Effects of Single-Joint Type Hybrid Assistive Limb in Knee Rehabilitation on Reduction of Pre-motor Time and Increased Rate of Fast Muscle Activation for Anterior Cruciate Regiment (ACL) Reconstruction.

BACKGROUND/OBJECTIVES: Changes in muscle characteristics after post-anterior cruciate regiment (ACL) reconstruction are common. Knee robotic-assisted therapy using hybrid assistive limb (HAL) single-joint training for recovery from ACL injury has the potential to optimize muscle activity; however, its neurophysiological effects remain unclear. Thus, this study aimed to explore the electrophysiological parameters. METHODS: This prospective, nonrandomized, controlled trial was conducted between December 2021 and January 2024. The patients were divided into two groups: the HAL group and the control group, each including five patients who underwent arthroscopic ACL reconstruction. Knee HAL single-joint training was conducted once weekly for three sessions. Three electrophysiological measures were examined related to knee neuromuscular responses pre-motor time, peak amplitude time, and neuromuscular rate of electromyography rise (RER) using surface electromyography (EMG). The pre-motor time and peak amplitude time were assessed in both groups at each session pre- and post-intervention. Both groups were evaluated for RER at postoperative weeks 17 and 21. RESULTS: Regarding the interaction of pre-motor time within each group, the interaction of pre-motor time within each group, the effect size of vastus medialis (VM) was larger in the HAL group. The peak amplitude time of EMG, the overall estimated marginal means, and the HAL group exhibited a significant difference in the VM (p=0.019), while vastus lateralis (VL) showed no significant difference but a larger effect size (d=0.61). The RER revealed a significant difference in semitendinosus-RER30ms in the HAL group (p=0.044). CONCLUSIONS: The knee HAL training for post-ACL reconstruction patients may influence neurophysiological outcomes.

The Effectiveness of Warm-Up Using an Assistive Device in Wheelchair Basketball: A Feasibility Study of Able-Bodied Participants.

Introduction A warm-up is often performed to prevent injury and prepare for optimal performance. Nonetheless, research on its impact on performance, particularly in para-sports, remains limited. We hypothesized that the use of an assistive device during warm-up would enable wheelchair basketball players to perform full-body movements efficiently and effectively, contributing to enhanced wheelchair mobility. Therefore, this feasibility study aimed to assess the safety of warm-up exercise with an assistive device and the changes in wheelchair mobility performance before and after warm-up in able-bodied participants. Methods Thirteen able-bodied participants (nine males and four females; mean age: 34.3 ± 6.11 years) were analyzed. Warm-up consisted of a five-minute stand-up exercise using the lumbar-type Hybrid Assistive Limb®. Before and after warm-up, a 3-3-6 m sprint was performed as a wheelchair mobility performance test. The 3-3-6 m sprint is a test in which the athlete repeatedly accelerates, decelerates, and stops while driving at maximum effort for a total of 12 m (0-3 m, 3-6 m, and 6-12 m). The time required for the 3-3-6 m sprint and maximum instantaneous speed, acceleration time, deceleration time, hip joint angle, and average muscle activity of the lower limb and trunk muscles during the acceleration/deceleration phase of each section were compared before and after warm-up exercise. Results Warm-up with an assistive device was safe in healthy participants. The time required for the 3-3-6 m sprint was significantly reduced after the warm-up compared to that before the warm-up (p=0.005). Although not significant, there was a trend toward shorter deceleration times after the warm-up for participants herein. Conclusions In able-bodied participants, warm-up with an assistive device is safe; it may improve wheelchair mobility performance. Further research is required to determine its impact on para-athletes with disabilities.

Relationship between screen-play scenarios' effectiveness and player classification in elite wheelchair basketball based on match results of Tokyo 2020 Paralympic Games.

