Human-centered design of a novel soft exosuit for post-stroke gait rehabilitation.

BACKGROUND: Stroke remains a major cause of long-term adult disability in the United States, necessitating the need for effective rehabilitation strategies for post-stroke gait impairments. Despite advancements in post-stroke care, existing rehabilitation often falls short, prompting the development of devices like robots and exoskeletons. However, these technologies often lack crucial input from end-users, such as clinicians, patients, and caregivers, hindering their clinical utility. Employing a human-centered design approach can enhance the design process and address user-specific needs. OBJECTIVE: To establish a proof-of-concept of the human-centered design approach by refining the NewGait® exosuit device for post-stroke gait rehabilitation. METHODS: Using iterative design sprints, the research focused on understanding the perspectives of clinicians, stroke survivors, and caregivers. Two design sprints were conducted, including empathy interviews at the beginning of the design sprint to integrate end-users' insights. After each design sprint, the NewGait device underwent refinements based on emerging issues and recommendations. The final prototype underwent mechanical testing for durability, biomechanical simulation testing for clinical feasibility, and a system usability evaluation, where the new stroke-specific NewGait device was compared with the original NewGait device and a commercial product, Theratogs®. RESULTS: Affinity mapping from the design sprints identified crucial categories for stakeholder adoption, including fit for females, ease of donning and doffing, and usability during barefoot walking. To address these issues, a system redesign was implemented within weeks, incorporating features like a loop-backed neoprene, a novel closure mechanism for the shoulder harness, and a hook-and-loop design for the waist belt. Additional improvements included reconstructing anchors with rigid hook materials and replacing latex elastic bands with non-latex silicone-based bands for enhanced durability. Further, changes to the dorsiflexion anchor were made to allow for barefoot walking. Mechanical testing revealed a remarkable 10-fold increase in durability, enduring 500,000 cycles without notable degradation. Biomechanical simulation established the modularity of the NewGait device and indicated that it could be configured to assist or resist different muscles during walking. Usability testing indicated superior performance of the stroke-specific NewGait device, scoring 84.3 on the system usability scale compared to 62.7 for the original NewGait device and 46.9 for Theratogs. CONCLUSION: This study successfully establishes the proof-of-concept for a human-centered design approach using design sprints to rapidly develop a stroke-specific gait rehabilitation system. Future research should focus on evaluating the clinical efficacy and effectiveness of the NewGait device for post-stroke rehabilitation.

Rest the Brain to Learn New Gait Patterns after Stroke.

Background: The ability to relearn a lost skill is critical to motor recovery after a stroke. Previous studies indicate that stroke typically affects the processes underlying motor control and execution but not the learning of those skills. However, these prior studies could have been confounded by the presence of significant motor impairments and/or have not focused on motor acuity tasks (i.e., tasks focusing on the quality of executed actions) that have direct functional relevance to rehabilitation. Methods: Twenty-five participants (10 stroke; 15 controls) were recruited for this prospective, case-control study. Participants learned a novel foot-trajectory tracking task on two consecutive days while walking on a treadmill. On day 1, participants learned a new gait pattern by performing a task that necessitated greater hip and knee flexion during the swing phase of the gait. On day 2, participants repeated the task with their training leg to test retention. An average tracking error was computed to determine online and offline learning and was compared between stroke survivors and uninjured controls. Results: Stroke survivors were able to improve their tracking performance on the first day (p=0.033); however, the amount of learning in stroke survivors was lower in comparison with the control group on both days (p≤0.05). Interestingly, the offline gains in motor learning were higher in stroke survivors when compared with uninjured controls (p=0.011). Conclusions: The results suggest that even high-functioning stroke survivors may have difficulty acquiring new motor skills related to walking, which may be related to the underlying neural damage caused at the time of stroke. Furthermore, it is likely that stroke survivors may require longer training with adequate rest to acquire new motor skills, and rehabilitation programs should target motor skill learning to improve outcomes after stroke.

Applying elastic resistance bands for gait training: A simulation-based study to determine how band configuration affects gait biomechanics and muscle activation.

