Development and deployment of cyclical focal muscle vibration system to improve walking performance in multiple sclerosis.

Vibration, a potent mechanical stimulus for activating muscle spindle primary afferents, may improve gait performance in persons with multiple sclerosis (MS), but has yet to be developed and deployed for multiple leg muscles with application during walking training. This study explored the development of a cyclic focal muscle vibration (FMV) system, and the deployment feasibility to correct MS walking swing phase deficits in order to determine whether this intervention warrants comprehensive study. The system was deployed during twelve, two-hour sessions of walking with cyclic FMV over six weeks. Participants served as their own control. Blood pressure, heart rate, walking speed, kinematics (peak hip, knee and ankle angles during swing), toe clearance, and step length were measured before and after deployment with blood pressure and heart rate monitored during deployment. During system deployment, there were no untoward sensations and physiological changes in blood pressure and heart rate, and volitional improvements were found in walking speed, improved swing phase kinematics, toe clearance and step length. This FMV training system was developed and deployed to improve joint flexion during walking in those with MS, and it demonstrated feasibility and benefits. Further study will determine the most effective vibration frequency and dose, carryover effects, and those most likely to benefit from this intervention.

Effect of Context-Dependent Modulation of Trunk Muscle Activity on Manual Wheelchair Propulsion.

OBJECTIVE: The aims of the study were to reliably determine the two main phases of manual wheelchair propulsion via a simple wearable sensor and to evaluate the effects of modulated trunk and hip stimulation on manual wheelchair propulsion during the challenging tasks of ramp assent and level sprint. DESIGN: An offline tool was created to identify common features between wrist acceleration signals for all subjects who corresponded to the transitions between the contact and recovery phases of manual wheelchair propulsion. For one individual, the acceleration rules and thresholds were implemented for real-time phase-change event detection and modulation of stimulation. RESULTS: When pushing with phase-dependent modulated stimulation, there was a significant (P < 0.05) increase in the primary speed variable (5%-6%) and the subject rated pushing as "moderately or very easy." In the offline analysis, the average phase-change event detection success rate was 79% at the end of contact and 71% at the end of recovery across the group. CONCLUSIONS: Signals from simple, wrist-mounted accelerometers can detect the phase transitions during manual wheelchair propulsion instead of elaborate and expensive, instrumented systems. Appropriately timing changes in muscle activation with the propulsion cycle can result in a significant increase in speed, and the system was consistently perceived to be significantly easier to use.

Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up.

OBJECTIVE: To quantify the long-term (>2y) effects of lower extremity (LE) neuroprostheses (NPs) for standing, transfers, stepping, and seated stability after spinal cord injury. DESIGN: Single-subject design case series with participants acting as their own concurrent controls, including retrospective data review. SETTING: Hospital-based clinical biomechanics laboratory with experienced (>20y in the field) research biomedical engineers, a physical therapist, and medical monitoring review. PARTICIPANTS: Long-term (6.2±2.7y) at-home users (N=22; 19 men, 3 women) of implanted NPs for trunk and LE function with chronic (14.4±7.1y) spinal cord injury resulting in full or partial paralysis. INTERVENTIONS: Technical and clinical performance measurements, along with user satisfaction surveys. MAIN OUTCOME MEASURES: Knee extension moment, maximum standing time, body weight supported by lower extremities, 3 functional standing tasks, 2 satisfaction surveys, NP usage, and stability of implanted components. RESULTS: Stimulated knee extension strength and functional capabilities were maintained, with 94% of implant recipients reporting being very or moderately satisfied with their system. More than half (60%) of the participants were still using their implanted NPs for exercise and function for >10min/d on nearly half or more of the days monitored; however, maximum standing times and percentage body weight through LEs decreased slightly over the follow-up interval. Stimulus thresholds were uniformly stable. Six-year survival rates for the first-generation implanted pulse generator (IPG) and epimysial electrodes were close to 90%, whereas those for the second-generation IPG along with the intramuscular and nerve cuff electrodes were >98%. CONCLUSIONS: Objective and subjective measures of the technical and clinical performances of implanted LE NPs generally remained consistent for 22 participants after an average of 6 years of unsupervised use at home. These findings suggest that implanted LE NPs can provide lasting benefits that recipients value.