Background: The competitiveness of wheelchair basketball has increased over time. However, screen-play, considered a vital offensive tactic in running basketball, is still poorly clarified. Therefore, this study aimed to clarify the impact of screen-play on scoring and game results in wheelchair basketball and assess the roles of each player classification (PC). Methods: Information regarding screen-play, including 13 categories such as shot success, location, and PC, was recorded for 22 wheelchair basketball games in the Tokyo 2020 Paralympic Games. This information was analyzed using the chi-square test to evaluate the significant differences in the appearance frequency of variables in each category (categorical variable) between the winning and losing teams and the shot-success rate. Results: Except for PC-related categorical variables, comparing the appearance frequency of the winning and losing teams confirmed a significant difference for screen and pass locations (all p < 0.05). Regarding the shot-success rates of the winning and losing teams, a significant difference in five categories was confirmed, including shot and pass locations (all p < 0.05). Regarding the PC, comparing the appearance frequency of the winning and losing teams confirmed a significant difference for PC of the screener (p < 0.05). Significant differences were found in the shot-success rates of the winning and losing teams in nine, five, three, and four categories regarding the PCs of the shooter, user, screener, and passer, respectively, such as shot location, pass location, and type of screen (p < 0.05, respectively). Conclusion: In wheelchair basketball offenses, it may be effective to consider the following points in the scenario lead-up to a shot: Using two different spaces, in the paint and the 3-point field goal area, could be crucial in screen-play. Improving the accuracy of on-the-ball screen plays appears vital, and using off-the-ball screens could also contribute to winning. Allocating approximately 50% of screeners to the middle-point classification (Middle) players and the rest to the low-point (Low) and high-point (High) classification players, at approximately 25% each, may be practical. Regarding winning team player roles, using High shooters and users; Low, Middle, and High screeners; and Middle and High passers contributed to play success.

Do Stainless-Steel Pins Coated with Fibroblast Growth Factor-Calcium Phosphatase Composite Layers Have Anti-Infective Effects?

Background: The most problematic complication of external fixation is infection at the pin insertion site. Technology that improves the adhesion of the external fixation pin to the skin, subcutaneous tissue, and bone may prevent infection at the pin site. The purpose of this study is to formulate a calcium phosphate-fibroblast growth factor (Cp-FGF) coating on a stainless-steel external fixation pin and to verify its effectiveness in reducing infection at the pin site and its possible influence on bone fixation in animal experiments. Methods: We compared stainless-steel screws without coating (SS group; n = 32), those with a calcium phosphate coating (Cp group; n = 30), those with a Cp-FGF coating (FGF group; n = 32), and those with a Cp-FGF coating having enhanced biological activity (FGF+ group; n = 32) in male Japanese white domesticated rabbits. Screws were inserted percutaneously into the bilateral proximal tibial diaphysis of the rabbits and implanted for 4 weeks. Screws and periscrew tissue were observed postoperatively for qualitatively assessing infection. Results: Infection assessment by gross findings after 4 weeks (at screw removal) showed no significant differences between the groups. Histopathological evaluation of soft tissue infection and bone tissue infection showed no significant differences between the groups for either soft tissue or bone tissue. Since neither the FGF+ group nor the FGF group showed anti-infective effects, the biological activity of FGF is not the only determining factor. We compared SEM, XRD, coating detaching test, sustained release test, and bioassay to examine physicochemical properties among the coatings but found no sufficient differences. Conclusions: It is suggested that improving the tissue adhesion to and/or biocompatibility of pins is also important to improve the in vivo performance of Cp-FGF-coated external fixation pins.

Safety and Early Return to Sports for Early ACL Reconstruction in Young Athletes: A Retrospective Study.