BACKGROUND: Wearable robotic exoskeletons and leg braces are desirable for gait rehabilitation because they can apply loads directly to an affected joint. Yet, they are not widely used in clinics because they are costly and complex to set up. Conversely, tethered devices, such as elastic resistance bands, are widely available in clinics, are low-cost, and are quick to set up. However, resistance bands will affect walking differently based on how they are configured to pull on the leg (e.g., pulling forward or backward). RESEARCH QUESTION: How can a resistance band be configured to alter muscle activation and gait biomechanics based on the segment it is attached to and the angle with which it attaches? METHODS: We used an open-source musculoskeletal modeling platform to emulate several configurations of an elastic band pulling on the ankle, calf, and thigh at various angles during non-pathological walking. We evaluated gait biomechanics and simulated muscle activation using computed muscle control (CMC) and identified a subset of four configurations with potential applications for gait training. Eight non-pathological participants then walked on a treadmill under these configurations to verify how these configurations altered muscle activation. RESULTS: We found that muscle activity greatly varied based on the location where the elastic band is attached and the angle with which the elastic band pulls on the leg. Notably, specific angles can be used to pull on the legs to elicit an increase or decrease in muscle activation. SIGNIFICANCE: This study provides insight into how tethered devices can be configured to provide assistance or resistance during gait training. This information can be applied when developing low-cost gait training solutions for addressing individuals' impairments.

Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial.

Aim: The Combining Mechanisms for Better Outcomes randomized controlled trial assessed the effectiveness of various spinal cord stimulation (SCS) modalities for chronic pain. Specifically, combination therapy (simultaneous use of customized sub-perception field and paresthesia-based SCS) versus monotherapy (paresthesia-based SCS) was evaluated. Methods: Participants were prospectively enrolled (key inclusion criterion: chronic pain for ≥6 months). Primary end point was the proportion with ≥50% pain reduction without increased opioids at the 3 month follow-up. Patients were followed for 2 years. Results: The primary end point was met (n = 89; p < 0.0001) in 88% of patients in the combination-therapy arm (n = 36/41) and 71% in the monotherapy arm (n = 34/48). Responder rates at 1 and 2 years (with available SCS modalities) were 84% and 85%, respectively. Sustained functional outcomes improvement was observed out to 2 years. Conclusion: SCS-based combination therapy can improve outcomes in patients with chronic pain. Clinical Trial Registration: NCT03689920 (ClinicalTrials.gov), Combining Mechanisms for Better Outcomes (COMBO).

Spinal cord stimulation (SCS) is a device-based therapy for chronic pain that delivers electrical impulses to the spinal cord, disrupting pain signals to the brain. Pain relief can be achieved using different SCS techniques that use or do not use paresthesia (stimulation that produces a tingling sensation). These approaches affect patients in different ways, suggesting that different biological processes are involved in enabling pain relief. Research also suggests that better long-term results occur when patients can choose the therapy that is best for their own needs. This clinical study compared pain relief and other functional activities in those receiving combination therapy (simultaneous use of SCS that does and does not produce tingling sensation) against those receiving monotherapy (only SCS therapy producing tingling sensation) for 3 months. In the study, 88% of those receiving combination therapy and 71% with monotherapy alone reported a 50% (or greater) decrease in overall pain (the 'responder rate') without an increased dose of opioid drugs at 3 months after the start of therapy. This responder rate was found to be 84% at 1 year and 85% at 2 years (with all SCS therapy options available). Analysis of functional activities or disability showed that patients improved from 'severely disabled' at study start to 'moderately disabled' after 2 years, indicating that effective long-term (2 year) improvement can be achieved using SCS-based combination therapy for chronic pain.

Functional Resistance Training Differentially Alters Gait Kinetics After Anterior Cruciate Ligament Reconstruction: A Pilot Study.

BACKGROUND: Quadriceps weakness is common after anterior cruciate ligament (ACL) reconstruction and can alter gait mechanics. Functional resistance training (FRT) is a novel approach to retraining strength after injury, but it is unclear how it alters gait mechanics. Therefore, we tested how 3 different types of FRT devices: a knee brace resisting extension (unidirectional brace), a knee brace resisting extension and flexion (bidirectional brace), and an elastic band pulling backwards on the ankle (elastic band)-acutely alter gait kinetics in this population. HYPOTHESIS: The type of FRT device will affect ground-reaction forces (GRFs) during and after the training. Specifically, the uni- and bidirectional braces will increase GRFs when compared with the elastic band. STUDY DESIGN: Crossover study. LEVEL OF EVIDENCE: Level 2. METHODS: A total of 15 individuals with ACL reconstruction received FRT with each device over 3 separate randomized sessions. During training, participants walked on a treadmill while performing a tracking task with visual feedback. Sessions contained 5 training trials (180 seconds each) with rest between. Vertical and anterior-posterior GRFs were assessed on the ACL-reconstructed leg before, during, and after training. Changes in GRFs were compared across devices using 1-dimensional statistical parametric mapping. RESULTS: Resistance applied via bidirectional brace acutely increased gait kinetics during terminal stance/pre-swing (ie, push-off), while resistance applied via elastic band acutely increased gait kinetics during initial contact/loading (ie, braking). Both braces behaved similarly, but the unidirectional brace was less effective for increasing push-off GRFs. CONCLUSION: FRT after ACL reconstruction can acutely alter gait kinetics during training. Devices can be applied to selectively alter gait kinetics. However, the long-term effects of FRT after ACL reconstruction with these devices are still unknown. CLINICAL RELEVANCE: FRT may be applied to alter gait kinetics of the involved limb after ACL reconstruction, depending on the device used.

