be considered a safe and effective rehabilitation intervention. TRIAL REGISTRATION: UMIN, UMIN000017623 . Registered 19 May 2015.

Robot-assisted training using Hybrid Assistive Limb® for cerebral palsy.

PURPOSE: The Hybrid Assistive Limb® (HAL®, CYBERDYNE) is a wearable robot that provides assistance to a patient while they are walking, standing, and performing leg movements based on the wearer's intended movement. The effect of robot-assisted training using HAL® for cerebral palsy (CP) is unknown. Therefore, we assessed the effect of robot-assisted training using HAL® on patients with CP, and compared walking and gross motor abilities between pre-intervention and post-intervention. METHODS: Six subjects with CP were included (mean age: 16.8 years; range: 13-24 years; Gross Motor Function Classification System levels II-IV: n = 1, 4, 1). Robot-assisted training using HAL® were performed 2-4 sessions per week, 20 min per session, within a 4 weeks period, 12 times in total. Outcome measures included gait speed, step length, cadence, single-leg support per gait cycle, hip and knee joint angle in stance, and swing phase per gait cycle, 6-minute walking distance (6 MD), physiological cost index (PCI), knee-extension strength, and Gross Motor Function Measure (GMFM). RESULTS: There were significant increases in self-selected walking speed (SWS), cadence during SWS and maximum walking speed (MWS), single-leg support per gait cycle, hip joint angle in the swing phase, 6 MD, and GMFM. In contrast, gait speed during MWS, step length during SWS and MWS, hip and knee joint angle in the stance phase, knee joint angle in the swing phase, PCI, and knee-extension strength generally improved, but not significantly. CONCLUSION: Robot-assisted training using HAL® may improve walking and gross motor abilities of patients with CP.

Use of Hybrid Assistive Limb (HAL®) for a postoperative patient with cerebral palsy: a case report.

BACKGROUND: The Hybrid Assistive Limb (HAL®) is an exoskeleton wearable robot suit that assists in voluntary control of knee and hip joint motion. There have been several studies on HAL intervention effects in stroke, spinal cord injury, and cerebral palsy. However, no study has investigated HAL intervention for patients with cerebral palsy after surgery. CASE PRESENTATION: We report a case of using HAL in a postoperative patient with cerebral palsy. A 15-year-old boy was diagnosed with spastic diplegia cerebral palsy Gross Motor Function Classification System level IV, with knee flection contracture, equinus foot, and paralysis of the right upper extremity with adduction contracture. He underwent tendon lengthening of the bilateral hamstrings and Achilles tendons. Although the flexion contractures of the bilateral knees and equinus foot improved, muscle strength decreased after the soft tissue surgery. HAL intervention was performed twice during postoperative months 10 and 11. Walking speed, stride, and cadence were increased after HAL intervention. Post HAL intervention, extension angles of the knee in stance phase and hip in the pre-swing phase were improved. In the gait cycle, the proportion of terminal stance in the stance and swing phase was increased. CONCLUSIONS: Hybrid Assistive Limb intervention for postoperative patients with cerebral palsy whose muscle strength decreases can enhance improvement in walking ability. Further studies are needed to examine the safety and potential application of HAL in this setting.

Immediate effects of a single session of robot-assisted gait training using Hybrid Assistive Limb (HAL) for cerebral palsy.

[Purpose] Robot-assisted gait training (RAGT) using Hybrid Assistive Limb (HAL, CYBERDYNE) was previously reported beneficial for stroke and spinal cord injury patients. Here, we investigate the immediate effect of a single session of RAGT using HAL on gait function for cerebral palsy (CP) patients. [Subjects and Methods] Twelve patients (average age: 16.2 ± 7.3 years) with CP received a single session of RAGT using HAL. Gait speed, step length, cadence, single-leg support per gait cycle, hip and knee joint angle in stance, and swing phase per gait cycle were assessed before, during, and immediately after HAL intervention. [Results] Compared to baseline values, single-leg support per gait cycle (64.5 ± 15.8% to 69.3 ± 12.1%), hip extension angle in mid-stance (149.2 ± 19.0° to 155.5 ± 20.1°), and knee extension angle in mid-stance (137.6 ± 20.2° to 143.1 ± 19.5°) were significantly increased immediately after intervention. Further, the knee flexion angle in mid-swing was significantly decreased immediately after treatment (112.0 ± 15.5° to 105.2 ± 17.1°). Hip flexion angle in mid-swing also decreased following intervention (137.2 ± 14.6° to 129.7 ± 16.6°), but not significantly. Conversely, gait speed, step length, and cadence were unchanged after intervention. [Conclusion] A single-time RAGT with HAL improved single-leg support per gait cycle and hip and knee joint angle during gait, therapeutically improving gait function in CP patients.