Surface peroneal nerve stimulation in lower limb hemiparesis: effect on quantitative gait parameters.

OBJECTIVE: The objective of this study was to evaluate possible mechanisms for functional improvement and compare ambulation training with surface peroneal nerve stimulation vs. usual care via quantitative gait analysis. DESIGN: This study is a randomized controlled clinical trial. SETTING: The setting of this study is a teaching hospital of an academic medical center. PARTICIPANTS: One hundred ten chronic stroke survivors (>12 wks poststroke) with unilateral hemiparesis participated in this study. INTERVENTIONS: The subjects were randomized to a surface peroneal nerve stimulation device or usual care intervention. The subjects were treated for 12 wks and followed up for 6-mo posttreatment. MAIN OUTCOME MEASURES: Spatiotemporal, kinematic, and kinetic parameters of gait were the main outcome measures. RESULTS: Cadence (F3,153 = 5.81, P = 0.012), stride length (F3,179 = 20.01, P < 0.001), walking speed (F3,167 = 18.2, P < 0.001), anterior-posterior ground reaction force (F3,164 = 6.61, P = 0.004), peak hip power in preswing (F3,156 = 8.76, P < 0.001), and peak ankle power at push-off (F3,149 = 6.38, P = 0.005) all improved with respect to time. However, peak ankle ankle dorsiflexion in swing (F3,184 = 4.99, P = 0.031) worsened. In general, the greatest change for all parameters occurred during the treatment period. There were no significant treatment group × time interaction effects for any of the spatiotemporal, kinematic, or kinetic parameters. CONCLUSIONS: Gait training with peroneal nerve stimulation and usual care was associated with improvements in peak hip power in preswing and peak ankle power at push-off, which may have resulted in improved cadence, stride length, and walking speed; however, there were no differences between treatment groups. Both treatment groups also experienced a decrease in peak ankle ankle dorsiflexion in swing, although the clinical implications of this finding are unclear.

Effect of body mass index on hemiparetic gait.

OBJECTIVE: To evaluate the relationship between body mass index (BMI) and spatiotemporal, kinematic, and kinetic gait parameters in chronic hemiparetic stroke survivors. DESIGN: Secondary analysis of data collected in a randomized controlled trial comparing two 12-week ambulation training treatments. SETTING: Academic medical center. PARTICIPANTS: Chronic hemiparetic stroke survivors (N = 108, >3 months poststroke) METHODS: Linear regression analyses were performed of BMI, and selected pretreatment gait parameters were recorded using quantitative gait analysis. MAIN OUTCOME MEASURES: Spatiotemporal, kinematic, and kinetic gait parameters. RESULTS: A series of linear regression models that controlled for age, gender, stroke type (ischemic versus hemorrhagic), interval poststroke, level of motor impairment (Fugl-Meyer score), and walking speed found BMI to be positively associated with step width (m) (ß = 0.364, P < .001), positively associated with peak hip abduction angle of the nonparetic limb during stance (deg) (ß = 0.177, P = .040), negatively associated with ankle dorsiflexion angle at initial contact of the paretic limb (deg) (ß = -0.222, P = .023), and negatively associated with peak ankle power at push-off (W/kg) of the paretic limb (W/kg)(ß = -0.142, P = .026). CONCLUSIONS: When walking at a similar speed, chronic hemiparetic stroke subjects with a higher BMI demonstrated greater step width, greater hip hiking of the paretic lower limb, less paretic limb dorsiflexion at initial contact, and less paretic ankle power at push-off as compared to stroke subjects with a lower BMI and similar level of motor impairment. Further studies are necessary to determine the clinical relevance of these findings with respect to rehabilitation strategies for gait dysfunction in hemiparetic patients with higher BMIs.

Effects of intramuscular trunk stimulation on manual wheelchair propulsion mechanics in 6 subjects with spinal cord injury.