Dynamic knee stiffness during walking is increased in individuals with anterior cruciate ligament reconstruction.

Individuals with anterior cruciate ligament (ACL) reconstruction often display abnormal gait mechanics reflective of a "stiff-knee" gait (i.e., reduced knee flexion angles and moments). However, dynamic knee stiffness, which is the dynamic relationship between the position of the knee and the moment acting on it, has not been directly examined during walking in individuals with ACL reconstruction. Here, we aimed to evaluate dynamic knee stiffness in the involved compared to the uninvolved limb during weight-acceptance and mid-stance phases of walking. Twenty-six individuals who underwent ACL reconstruction (Age: 20.2 ± 5.1 yrs., Time post-op: 7.2 ± 0.9 mo.) completed an overground walking assessment using a three-dimensional motion capture system and two force plates. Dynamic knee stiffness (Nm/°) was calculated as the slope of the regression line during weight-acceptance and midstance, obtained by plotting the sagittal plane knee angle versus knee moment. Paired t-tests with Bonferroni corrections were used to compare differences in dynamic stiffness, knee excursions, and moment ranges between limbs during both stance phases. Greater dynamic knee stiffness was found in the involved compared with the uninvolved limb during weight-acceptance and mid-stance (p < 0.01). Knee flexion and extension excursions were reduced in the involved limb during both weight-acceptance and mid-stance, respectively (p < 0.01). Sagittal plane knee moment ranges were not different between limbs during weight-acceptance (p = 0.1); however, the involved limb moment range was reduced relative to the uninvolved limb during mid-stance (p < 0.01). These results indicate that individuals with ACL reconstruction walk with a stiffer knee throughout stance, which may influence knee contact forces and could contribute to the high propensity for post-traumatic knee osteoarthritis development in this population.

Functional Resistance Training With Viscous and Elastic Devices: Does Resistance Type Acutely Affect Knee Function?

OBJECTIVE: Functional resistance training (FRT) during walking is an emerging approach for rehabilitating individuals with neuromuscular or orthopedic injuries. During FRT, wearable exoskeleton/braces can target resistance to a weakened leg joint; however, the resistive properties of the training depend on the type of resistive elements used in the device. Hence, this study was designed to examine how the biomechanical and neural effects of functional resistance training differ with viscous and elastic resistances during both treadmill and overground walking. METHODS: Fourteen able-bodied individuals were trained on two separate sessions with two devices that provided resistance to the knee (viscous and elastic) while walking on a treadmill. We measured gait biomechanics and muscle activation during training, as well as kinematic aftereffects and changes in peripheral fatigue and neural excitability after training. RESULTS: We found the resistance type differentially altered gait kinetics during training-elastic resistance increased knee extension during stance while viscous resistance primarily affected swing. Also, viscous resistance increased power generation while elastic resistance could increase power absorption. Both devices resulted in significant kinematic and neural aftereffects. However, overground kinematic aftereffects and neural excitability did not differ between devices. CONCLUSION: Different resistance types can be used to alter gait biomechanics during training. While there were no resistance-specific changes in acute neural adaptation following training, it is still possible that prolonged and repeated training could produce differential effects. SIGNIFICANCE: Resistance type alters the kinetics of functional resistance training. Prolonged and repeated training sessions on patients will be needed to further measure the effects of these devices.

Comparing the accuracy of open-source pose estimation methods for measuring gait kinematics.

