Gait training using a hybrid assistive limb after botulinum toxin treatment for cerebral palsy: a case report.

[Purpose] Hybrid Assistive Limb® (HAL; Cyberdyne, Tsukuba, Japan) is a wearable robot that assists patients based on their voluntary movements. We report gait training with HAL after botulinum toxin treatment for spasticity of the lower limb in cerebral palsy (CP). [Participant and Methods] The participant was a 36 year-old male with spastic diplegia due to periventricular leukomalacia, with Gross Motor Function Classification System (GMFCS) level II. HAL training was performed in 20-minute sessions (3 sessions/week for 4 weeks). The outcome measures were range of motion, spasticity, walking ability, muscle strength, gross motor function measure (GMFM), Canadian Occupational Performance Measure (COPM), and Pediatric Evaluation of Disability Inventory measured before, immediately after, and one, two, and three months after HAL training. [Results] No adverse events were observed during training. After the HAL intervention, gait speed, step length, cadence, 6-min walking distance (6MD), knee extension strength, GMFM, and COPM increased, and Physiological Cost Index declined. Three months post-intervention, gait speed, step length, cadence, 6MD, and GMFM remained higher than those observed within the first two months. [Conclusion] Gait training with HAL can be a safe and feasible method for patients with CP who undergo botulinum toxin treatment to improve walking ability and motor function.

Effect of the Hybrid Assistive Limb on the Gait Pattern for Cerebral Palsy.

Background and objectives: Cerebral palsy (CP) is the most frequent childhood motor disability. Achieving ambulation or standing in children with CP has been a major goal of physical therapy. Recently, robot-assisted gait training using the Hybrid Assistive Limb® (HAL) has been effective in improving walking ability in patients with CP. However, previous studies have not examined in detail the changes in gait pattern after HAL training for patients with spastic CP, including gait symmetry. This study aimed to evaluate the immediate effect of HAL training on the walking ability and the changes in gait pattern and gait symmetry in patients with spastic CP. Materials and Methods: We recruited 19 patients with spastic CP (13 male and six female; mean age, 15.7 years). Functional ambulation was assessed using the 10-Meter Walk Test and gait analysis in the sagittal plane before and after a single 20-min HAL intervention session. Results: The walking speed and stride length significantly increased after HAL intervention compared to the pre-intervention values. Two-dimensional gait analysis showed improvement in equinus gait, increase in the flexion angle of the swing phase in the knee and hip joints, and improvement in gait symmetry. Immediate improvements in the walking ability and gait pattern were noted after HAL training in patients with spastic CP. Conclusions: The symmetry of the joint angle of the lower limb, including the trunk, accounts for the improvement in walking ability after HAL therapy.

Benefits of a Wearable Cyborg HAL (Hybrid Assistive Limb) in Patients with Childhood-Onset Motor Disabilities: A 1-Year Follow-Up Study.

Rehabilitation robots have shown promise in improving the gait of children with childhood-onset motor disabilities. This study aimed to investigate the long-term benefits of training using a wearable Hybrid Assistive Limb (HAL) in these patients. Training using a HAL was performed for 20 min a day, two to four times a week, over four weeks (12 sessions in total). The Gross Motor Function Measure (GMFM) was the primary outcome measure, and the secondary outcome measures were gait speed, step length, cadence, 6-min walking distance (6MD), Pediatric Evaluation of Disability Inventory, and Canadian Occupational Performance Measure (COPM). Patients underwent assessments before the intervention, immediately after the intervention, and at 1-, 2-, 3-month and 1-year follow-ups. Nine participants (five males, four females; mean age: 18.9 years) with cerebral palsy (n = 7), critical illness polyneuropathy (n = 1), and encephalitis (n = 1) were enrolled. After training using HAL, GMFM, gait speed, cadence, 6MD, and COPM significantly improved (all p < 0.05). Improvements in GMFM were maintained one year after the intervention (p < 0.001) and in self-selected gait speed and 6MD three months after the intervention (p < 0.05). Training using HAL may be safe and feasible for childhood-onset motor disabilities and may maintain long-term improvements in motor function and walking ability.

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.

Voluntary-assisted Upper Limb Training for Severe Cerebral Palsy Using Robotics Devices and Neuromuscular Electrical Stimulation: Three Case Reports.