Background and Objectives: Although previous reports have shown that early anterior cruciate ligament (ACL) reconstruction is associated with an increased risk of stiffness, recommendations for delayed surgery are based on outdated literature. The advent of arthroscopic surgery and accelerated rehabilitation protocols warrants a reexamination of the optimal surgical timing. The purpose of this study was to investigate complications during early ACL reconstruction after injury in young athletes. Materials and Methods: A total of 87 patients (27 males and 60 females) were included in this study. Patients who underwent anatomic ACL reconstruction using hamstring autografts were evaluated. Patients under 25 years of age with a Tegner activity score greater than 6 were included and classified into three groups according to the time from injury to surgical treatment: one week from injury to surgery (early group), three to six weeks from injury to surgery (normal group), and three to six months from injury to surgery (delayed group). We evaluated the rates of various complications such as graft rupture, contralateral injury, the need for manipulation for loss of ROM, infection, and fracture around the knee up to 2 years postoperatively. In addition, we investigated postoperative muscle strength, Lysholm score, Tegner activity score, and period of the return to sport from injury. Results: Patients in the delayed group were younger than those in the other groups (p = 0.009). Patients in the early group had a lower range of motion than those in the other groups preoperationly. However, the 1-month postoperative range of motion was comparable between groups. Patients in the early group had greater postoperative Tegner activity scores than those in the other groups. The period of return to sport from injury in the delayed group was longer than in the other groups. There were no statistically significant differences in the postoperative complication rate, muscle strength, or Lysholm score. Conclusions: ACL reconstruction performed 1 week from injury to surgery in young athletic patients indicated the rate of complications were not significantly different among the groups. Early ACL reconstruction with no postoperative complications may be related to early return to sports and a high level of sports.

Histological differences in cartilage layer growth at various tendon and ligament insertions in rabbits.

Objectives: Histological differences in cartilage layer growth in Achilles tendon (AT), quadriceps tendon (QT), patellar tendon (PT), and anterior cruciate ligament (ACL) insertion are unclear. Therefore, this study aimed to investigate the differences in cartilage layer growth in AT, QT, PT, and ACL insertions. Materials and Methods: Forty-eight male Japanese white rabbits were used. Six animals were euthanized at different stages (day 1 and 1, 2, 4, 6, 8, 12, and 24 weeks). Safranin O-stained glycosaminoglycan (GAG) production area, chondrocyte count, and insertion width were investigated. Results: A two-way analysis of variance (ANOVA) revealed a significant difference in the main effects of time and insertion for all parameters. In addition, the time × insertion interaction was significant. Multiple comparisons showed a significant difference between the ACL insertion and all other variables; however, the GAG production area was not significantly different for the QT, PT, and AT insertions. AT insertions were significantly different from all other groups; however, the number of chondrocytes and insertion width were not significantly different for ACL, QT, and PT insertions. Conclusion: Cartilage layer growth differed between the AT, QT, PT, and ACL insertions. The differences between the insertions may also be due to the differences in their structures, locations, and mechanical environments.

Morphologic changes in the posterior glenoid rim is independently associated with rotator cuff impingement in baseball players.

Background: The morphological changes in the posterior glenoid rim are unknown in relation to the area of rotator cuff tendons pinched within the glenohumeral joint in the throwing shoulders of baseball players. Therefore, this study aimed to clarify whether these changes are associated with the area of impingement in baseball players. Methods: Overall, 25 asymptomatic male college baseball players (average age19.8 years, 11.6 years of competing, and 50 shoulders) participated in this study. The area of impingement (AOI, mm2) and posterior glenohumeral distance (PGHD, mm) were measured using magnetic resonance imaging to quantitatively assess the impingement area of the rotator cuff tendon within the glenohumeral joint and the morphologic change in the posterior glenoid rim. These magnetic resonance imaging assessments were measured at 90° shoulder abduction with 90° and 100° external rotation. Multiple linear regression analysis was performed to determine whether AOI is predicted by PGHD. Findings: Multiple linear regression analysis showed that the PGHD was a predictor of the AOI at external rotation 90° (ß-coefficient = 0.738, R2 = 0.77, P < 0.001) and external rotation 100° position (ß-coefficient = 0.879, R2 = 0.76, P < 0.001). Interpretation: This study found that the area of impingement was associated with posterior glenohumeral distance. Therefore, these findings may indicate that complex shoulder joint morphologic changes result in a disabled throwing shoulder.