BACKGROUND: Open-source pose estimation is rapidly reducing the costs associated with motion capture, as machine learning partially eliminates the need for specialized cameras and equipment. This technology could be particularly valuable for clinical gait analysis, which is often performed qualitatively due to the prohibitive cost and setup required for conventional, marker-based motion capture. RESEARCH QUESTION: How do open-source pose estimation software packages compare in their ability to measure kinematics and spatiotemporal gait parameters for gait analysis? METHODS: This analysis used an existing dataset that contained video and synchronous motion capture data from 32 able-bodied participants while walking. Sagittal plane videos were analyzed using pre-trained algorithms from four open-source pose estimation methods-OpenPose, Tensorflow MoveNet Lightning, Tensorflow MoveNet Thunder, and DeepLabCut-to extract keypoints (i.e., landmarks) and calculate hip and knee kinematics and spatiotemporal gait parameters. The absolute error when using each markerless pose estimation method was computed against conventional marker-based optical motion capture. Errors were compared between pose estimation methods using statistical parametric mapping. RESULTS: Pose estimation methods differed in their ability to measure kinematics. OpenPose and Tensorflow MoveNet Thunder methods were most accurate for measuring hip kinematics, averaging 3.7 ± 1.3 deg and 4.6 ± 1.8 deg (mean ± std) over the entire gait cycle, respectively. OpenPose was most accurate when measuring knee kinematics, averaging 5.1 ± 2.5 deg of error over the gait cycle. MoveNet Thunder and OpenPose had the lowest errors when measuring spatiotemporal gait parameters but were not statistically different from one another. SIGNIFICANCE: The results indicate that OpenPose significantly outperforms other existing platforms for pose-estimation of healthy gait kinematics and spatiotemporal gait parameters and could serve as an alternative to conventional motion capture systems in clinical and research settings when marker-based systems are not available.

Functional resistance training methods for targeting patient-specific gait deficits: A review of devices and their effects on muscle activation, neural control, and gait mechanics.

BACKGROUND: Injuries to the neuromusculoskeletal system often result in weakness and gait impairments. Functional resistance training during walking-where patients walk while a device increases loading on the leg-is an emerging approach to combat these symptoms. However, there are many methods that can be used to resist the patient, which may alter the biomechanics of the training. Thus, all methods may not address patient-specific deficits. METHODS: We performed a comprehensive electronic database search to identify articles that acutely (i.e., after a single training session) examined how functional resistance training during walking alters muscle activation, gait biomechanics, and neural plasticity. Only articles that examined these effects during training or following the removal of resistance (i.e., aftereffects) were included. FINDINGS: We found 41 studies that matched these criteria. Most studies (24) used passive devices (e.g., weighted cuffs or resistance bands) while the remainder used robotic devices. Devices varied on if they were wearable (14) or externally tethered, and the type of resistance they applied (i.e., inertial [14], elastic [8], viscous [7], or customized [12]). Notably, these methods provided device-specific changes in muscle activation, biomechanics, and spatiotemporal and kinematic aftereffects. Some evidence suggests this training results in task-specific increases in neural excitability. INTERPRETATION: These findings suggest that careful selection of resistive strategies could help target patient-specific strength deficits and gait impairments. Also, many approaches are low-cost and feasible for clinical or in-home use. The results provide new insights for clinicians on selecting an appropriate functional resistance training strategy to target patient-specific needs.

The MOTION Study: A Randomized Controlled Trial with Objective Real-World Outcomes for Lumbar Spinal Stenosis Patients Treated with the mild® Procedure: One-Year Results.

OBJECTIVE: The purpose of this study is to provide Level-1 objective, real-world outcome data for patients with lumbar spinal stenosis suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum. DESIGN: The MOTION Study is a prospective, multicenter, randomized controlled trial comparing the mild® Procedure (minimally invasive lumbar decompression; Vertos Medical, Aliso Viejo, CA, USA) as a first-line therapy in combination with nonsurgical conventional medical management (CMM) vs CMM alone as the active control. METHODS: Patients in the test group received the mild Procedure at baseline. Both the mild+CMM group and the control group were allowed unrestricted access to conventional real-world therapies. Patient-reported outcomes included the Oswestry Disability Index, the Zurich Claudication Questionnaire, and the Numeric Pain Rating Scale. A validated Walking Tolerance Test, the incidence of subsequent lumbar spine interventions, and the occurrence of adverse events were used to measure objective outcomes. RESULTS: Sixty-nine patients in each group were analyzed at 1-year follow-up. No device- or procedure-related adverse events were reported in either group. Results from all primary and secondary outcome measures showed statistical significance in favor of mild+CMM. CONCLUSIONS: One-year results of this Level-1 study demonstrated superiority of mild+CMM over CMM alone for patients with lumbar spinal stenosis who were suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum. Use of the validated Walking Tolerance Test to objectively measure increased ability to walk without severe symptoms provided evidence of statistically significantly better outcomes for mild+CMM than for CMM alone. With no reported device or procedure-related adverse events, the long-standing safety profile of the mild Procedure was reaffirmed. mild is a safe, durable, minimally invasive procedure that has been shown to be effective as an early interventional therapy for patients suffering from symptomatic lumbar spinal stenosis.