OBJECTIVE: To quantify the effects of stabilizing the paralyzed trunk and pelvis with electrical stimulation on manual wheelchair propulsion. DESIGN: Single-subject design case series with subjects acting as their own concurrent controls. SETTING: Hospital-based clinical biomechanics laboratory. PARTICIPANTS: Individuals (N=6; 4 men, 2 women; mean age ± SD, 46 ± 10.8y) who were long-time users (6.1 ± 3.9y) of implanted neuroprostheses for lower extremity function and had chronic (8.6 ± 2.8y) midcervical- or thoracic-level injuries (C6-T10). INTERVENTIONS: Continuous low-level stimulation to the hip (gluteus maximus, posterior adductor, or hamstrings) and trunk extensor (lumbar erector spinae and/or quadratus lumborum) muscles with implanted intramuscular electrodes. MAIN OUTCOME MEASURES: Pushrim kinetics (peak resultant force, fraction effective force), kinematics (cadence, stroke length, maximum forward lean), and peak shoulder moment at preferred speed over 10-m level surface; speed, pushrim kinetics, and subjective ratings of effort for level 100-m sprints and up a 30.5-m ramp of approximately 5% grade. RESULTS: Three of 5 subjects demonstrated reduced peak resultant pushrim forces (P≤.014) and improved efficiency (P≤.048) with stimulation during self-paced level propulsion. Peak sagittal shoulder moment remained unchanged in 3 subjects and increased in 2 others (P<.001). Maximal forward trunk lean also increased by 19% to 26% (P<.001) with stimulation in these 3 subjects. Stroke lengths were unchanged by stimulation in all subjects, and 2 showed extremely small (5%) but statistically significant increases in cadence (P≤.021). Performance measures for sprints and inclines were generally unchanged with stimulation; however, subjects consistently rated propulsion with stimulation to be easier for both surfaces. CONCLUSIONS: Stabilizing the pelvis and trunk with low levels of continuous electrical stimulation to the lumbar trunk and hip extensors can positively impact the mechanics of manual wheelchair propulsion and reduce both perceived and physical measures of effort.

Effects of stimulating hip and trunk muscles on seated stability, posture, and reach after spinal cord injury.

OBJECTIVE: To determine the stimulated strength of the paralyzed gluteal and paraspinal muscles and their effects on the seated function of individuals with paralysis. DESIGN: Case series with subjects acting as their own concurrent controls. SETTING: Hospital-based clinical biomechanics laboratory. PARTICIPANTS: Users (N=8) of implanted neuroprostheses for lower extremity function with low-cervical or thoracic level injuries. INTERVENTIONS: Dynamometry and digital motion capture both with and without stimulation to the hip and trunk muscles. MAIN OUTCOME MEASURES: Isometric trunk extension moment at 0°, 15°, and 30° of flexion; seated stability in terms of simulated isokinetic rowing; pelvic tilt, shoulder height, loaded and unloaded bimanual reaching to different heights, and subjective ratings of difficulty during unsupported sitting. RESULTS: Stimulation produced significant increases in mean trunk extension moment (9.2±9.5Nm, P<.001) and rowing force (27.4±23.1N, P<.012) over baseline volitional values. Similarly, stimulation induced positive changes in average pelvic tilt (16.7±15.7°) and shoulder height (2.2±2.5cm) during quiet sitting and bimanual reaching, and increased mean reach distance (5.5±6.6cm) over all subjects, target heights, and loading conditions. Subjects consistently rated tasks with stimulation easier than voluntary effort alone. CONCLUSIONS: In spite of considerable intersubject variability, stabilizing the paralyzed trunk with electrical stimulation can positively impact seated posture, extend forward reach, and allow exertion of larger forces on objects in the environment.

Spatiotemporal, kinematic, and kinetic effects of a peroneal nerve stimulator versus an ankle foot orthosis in hemiparetic gait.