Potential of Titanium Pins Coated with Fibroblast Growth Factor-2-Calcium Phosphate Composite Layers to Reduce the Risk of Impaired Bone-Pin Interface Strength in the External Fixation of Distal Radius Fractures.

Background: The risk of impaired bone-pin interface strength in titanium (Ti) pins coated with fibroblast growth factor (FGF)-calcium phosphate (CP) composite layers is yet to be evaluated in a clinical study. This retrospective study used Weibull plot analysis to evaluate bone-pin interface strength in Ti pins coated with FGF-CP layers for external distal radius fracture fixation. Methods: The distal radial fractures were treated with external fixation. The FGF-CP group comprised five patients (all women, aged 70.4 ± 5.9 (range: 62-77) years), and the uncoated pin group comprised ten patients (eight women and two men, aged 64.4 ± 11.7 (range: 43-83) years). The pins were removed after six weeks. The insertion and extraction peak torques were measured. The extraction peak torque was evaluated using Weibull plot analysis. Results: We compared the extraction torque of the two groups at or below 506 Nmm for a fair comparison using Weibull plot analysis. The Weibull plots were linear for both the FGF-CP and uncoated pin groups. The slope of the regression line was significantly higher in the FGF-CP group (1.7343) than in the uncoated pin group (1.5670) (p = 0.011). The intercept of the regression line was significantly lower in the FGF-CP group (-9.847) than in the uncoated pin group (-8.708) (p = 0.002). Thus, the two regression lines significantly differed. Conclusions: Ti pins coated with FGF-CP layers exhibit the potential to reduce the risk of impaired bone-pin interface strength in the external fixation of distal radius fractures.

Acute and Long-Term Effects of Stretching with Whole-Body Vibration on Young's Modulus of the Soleus Muscle Measured Using Shear Wave Elastography.

The effect of whole-body vibration (WBV) stretching on soleus (SOL) muscle stiffness remains unclear. Therefore, we aimed to investigate the acute and long-term effects of stretching with WBV on SOL muscle stiffness. This study employed a repeated-measures experimental design evaluating 20 healthy young males. SOL muscle stretching with WBV was performed for 5 min per day (1 min per set, five sets) over 4 weeks, for 4 days a week. Participants stretched the SOL muscle with ankle dorsiflexion in a loaded flexed knee position on a WBV device. Data were obtained to examine acute effects before stretching, immediately after stretching, and at 5, 10, 15, and 20 min. Moreover, data were obtained to examine the long-term effects before stretching, immediately after the completion of the 4-week stretching program, and at 2 and 4 weeks later. SOL muscle stiffness was measured using Young's modulus with shear wave elastography. The acute effect of SOL muscle stretching with WBV persisted for up to 20 min. Additionally, the long-term effect of stretching was better maintained than the acute effect, which was effective for up to 4 weeks (p < 0.001). Clinically, continuous stretching with WBV may be used to improve SOL muscle stiffness in rehabilitation programs.

Rib cage contributions to inspiratory capacity in patients with cervical spinal cord injury.

Background: Cervical spinal cord injury (CSI) often leads to impaired respiratory function, affecting the overall well-being of patients. This study aimed to investigate the influence of rib cage motion on inspiratory capacity in CSI patients. Methods: We conducted a study with 11 CSI patients, utilising respiratory inductance plethysmography (RIP). We measured ventilatory volume by spirometry concurrently with RIP. Participants were instructed to perform maximal inspiratory efforts. Inspiratory capacity (IC) was calculated from spirometry waveforms. We converted the respiratory waveforms of the chest and abdomen into inspiratory volume measured by a spirometer. The inspiratory volume measured by the chest sensor was defined as VRIP-rib cage (VRIP-rc), and the inspiratory volume measured by the abdominal sensor was defined as VRIP-abdomen (VRIP-ab). Subsequently, the relationships of IC with VRIP-rc and VRIPab were assessed. Results: The mean IC was 1.828 ± 0.459 L, with the mean VRIP-rc at 1.343 ± 0.568 L and the mean VRIP-ab at 0.485 ± 0.427 L. A significant correlation was observed between IC and VRIP-rc (r = 0.67, p = 0.02), indicating that rib cage motion significantly influences IC in CSI patients. Conclusion: This study highlights the importance of rib cage motion in assessing inspiratory capacity in patients with CSI.