Motor slacking during resisted treadmill walking: Can visual feedback of kinematics reduce this behavior?

BACKGROUND: Functional resistance training is frequently applied to rehabilitate individuals with neuromusculoskeletal injuries. It is performed by applying resistance in conjunction with a task-specific training, such as walking. However, the benefits of this training may be limited by motor slacking, a phenomenon in which the human body attempts to reduce muscle activation levels or movement excursions to minimize metabolic- or movement-related costs. While kinematic feedback could reduce one's tendency to minimize effort during training, this has not been verified experimentally. RESEARCH QUESTION: Does functional resistance training during walking lead to motor slacking, and can techniques such as visual feedback be used to reduce these effects? METHODS: Fourteen able-bodied individuals participated in this experiment. Participants were trained by walking on a treadmill while a bidirectional resistance was applied to the knee using a robotic knee exoskeleton. During training, participants were either instructed to walk in a manner that felt natural or were provided real-time visual feedback of their kinematics. Electromyography and knee kinematics were measured to determine if adding resistance to the limb induced slacking and if feedback could reduce slacking behavior. Kinematic aftereffects were measured after training bouts to gauge adaptation. RESULTS: Functional resistance training without feedback significantly reduced knee flexion when compared to baseline walking, indicating that participants were slacking. This reduction in knee flexion did not improve with continued training. Providing visual feedback of knee joint kinematics during training significantly increased knee muscle activation and kinematic aftereffects. SIGNIFICANCE: The findings indicate that individuals are susceptible to motor slacking during functional resistance training, which could affect outcomes of this training. However, motor slacking can be reduced if training is provided in conjunction with a feedback paradigm. This finding underscores the importance of using additional methods that externally motivate motor adaptation when the body is not intrinsically motivated to do so.

Functional Resistance Training to Improve Knee Strength and Function After Acute Anterior Cruciate Ligament Reconstruction: A Case Study.

BACKGROUND: Thigh muscle weakness after anterior cruciate ligament reconstruction (ACLR) can persist after returning to activity. While resistance training can improve muscle function, "nonfunctional" training methods are not optimal for inducing transfer of benefits to activities such as walking. Here, we tested the feasibility of a novel functional resistance training (FRT) approach to restore strength and function in an individual with ACLR. HYPOTHESIS: FRT would improve knee strength and function after ACLR. STUDY DESIGN: Case report. LEVEL OF EVIDENCE: Level 5. METHODS: A 15-year-old male patient volunteered for an 8-week intervention where he performed 30 minutes of treadmill walking, 3 times per week, while wearing a custom-designed knee brace that provided resistance to the thigh muscles of his ACLR leg. Thigh strength, gait mechanics, and corticospinal and spinal excitability were assessed before and immediately after the 8-week intervention. Voluntary muscle activation was evaluated immediately after the intervention. RESULTS: Knee extensor and flexor strength increased in the ACLR leg from pre- to posttraining (130 to 225 N·m [+74%] and 44 to 88 N·m [+99%], respectively) and increases in between-limb extensor and flexor strength symmetry (45% to 92% [+74%] and 47% to 72% [+65%], respectively) were also noted. After the intervention, voluntary muscle activation in the ACLR leg was 72%, compared with the non-ACLR leg at 75%. Knee angle and moment during late stance phase decreased (ie, improved) in the ACLR leg and appeared more similar to the non-ACLR leg after FRT training (18° to 14° [-23.4] and 0.07 to -0.02 N·m·kg-1·m-1 [-122.8%], respectively). Corticospinal and spinal excitability in the ACLR leg decreased (3511 to 2511 [-28.5%] and 0.42 to 0.24 [-43.7%], respectively) from pre- to posttraining. CONCLUSION: A full 8 weeks of FRT that targeted both quadriceps and hamstring muscles lead to improvements in strength and gait, suggesting that FRT may constitute a promising and practical alternative to traditional methods of resistance training. CLINICAL RELEVANCE: FRT may serve as a viable approach to improve knee strength and function after ACL reconstruction.