The Training Effect of Early Intervention with a Hybrid Assistive Limb after Total Knee Arthroplasty.

After total knee arthroplasty (TKA), it is important for patients to show early improvements in knee joint function and walking to regain independence in performing the activities of daily life. We conducted for 4 weeks an intervention one week after TKA using a hybrid assistive limb (HAL: unilateral leg type) as an exoskeleton robotic device to facilitate knee joint function and walking. The intervention improved the range of knee extension movement safely and without pain compared to preoperation. In addition, we found that training with the HAL improved walking ability, speed, and rate, as well as the time taken to perform the timed up and go (TUG) test compared to preoperation. The strength of the quadriceps muscle did not improve with training; however, the patient was able to induce a knee extensor moment during the initial stance phase, as measured by kinetics and kinematics, and these actions could be performed without pain. HAL training soon after TKA improved knee joint function in a 76-year-old patient who presented with OA of the knee. The improvements in knee extension lag and knee extensor moment allowed the patient to walk without pain and regain ADL in comparison with preoperation.

Effects of friction massage of the popliteal fossa on blood flow velocity of the popliteal vein.

[Purpose] Friction massage (friction) of the popliteal fossa is provided for the purpose of relieving pain related to circulatory disorders by improving venous flow in the lower legs. The purpose of this study is to verify the effects of enhancing the venous flow based on measuring the blood flow velocity of the popliteal vein before and after providing friction to the patients. [Subjects and Methods] Fifteen healthy male university students participated in the study. The Doppler ultrasonography (DU) was used to measure the blood flow velocity of the popliteal vein, in order to verify the effects of enhancing the venous flow by comparing the measured values before and after a friction massage. [Results] The result of comparing the blood flow velocity before and after providing friction showed that there was a significant increase after friction. [Conclusion] This study proved that friction to the popliteal fossa is effectively enhances venous flow by increasing the blood flow velocity in the popliteal vein.

Gait training of subacute stroke patients using a hybrid assistive limb: a pilot study.

Purpose To determine whether gait training with a hybrid assistive limb (HAL) as an exoskeleton robotic device was safe and could increase functional mobility and gait ability in subacute stroke patients. Methods The participants were eight patients with post-stroke hemiparesis whose walking impairment and gait recovery curves had plateaued. The intervention program was gait training using HAL and a walker for 20 min daily 5 days a week for 5 weeks. The 10-m maximum walking speed (MWS), self-selected walking speed (SWS) and 2-min-walk test (2MT) without HAL were used as primary outcome measures to determine the effects of training. The Berg Balance Scale (BBS), Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) and functional ambulation category (FAC) were assessed as secondary outcomes. These measures were assessed before and after the 5-week intervention program and were analyzed statistically using a paired t-test. Results All eight participants completed the intervention program with no adverse events. There were significant increases in MWS, SWS and 2MT. BBS, FMA and FAC also increased, but not significantly. Conclusion The new HAL exoskeleton robotic device was efficient and safe for improving motor function and gait in patients in the subacute stage after stroke. Implications for Rehabilitation Gait training using HAL will improve gait ability of individuals with post stroke. The HAL achieve intensive gait training without increase spasticity and abnormal gait pattern.

Gait training with Hybrid Assistive Limb enhances the gait functions in subacute stroke patients: A pilot study.

BACKGROUND: The robotic Hybrid Assistive Limb (HAL) provides motion according to the wearer's voluntary activity. HAL training effects on walking speed and capacity have not been clarified in subacute stroke. OBJECTIVES: To determine improvement in walking ability by HAL and the most effective improvement measure for use in future large-scale trials. METHODS: Sixteen first-ever hemiplegic stroke patients completed at least 20 sessions over 5 weeks. Per session, the experimental group received no more than 20 min of gait training with HAL (HT) and 40 min of conventional physiotherapy, whereas the control group received at least 60 min of conventional physiotherapy. Primary outcome was maximum walking speed (MWS). RESULTS: The change in MWS from baseline at week 5 was 11.6±10.6 m/min (HAL group) and 2.2±4.1 m/min (control group) (adjusted mean difference = 9.24 m/min, 95% confidence interval 0.48-18.01, P = 0.040). In HAL subjects there were significant increases in Self-selected walking speed (SWS; a secondary outcome) and in step length (a secondary outcome) at MWS and SWS compared with controls. CONCLUSIONS: HT improved walking speed in hemiplegic sub-acute stroke patients. In future, randomized controlled trials are needed to confirm the utility of HT.