Association between Sarcopenia and Balance in Patients Undergoing Inpatient Rehabilitation after Hip Fractures: A Retrospective Cohort Study.

Background and Objectives: Sarcopenia is characterized by a decline in skeletal muscle mass, strength, and function and is associated with advancing age. This condition has been suggested as a factor that negatively influences the functional outcomes of patients with hip fractures. However, the association between sarcopenia and balance impairment in patients undergoing inpatient rehabilitation after hip fractures remains unclear. In this retrospective cohort study, we aimed to investigate the impact of sarcopenia on balance outcomes in patients undergoing inpatient rehabilitation following hip fractures. Materials and Methods: Baseline sarcopenia was diagnosed using skeletal muscle mass index and handgrip strength, with cut-off values recommended by the Asian Working Group for Sarcopenia. The primary outcome was balance, which was assessed using the Berg Balance Scale (BBS) at the time of discharge. A multiple linear regression model analyzed the association between sarcopenia and balance. The model was adjusted for age, sex, comorbidities, and cognitive function. Results: Among the 62 patients (mean age: 78.2; sex: 75.8% women), 24.2% had sarcopenia. Patients with sarcopenia had significantly lower BBS scores than did those without sarcopenia (41 vs. 49 points, p = 0.004). Multiple linear regression analysis revealed that baseline sarcopenia was independently associated with BBS scores at discharge (ß = -0.282, p = 0.038). Conclusions: Following inpatient rehabilitation, patients with baseline sarcopenia had inferior balance outcomes than did those without sarcopenia at discharge. Sarcopenia should be assessed on admission to consider and provide additional care for those with a higher risk of poor functional outcomes. More studies are needed to investigate the association between sarcopenia and functional outcomes, examine the impact of sarcopenia treatment on these outcomes, and reduce the risk of recurrent falls and fractures in patients with hip fractures.

Developing a Novel Prosthetic Hand with Wireless Wearable Sensor Technology Based on User Perspectives: A Pilot Study.

Myoelectric hands are beneficial tools in the daily activities of people with upper-limb deficiencies. Because traditional myoelectric hands rely on detecting muscle activity in residual limbs, they are not suitable for individuals with short stumps or paralyzed limbs. Therefore, we developed a novel electric prosthetic hand that functions without myoelectricity, utilizing wearable wireless sensor technology for control. As a preliminary evaluation, our prototype hand with wireless button sensors was compared with a conventional myoelectric hand (Ottobock). Ten healthy therapists were enrolled in this study. The hands were fixed to their forearms, myoelectric hand muscle activity sensors were attached to the wrist extensor and flexor muscles, and wireless button sensors for the prostheses were attached to each user's trunk. Clinical evaluations were performed using the Simple Test for Evaluating Hand Function and the Action Research Arm Test. The fatigue degree was evaluated using the modified Borg scale before and after the tests. While no statistically significant differences were observed between the two hands across the tests, the change in the Borg scale was notably smaller for our prosthetic hand (p = 0.045). Compared with the Ottobock hand, the proposed hand prosthesis has potential for widespread applications in people with upper-limb deficiencies.

Impact of Surgical Timing on Functional Outcomes after Anterior Cruciate Ligament Reconstruction.