Design and Preliminary Assessment of a Passive Elastic Leg Exoskeleton for Resistive Gait Rehabilitation.

OBJECTIVE: This article aimed to develop a unique exoskeleton to provide different types of elastic resistances (i.e., resisting flexion, extension, or bidirectionally) to the leg muscles during walking. METHODS: We created a completely passive leg exoskeleton, consisting of counteracting springs, pulleys, and clutches, to provide different types of elastic resistance to the knee. We first used a benchtop setting to calibrate the springs and validate the resistive capabilities of the device. We then tested the device's ability to alter gait mechanics, muscle activation, and kinematic aftereffects when walking on a treadmill under the three resistance types. RESULTS: Benchtop testing indicated that the device provided a nearly linear torque profile and could be accurately configured to alter the angle where the spring system was undeformed (i.e., the resting position). Treadmill testing indicated the device could specifically target knee flexors, extensors, or both, and increase eccentric loading at the joint. Additionally, these resistance types elicited different kinematic aftereffects that could be used to target user-specific spatiotemporal gait deficits. CONCLUSION: These results indicate that the elastic device can provide various types of targeted resistance training during walking. SIGNIFICANCE: The proposed elastic device can provide a diverse set of resistance types that could potentially address user-specific muscle weaknesses and gait deficits through functional resistance training.

Pain relief outcomes using an SCS device capable of delivering combination therapy with advanced waveforms and field shapes.

BACKGROUND: Given the range of subjective experiences reported by patients with chronic pain, Spinal Cord Stimulation (SCS) systems designed for tailored delivery of analgesic therapy may help improve treatment effectiveness and satisfaction. RESEARCH DESIGN AND METHODS: This case-series evaluated 420 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of neurostimulation (i.e. combination therapy) as well as multiple waveforms and/or field shapes. Following implantation, an array of standard programs (e.g. paresthesia-based SCS), and a custom set of sub-perception programs were provided per patient feedback. Pain scores (Numeric Rating Scale, NRS) were collected at baseline and during follow-up. RESULTS: In this multicenter, observational series (n = 420, 53.1% female; Age: 64.2 ± 13.4 years), a mean overall pain score of 7.2 ± 1.8 (SD) was reported pre-trial (Baseline). At a mean follow-up duration of 208 ± 200 (SD) days, the mean overall pain score reduced to 2.4 (p < 0.0001). Overall pain was reduced by 5.1 ± 2.4 and 4.5 ± 2.4 points (NRS) at 3-months (N = 256) and at 12-months post-implant (N = 122) respectively (p < 0.0001). CONCLUSIONS: These results suggest that highly 'customizable' SCS approaches may allow for highly effective pain relief within the real-world clinical setting.

Motor Modules are Impacted by the Number of Reaching Directions Included in the Analysis.

Muscle synergy analysis is commonly used to study how the nervous system coordinates the activation of a large number of muscles during human reaching. In synergy analysis, muscle activation data collected from various reaching directions are subjected to dimensionality reduction techniques to extract muscle synergies. Typically, muscle activation data are obtained only from a limited set of reaches with an inherent assumption that the performed reaches adequately represent all possible reaches. In this study, we investigated how the number of reaching directions included in the synergy analysis influences the validity of the extracted synergies. We used a musculoskeletal model to compute muscle activations required to perform 36 evenly spaced planar reaches. Nonnegative matrix factorization (NMF) and principal component analysis (PCA) were then used to extract reference synergies. We then selected several subsets of reaches and compared the ability of the extracted synergies from each subset to represent the muscle activation from all 36 reaches. We found that 6 reaches were required to extract valid synergies, and a further reduction in the number of reaches changed the composition of the resulting synergies. Further, we found that the choice of reaching directions included in the analysis for a given number of reaches also affected the validity of the extracted synergies. These findings indicate that both the number and the choice of reaching directions included in the analysis impacted the validity of the extracted synergies.

Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects.