BACKGROUND: The relative effect of a transcutaneous peroneal nerve stimulator (tPNS) and an ankle foot orthosis (AFO) on spatiotemporal, kinematic, and kinetic parameters of hemiparetic gait has not been well described. OBJECTIVE: To compare the relative neuroprosthetic effect of a tPNS with the orthotic effect of an AFO using quantitative gait analysis (QGA). DESIGN: In all, 12 stroke survivors underwent QGA under 3 device conditions: (1) no device (ND), (2) AFO, and (3) tPNS. A series of repeated-measures analyses of variance (rmANOVAs) were performed with dorsiflexion status (presence or absence of volitional dorsiflexion) as a covariate to compare selected spatiotemporal, kinematic, and kinetic parameters for each device condition. Post hoc pairwise comparisons and/or subset analysis by dorsiflexion status were performed for significant effect. RESULTS: Stride length was improved with both the AFO (P = .035) and the tPNS (P = .029) relative to ND. Those with absent dorsiflexion had longer stride length with the tPNS relative to ND (P = .034) and a higher walking velocity with a tPNS relative to the AFO (P = .015). There was no device effect on dorsiflexion angle at initial contact; however, a significant Device × Dorsiflexion status interaction effect favored the AFO relative to ND (P = .025) in those with dorsiflexion present. CONCLUSION: This study suggests that level of motor impairment may influence the relative effects of the tPNS and AFO devices in chronic hemiparetic gait; however, the small sample size limits generalizability. Future studies are necessary to determine if motor impairment level should be considered in the clinical prescription of these devices.

Longitudinal performance of a surgically implanted neuroprosthesis for lower-extremity exercise, standing, and transfers after spinal cord injury.

OBJECTIVE: To investigate the longitudinal performance of a surgically implanted neuroprosthesis for lower-extremity exercise, standing, and transfers after spinal cord injury. DESIGN: Case series. SETTING: Research or outpatient physical therapy departments of 4 academic hospitals. PARTICIPANTS: Subjects (N=15) with thoracic or low cervical level spinal cord injuries who had received the 8-channel neuroprosthesis for exercise and standing. INTERVENTION: After completing rehabilitation with the device, the subjects were discharged to unrestricted home use of the system. A series of assessments were performed before discharge and at a follow-up appointment approximately 1 year later. MAIN OUTCOME MEASURES: Neuroprosthesis usage, maximum standing time, body weight support, knee strength, knee fatigue index, electrode stability, and component survivability. RESULTS: Levels of maximum standing time, body weight support, knee strength, and knee fatigue index were not statistically different from discharge to follow-up (P>.05). Additionally, neuroprosthesis usage was consistent with subjects choosing to use the system on approximately half of the days during each monitoring period. Although the number of hours using the neuroprosthesis remained constant, subjects shifted their usage to more functional standing versus more maintenance exercise, suggesting that the subjects incorporated the neuroprosthesis into their lives. Safety and reliability of the system were demonstrated by electrode stability and a high component survivability rate (>90%). CONCLUSIONS: This group of 15 subjects is the largest cohort of implanted lower-extremity neuroprosthetic exercise and standing system users. The safety and efficiency data from this group, and acceptance of the neuroprosthesis as demonstrated by continued usage, indicate that future efforts toward commercialization of a similar device may be warranted.

Neurotherapeutic and neuroprosthetic effects of implanted functional electrical stimulation for ambulation after incomplete spinal cord injury.

The purpose of this single-subject study was to determine the neurotherapeutic and neuroprosthetic effects of an implanted functional electrical stimulation (FES) system designed to facilitate walking in an individual with a longstanding motor and sensory incomplete spinal cord injury. An implanted pulse generator and eight intramuscular stimulating electrodes were installed unilaterally, activating weak or paralyzed hip flexors, hip and knee extensors, and ankle dorsiflexors during 36 sessions of gait training with FES. The neurotherapeutic effects were assessed by a comparison of pre- and posttraining volitional walking. The neuroprosthetic effects were assessed by a comparison of posttraining volitional and FES-assisted walking. Treatment resulted in significant (p < 0.005) volitional improvements in 6-minute walking distance and speed, speed during maximum walk, double support time, and 10 m walking speed. Posttraining FES-assisted walking resulted in significant additional improvements in all these measures, except 10 m walking speed. When the subject was using FES-assisted gait, maximum walking distance, peak knee flexion in swing, peak ankle dorsiflexion in swing, and knee extension moment also significantly increased. Neuroprosthetic gains were sufficient to enable the subject to advance from household ambulation to limited community ambulation. Additionally, the subject could perform multiple walks per day when using FES-assisted gait, which was impossible with volitional effort alone.