Objectives: Although acute anterior cruciate ligament reconstruction (ACLR) is often avoided because of postoperative joint stiffness, delayed ACLR can lead to a longer recovery time and can have a negative impact on physical function due to detraining. This study aimed to determine the effects of acute ACLR on postoperative outcomes, including muscle strength, performance, and return to sports. Methods: A total of 110 patients who underwent anatomical ACLR using hamstring autografts were included in this study and were divided into three groups: acute (ACLR performed within 2 weeks after ACL injury), 2-6 weeks (ACLR performed between 2 and 6 weeks after injury), and 6-12 weeks (ACLR performed between 6 and 12 weeks after injury). Several parameters were evaluated, including range of motion, knee joint stability, isokinetic knee strength, performance, and return to sports. Results: No significant differences were found in the range of motion or knee joint stability between the groups. The acute group exhibited significantly greater quadriceps strength at 3 months postoperatively than the other groups (p < 0.05). The single-leg hop test showed that 66.7%, 38.7%, and 33.3% of the patients in the acute, 2-6 weeks, and 6-12 weeks groups, respectively, recovered to an LSI of 90% or greater (p = 0.09, Cramer's V = 0.27). All patients in the acute group were able to return to sports (p = 0.14; Cramer's V = 0.28). Conclusions: Acute ACLR is advantageous for the early recovery of strength and performance without adverse events. Acute ACLR may shorten the time spent away from sports activities.

Absolute reliability of Young's modulus of the soleus muscle and Achilles tendon measured using shear wave elastography in healthy young males.

Background: Stiffness of the soleus muscle (SOL) and Achilles tendon (AT) are associated with Achilles tendinitis and medial tibial stress syndrome. Therefore, reliable SOL and AT stiffness measurements are important for monitoring clinical progress. However, little is known about the absolute reliability of the stiffness measurements of SOL and AT in different ankle positions. This study aimed to determine the absolute reliability of the Young's modulus measurements of the SOL and AT in different ankle positions in healthy young males. Methods: This study included 33 healthy young males. SOL and AT stiffnesses were measured using Young's modulus and shear-wave elastography (SWE). Measurements were taken while the participants were kneeling, with their knees flexed to 90°, and the upper body supported by a table. Ultrasound images were recorded at ankle dorsiflexion angles of -10°, 0°, and 10°. The same measurements were repeated 15 min after the first measurement. Bland-Altman plots were used to verify the type or amount of error and 95 % confidence interval of the minimal detectable change (MDC95) values of the measurements. Results: Bland-Altman plots identified that there was no fixed or proportional bias and that there was good agreement between the first- and second-time measurements of the SOL and AT, respectively, among all angles. The MDC95 of the Young's modulus of SOL at -10°, 0°, and 10° of ankle dorsiflexion were 5.6 kPa, 7.0 kPa, and 10.1 kPa, respectively, and AT were 15.8 kPa, 16.4 kPa, and 17.8 kPa, respectively. Conclusion: Young's modulus measurements of the SOL and AT using SWE can be used to quantify elastic properties with high confidence. Clinically, assessing changes in the Young's moduli of the SOL and AT using SWE may help determine the effectiveness of interventions.

Association between Obesity and Short-Term Patient-Reported Outcomes following Total Knee Arthroplasty: A Retrospective Cohort Study in Japan.

Background: This study investigated the association between obesity and short-term patient-reported outcomes after total knee arthroplasty (TKA). Methods: The primary outcomes were the Western Ontario and McMaster Universities Osteoarthritis Index's (WOMAC) pain and function scores. Data were collected preoperatively and 2 and 4 weeks after surgery. Patients were stratified into three groups based on body mass index (BMI): normal weight (BMI < 24.99 kg/m2), overweight (25 ≤ BMI < 29.99 kg/m2), and obese (BMI ≥ 30 kg/m2). The associations between BMI and the WOMAC pain and function scores were assessed using generalized linear mixed models. Results: Among the 102 patients (median age: 75.0, women [85.3%]), 29.4%, 48.0%, and 22.5% were normal weight, overweight, and obese, respectively. The mean pain and function scores at baseline were similar across the BMI-stratified groups (p = 0.727 and 0.277, respectively). The pain score significantly improved 2 weeks post-surgery (p = 0.001). The function score improved significantly 4 weeks post-surgery (p < 0.001). The group and group-by-time interaction effects lacked statistical significance. Conclusions: All patients statistically and clinically showed relevant pain reduction and functional improvement shortly after TKA, irrespective of their obesity status. These data may help healthcare professionals discuss the expectations of pain amelioration and functional improvement with TKA candidates.