OBJECTIVE: The WHISPER randomized controlled trial (RCT) evaluates safety and clinical effectiveness of subperception spinal cord stimulation (SCS) at ≤1.2 kHz in subjects previously implanted with an SCS system for treatment of chronic, neuropathic pain. METHODS: WHISPER is a prospective, multicenter RCT with a crossover design sponsored by Boston Scientific, Marlborough, MA (ClinicalTrials.gov: NCT02314000). Eligible subjects were randomized (N = 140) to receive subperception or supraperception for three months and then crossed over to receive the alternative. Upon completion of crossover period, subjects who preferred subperception were followed up to one year. Overall pain, quality-of-life, and other outcomes were collected in the study. The primary endpoint was the overall pain responder rate (≥50% improvement from baseline) with no increase in medications. Secondary endpoints consisted of pain scores, physical disability, quality of life, and treatment preference. RESULTS: The study met its primary endpoint and demonstrated noninferiority between supraperception and subperception in a prespecified cohort of 70 randomized subjects (Interim Analysis). Thirty-nine percent of subjects with subperception settings and 29% with supraperception settings had a greater than or equal to 50% reduction in their overall pain scores with no increase in average daily medication at three-months post-activation as compared with baseline. Further assessment of all participating study subjects (N = 140) revealed similar results. Subjects were previously implanted 3.8 ± 2 years and had a disability score (Oswestry Disability Index) of 70.2 ± 11.4 at study start. Of the randomized subjects that completed the End of Period 2 Visit, 93 (66%) preferred subperception SCS and their mean overall pain reduced from 7.3 ± 1.1 (N = 89) at baseline to 4.0 ± 2.1 (N = 80) at 12-months post-activation. Post hoc analysis also demonstrated that multiple options provide superior outcomes, as supported by a 74% increase in the responder rate when subjects could choose their most effective option (47%) compared with supraperception alone (27%). DISCUSSION: Subperception SCS at ≤1.2 kHz is safe and effective in subjects with extreme physical disability and previously implanted for chronic pain. Further, by providing study participants with different waveform options, increased pain relief was achieved.

Functional resistance training during walking: Mode of application differentially affects gait biomechanics and muscle activation patterns.

BACKGROUND: Task-specific loading of the limbs-termed as functional resistance training-is commonly used in gait rehabilitation; however, the biomechanical and neuromuscular effects of various forms of functional resistance training have not been studied systematically. This information is crucial for correctly selecting the appropriate mode of functional resistance training when treating individuals with gait disorders. RESEARCH QUESTION: To comprehensively evaluate the biomechanical (i.e., joint moment and power) and muscle activation changes with different forms of functional resistance training that are commonly used in clinics and research using biomechanical simulation-based analyses. METHODS: We developed simulations of functional resistance training during walking using OpenSim (Gait2354, 23 degrees of freedom and 54 muscles) and custom MATLAB scripts. We investigated five modes of functional resistance training that have been commonly used in clinics or in research: (1) a weight attached at the ankle, (2) an elastic band attached at the ankle, (3) a viscous device attached to the hip and knee, (4) a weight attached at the pelvis, and (5) a constant backwards pulling force at the pelvis. Lower-extremity joint moments and powers were computed using inverse dynamics and muscle activations were estimated using computed muscle control while walking with each device under multiple resistance levels: normal walking with no resistance, and walking with 30, 60, and 90 Newtons of resistance. RESULTS: The results indicate that the way in which resistance is applied during gait training differentially affects the internal joint moments, powers, and muscle activations as well as the joints and phase of the gait cycle where the resistance was experienced. SIGNIFICANCE: The results highlight the importance of understanding the joints and muscles that are targeted by various modes of functional resistance training and carefully choosing the best mode of training that meets the specific therapeutic needs of the patient.

Conditioning Brain Responses to Improve Quadriceps Function in an Individual With Anterior Cruciate Ligament Reconstruction.