Background: Constraint-induced movement therapy (CIMT) improves the motor function of paralyzed upper limbs of adults after stroke. However, in patients with severe spastic cerebral palsy (CP), the use of CIMT is not warranted. Our aim was to investigate the feasibility and effectiveness of repetitive voluntary-assisted upper limb training (VAUT) for three patients with severe CP using a combination of robotics [Hybrid Assistive Limb (HAL)] and functional electrical stimulation [Integrated Volitional Control Electrical Stimulation (IVES)]. Case: Three patients with CP were enrolled. Patients 1, 2, and 3 were 8-, 19-, and 18-year-old males, respectively. Patient 1 had spastic hemiplegia, while patients 2 and 3 had spastic quadriplegia. VAUT using single-joint HAL was performed for 1 or 2 sessions/month for 50 min/session over an 8-month period for 9-13 sessions in total. One patient's voluntary hand movement was insufficient, affecting his upper limb exercise performance; therefore, IVES was required in addition to HAL. Outcome measures included motor function of the upper limbs and use of paralyzed hands, which were measured before and after intervention. No adverse events were observed during VAUT. After intervention, the Action Research Arm Test scores showed improvements in all three patients. The Children's Hand-use Experience Questionnaire showed improvements in two patients. Discussion: The use of VAUT, together with new systems such as HAL and IVES, for severe CP is safe and may be effective. Our study suggested that upper limb function can be improved for patients with severe CP.

Short-Term Outcome of Rehabilitation Program with Hybrid Assistive Limb after Tendon Lengthening in Patients with Cerebral Palsy.

In this study, we aimed to evaluate the short-term outcomes of a rehabilitation program with the Hybrid Assistive Limb® after soft tissue lengthening in young patients with cerebral palsy. We assessed six patients with cerebral palsy who underwent soft tissue surgery followed by gait training using the Hybrid Assistive Limb®. Clinical assessments were conducted preoperatively, before, immediately after, and at 1, 2, and 3 months after gait training. Gross Motor Function Measure was improved 5.93 ± 6.11% (mean ± standard deviation, p < 0.05), Canadian Occupational Performance Measure performance was improved 3.12 ± 1.53 points, and satisfaction was improved 3.80 ± 2.14 points (p < 0.05). The knee extension strength on the operated side was changed 7.75 ± 4.97 Nm after the intervention (p = 0.07). In ambulatory patients, gait speed was changed 8.37 ± 1.72 m/min, stride length was changed 10 ± 6.16 cm, and 6 min walking distance was changed 52 ± 16 m after the intervention. Training with the Hybrid Assistive Limb® may improve walking ability and clinical outcomes in young patients with cerebral palsy after soft tissue lengthening.

Robot-assisted gait training using a very small-sized Hybrid Assistive Limb® for pediatric cerebral palsy: A case report.

PURPOSE: Gait parameters and gross motor function improve after 12 sessions of small-sized Hybrid Assistive Limb® (S-HAL) training in adult cerebral palsy (CP) patients. However, there are no reports on repetitive robot-assisted gait training using the newly developed very small-sized HAL (2S-HAL). This study aimed to examine the effect of using 2S-HAL on a pediatric CP patient. METHODS: The subject was an 11-year-old boy (height = 138 cm, weight = 30 kg) with spastic quadriplegia due to periventricular leukomalacia, with Gross Motor Function Classification System level IV. HAL training was performed for 2-4 sessions/week for 20 min/session (i.e., 4-week period with 12 sessions). Outcome measures were walking ability, gross motor function, Canadian Occupational Performance Measure (COPM), and Pediatric Evaluation of Disability Inventory measured before, after, and at 1, 2, and 3 months after HAL-assisted gait training. RESULTS: After HAL intervention, gait speed, step length, cadence, 6-min walking distance (6MD), Gross Motor Function Measure (GMFM), and COPM increased and physiological cost index (PCI) declined compared to those before intervention. The peaks of gait speed, step length, and cadence were 2 month, 1 month, and 3 month, respectively. 6MD, PCI, and GMFM at 1-3 months post-intervention were maintained. COPM peaked at 1 month post-intervention but remained higher than that before intervention. CONCLUSION: This is the first report of repetitive intervention using 2S-HAL in a pediatric CP patient. Gait training using 2S-HAL may be effective in CP patients as it improves post-training walking ability and gross motor function.