Femtosecond Laser Irradiation to Zirconia Prior to Calcium Phosphate Coating Enhances Osteointegration of Zirconia in Rabbits.

Calcium phosphate (CaP) coating of zirconia and zirconia-based implants is challenging, due to their chemical instability and susceptibility to thermal and mechanical impacts. A 3 mol% yttrium-stabilized tetragonal zirconia polycrystal was subjected to femtosecond laser (FsL) irradiation to form micro- and submicron surface architectures, prior to CaP coating using pulsed laser deposition (PLD) and low-temperature solution processing. Untreated zirconia, CaP-coated zirconia, and FsL-irradiated and CaP-coated zirconia were implanted in proximal tibial metaphyses of male Japanese white rabbits for four weeks. Radiographical analysis, push-out test, alizarin red staining, and histomorphometric analysis demonstrated a much improved bone-bonding ability of FsL-irradiated and CaP-coated zirconia over CaP-coated zirconia without FsL irradiation and untreated zirconia. The failure strength of the FsL-irradiated and CaP-coated zirconia in the push-out test was 6.2-13.1-times higher than that of the CaP-coated zirconia without FsL irradiation and untreated zirconia. Moreover, the adhesion strength between the bone and FsL-irradiated and CaP-coated zirconia was as high as that inducing host bone fracture in the push-out tests. The increased bone-bonding ability was attributed to the micro-/submicron surface architectures that enhanced osteoblastic differentiation and mechanical interlocking, leading to improved osteointegration. FsL irradiation followed by CaP coating could be useful for improving the osteointegration of cement-less zirconia-based joints and zirconia dental implants.

Gait training using a wearable robotic hip device for incomplete spinal cord injury: A preliminary study.

CONTEXT/OBJECTIVE: To explore changes in gait functions for patients with chronic spinal cord injury (SCI) before and after standard rehabilitation and rehabilitation with a wearable hip device, explore the utility of robot-assisted gait training (RAGT), and evaluate the safety and dose of RAGT. DESIGN: Single-arm, open-label, observational study. SETTING: A rehabilitation hospital. PARTICIPANTS: Twelve patients with SCI. INTERVENTIONS: Standard rehabilitation after admission in the first phase. RAGT for two weeks in the second phase. OUTCOME MEASURES: Self-selected walking speed (SWS), step length, cadence, and the 6-minute walking distance were the primary outcomes. Walking Index for SCI score, lower extremity motor score, and spasticity were measured. Walking abilities were compared between the two periods using a generalized linear mixed model (GLMM). Correlations between assessments and changes in walking abilities during each period were analyzed. RESULTS: After standard rehabilitation for 66.1 ± 36.9 days, a period of 17.6 ± 3.3 days of RAGT was safely performed. SWS increased during both periods. GLMM showed that the increase in cadence was influenced by standard rehabilitation, whereas the limited step length increase was influenced by RAGT. During RAGT, the increase in step length was related to an increase in hip flexor function. CONCLUSIONS: Gait speed in patients with SCI increased after rehabilitation, including RAGT, in the short-term. This increase was associated with improved muscle function in hip flexion at the start of RAGT.Trial Registration: This study was registered with the UMIN Clinical Trials Registry (UMIN-CTR; UMIN000042025).

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.

Muscle Strength and Efficiency of Muscle Activities Recovery Using Single-Joint Type Hybrid Assistive Limb in Knee Rehabilitation after Anterior Cruciate Ligament Reconstruction.