BACKGROUND: Persistent quadriceps weakness and activation failure are common in individuals with anterior cruciate ligament (ACL) reconstruction. A growing body of evidence indicates that this chronic quadriceps dysfunction could be partly mediated due to reduced corticospinal excitability. However, current rehabilitation approaches do not directly target corticospinal deficits, which may be critical for restoring optimal clinical outcomes after the surgery. This case study tested the feasibility of operant conditioning of torque responses evoked by transcranial magnetic stimulation (TMS) to improve quadriceps function after ACL reconstruction. HYPOTHESIS: Operant conditioning of motor evoked torque responses would improve quadriceps strength, voluntary activation, and corticospinal excitability. STUDY DESIGN: Case study and research report. LEVEL OF EVIDENCE: Level 5. METHODS: A 24-year-old male with an ACL reconstruction (6 months postsurgery) trained for 20 sessions (2-3 times per week for 8 weeks) to increase his TMS-induced motor evoked torque response (MEP torque) of the quadriceps muscles using operant conditioning principles. Knee extensor strength, voluntary quadriceps muscle activation, and quadriceps corticospinal excitability were evaluated at 3 time points: preintervention (pre), 4 weeks (mid), and immediately after the intervention (post). RESULTS: The participant was able to successfully condition (ie, increase) the quadriceps MEP torque after 1 training session, and the conditioned MEP torque gradually increased over the course of 20 training sessions to reach about 500% of the initial value at the end of training. The participant's control MEP torque values and corticospinal excitability, which were measured outside of the conditioning paradigm, also increased with training. These changes were paralleled by improvements in knee extensor strength and voluntary quadriceps muscle activation. CONCLUSION: This study shows that operant conditioning of MEP torque is a feasible approach to improving quadriceps corticospinal excitability and quadriceps function after ACL reconstruction and encourages further testing in a larger cohort of ACL-reconstructed individuals. CLINICAL RELEVANCE: Operant conditioning may serve as a potential therapeutic adjuvant for ACL rehabilitation.

Learning new gait patterns is enhanced by specificity of training rather than progression of task difficulty.

The use of motor learning strategies may enhance rehabilitation outcomes of individuals with neurological injuries (e.g., stroke or cerebral palsy). A common strategy to facilitate learning of challenging tasks is to use sequential progression - i.e., initially reduce task difficulty and slowly increase task difficulty until the desired difficulty level is reached. However, the evidence related to the use of such sequential progressions to improve learning is mixed for functional skill learning tasks, especially considering situations where practice duration is limited. Here, we studied the benefits of sequential progression using a functional motor learning task that has been previously used in gait rehabilitation. Three groups of participants (N = 43) learned a novel motor task during treadmill walking using different learning strategies. Participants in the specific group (n = 21) practiced only the criterion task (i.e., matching a target template that was scaled-up by 30%) throughout the training. Participants in the sequential group (n = 11) gradually progressed to the criterion task (from 3% to 30% in increments of 3%), whereas participants in the random group (n = 11) started at 3% and progressed in random increments (involving both increases and decreases in task difficulty) to the criterion task. At the end of training, kinematic tracking performance on the criterion task was evaluated in all participants both with and without visual feedback. Results indicated that the tracking error was significantly lower in the specific group, and no differences were observed between the sequential and the random progression groups. The findings indicate that the amount of practice in the criterion task is more critical than the difficulty and variations of task practice when learning new gait patterns during treadmill walking.

A Portable Passive Rehabilitation Robot for Upper-Extremity Functional Resistance Training.

OBJECTIVE: Loss of arm function is common in individuals with neurological damage, such as stroke or cerebral palsy. Robotic devices that address muscle strength deficits in a task-specific manner can assist in the recovery of arm function; however, current devices are typically large, bulky, and expensive to be routinely used in the clinic or at home. This study sought to address this issue by developing a portable planar passive rehabilitation robot, PaRRo. METHODS: We designed PaRRo with a mechanical layout that incorporated kinematic redundancies to generate forces that directly oppose the user's movement. Cost-efficient eddy current brakes were used to provide scalable resistances. The lengths of the robot's linkages were optimized to have a reasonably large workspace for human planar reaching. We then performed theoretical analysis of the robot's resistive force generating capacity and steerable workspace using MATLAB simulations. We also validated the device by having a subject move the end-effector along different paths at a set velocity using a metronome while simultaneously collecting surface electromyography (EMG) and end-effector forces felt by the user. RESULTS: Results from simulation experiments indicated that the robot was capable of producing sufficient end-effector forces for functional resistance training. We also found the endpoint forces from the user were similar to the theoretical forces expected at any direction of motion. EMG results indicated that the device was capable of providing adjustable resistances based on subjects' ability levels, as the muscle activation levels scaled with increasing magnet exposures. CONCLUSION: These results indicate that PaRRo is a feasible approach to provide functional resistance training to the muscles along the upper extremity. SIGNIFICANCE: The proposed robotic device could provide a technological breakthrough that will make rehabilitation robots accessible for small outpatient rehabilitation centers and in-home therapy.