Decreased muscle strength often occurs after anterior cruciate ligament (ACL) reconstruction; this can include muscle atrophy, neuromuscular dysfunction, and reduced force generation efficiency. Hybrid assistive limb (HAL) technology, which integrates an interactive biofeedback system connecting the musculoskeletal system to the brain and spinal motor nerves, offers a potential intervention. Our study, conducted from March 2018 to August 2023 using knee HAL single-joint technology, was a prospective non-randomized controlled trial involving 27 patients who had undergone arthroscopic ACL reconstruction. They were split into two groups: HAL (18 patients) and control (nine patients). Beginning 18 weeks after their surgery, the HAL group participated in three weekly sessions of knee HAL-assisted exercises. Both the HAL and control groups underwent isokinetic muscle strength tests at postoperative weeks 17 and 21. Testing utilized an isokinetic dynamometer at 60°/s, 180°/s, and 300°/s. The Limb Symmetry Index (LSI) was employed to measure side-to-side differences. The HAL group showed significant LSI improvements in peak extension torque across all testing velocities and for peak flexion torque at 60°/s and 300°/s. The rate of change in LSI for peak flexion torque at 300°/s was significantly higher post-measurements (p = 0.036; effect size = 1.089). The change rate for LSI in peak extension torque at 300°/s and all peak flexion torques showed medium to large effect sizes in Cohen's d. In conclusion, knee HAL single-joint training positively influenced muscle strength recovery and efficiency. The HAL training group exhibited superior muscle strength at various isokinetic testing velocities compared to the control group.

Anatomical Single-Bundle Anterior Cruciate Ligament Reconstruction Using a Calcium Phosphate-Hybridized Tendon Graft with More than an Average of 5 Years of Follow-Up: A Follow-Up Study of a Randomized Controlled Trial.

Calcium phosphate (CaP)-hybridized tendon grafting using an alternate soaking process improves tendon-to-bone healing in anterior cruciate ligament (ACL) reconstructions. This study aimed to compare bone tunnel enlargement, knee osteoarthritis, and clinical results between CaP-hybridized tendon grafting and conventional grafting in anatomical single-bundle ACL reconstruction. This study was a follow-up of a randomized controlled trial. Between July 2011 and December 2015, 90 patients underwent unilateral anatomical single-bundle ACL reconstructions and were randomly assigned to the CaP-hybridized tendon grafting (CaP group, n = 45; age, 27.1 [14-54] years; sex, 21 males and 24 females) or conventional grafting (control group, n = 45; age, 22.9 [13-58] years; sex, 26 males and 19 females). The randomization was performed according to the days of the week when the patients first visited the outpatient. The CaP-hybridized tendon grafting was created intraoperatively. The tendon grafts were soaked in a calcium solution for 30 s. After that, the tendon grafts were soaked in a NaHPO4 solution for 30 s. This soaking cycle between the calcium solution and the NaHPO4 solution was repeated 10 times. The bone tunnel enlargement, osteoarthritis grade, clinical score, and sports level were evaluated in patients who could be followed up for >3 years (CaP group, n = 20, average follow-up period 6.0 [5.1-6.9] years; control group, n = 15, average follow-up period 5.6 [4.3-6.9] years). Clinical scores, sports levels, and osteoarthritis grades were analyzed using a generalized linear mixed model (GLMM) based on repeated measurement data from preoperative and final observations, with time, group, sex, age, and BMI as fixed effects and the effect of individual differences as variable effects. In addition, bone-tunnel enlargements were analyzed using generalized linear models (GLM) with group, sex, age, and BMI as the main effects. Compared with the control group, the CaP group exhibited significantly reduced bone-tunnel enlargement on the femoral side (anteroposterior diameter; CaP group, 7.9% [-1.1-16.8] vs. control group, 29.2% [17.9-40.5], p = 0.004, MCID 16.05, proximal-distal diameter; CaP group, 7.9% [-1.9-17.8] vs. control group, 22.8% [10.9-34.7], p = 0.062, MCID 15.00). The osteoarthritis grades progressed in both groups (p < 0.001). The clinical scores and sports levels were not significantly different between the groups. This study suggests that the calcium phosphate-hybridized tendon graft reduces femoral bone-tunnel enlargement after anatomical single-bundle anterior cruciate ligament reconstruction in an average >5-year follow-up period. A longer follow-up period is necessary to reveal the clinical effects of the calcium phosphate-hybridized tendon grafts in anterior cruciate ligament reconstruction.