Spatiotemporal and kinematic effect of peroneal nerve stimulation versus an ankle-foot orthosis in patients with multiple sclerosis: a case series.

OBJECTIVE: To compare the effect of a surface peroneal nerve stimulator (PNS) versus an ankle-foot orthosis (AFO) on spatiotemporal and kinematic parameters of gait in patients with multiple sclerosis. DESIGN: This was a case series design. PARTICIPANTS: Four subjects with multiple sclerosis and dorsiflexion weakness. INTERVENTION: Quantitative gait analysis with the use of (1) no device, (2) AFO, and (3) PNS as a single point-in-time assessment. OUTCOME MEASURES: Included walking speed, stride length, cadence, and double support time; kinematic parameters included peak pelvic obliquity during swing, peak contralateral hip abduction during stance, peak knee flexion and hip flexion during swing, ankle dorsiflexion at initial contact, and peak ankle internal rotation during swing. RESULTS: One-way analysis of variance was used to compare intrasubject performance under the 3 device conditions. The PNS significantly increased ankle dorsiflexion angle at initial contact, as compared with both no device and the AFO, in 3 of the 4 subjects. However, other spatiotemporal and kinematic gait parameters were more variably affected by the device conditions. CONCLUSIONS: With the exception of ankle dorsiflexion angle at initial contact, PNS and AFO have a variable effect on spatiotemporal and kinematic gait parameters in individual subjects with multiple sclerosis. Further studies are indicated to determine the clinical significance of intrasubject differences between device conditions.

Implanted electrical stimulation of the trunk for seated postural stability and function after cervical spinal cord injury: a single case study.

OBJECTIVES: To explore and quantify the physical and functional effects of stabilizing the torso with electrical stimulation of the paralyzed hip and trunk musculature after motor complete tetraplegia. DESIGN: Single-subject case study with repeated measures and concurrent controls. SETTING: Academic outpatient rehabilitation center. PARTICIPANTS: Forty-four-year-old man with C4 American Spinal Injury Association grade A tetraplegia 20 years postspinal cord injury. INTERVENTION: A surgically implanted multichannel pulse generator and intramuscular stimulating electrodes to activate lumbar erector spinae, quadratus lumborum, and gluteus maximus muscles bilaterally. MAIN OUTCOME MEASURES: Outcomes assessed with and without stimulation included (1) spinal alignment and pelvic orientation, (2) pulmonary function and ventilatory volumes, (3) forward bimanual reaching distance, (4) seated stability and resistance to externally applied disturbances, (5) maximal force and speed of rowing-like movements, and the ability to (6) independently return to an erect seated position from full forward or lateral flexion and (7) roll in bed without assistance. RESULTS: Stimulation improved spinal convexity and kyphosis by 26 degrees and 21 degrees , reduced posterior pelvic tilt by 11 degrees , increased forced expiratory volume and vital capacity by 10% and 22%, and improved forward reach by more than 7cm. Average resistance to sagittal disturbances increased by more than 40% (P<.002), and mean force exerted during underhanded pulling more than doubled (P=.014) with stimulation. Restoration of upright sitting in both sagittal and coronal planes and bed turning was made possible through appropriately timed activation of the hip and trunk muscles. CONCLUSIONS: A neuroprosthesis for controlling the paralyzed torso can positively impact spinal alignment, seated posture, pulmonary function, trunk stability, and reach. Stimulation of hip and trunk muscles can improve performance of activities of daily living as well as enable independent wheelchair and bed mobility.

Walking after incomplete spinal cord injury using an implanted FES system: a case report.

Implanted functional electrical stimulation (FES) systems for walking are experimentally available to individuals with incomplete spinal cord injury (SCI); however, data on short-term therapeutic and functional outcomes are limited. The goal of this study was to quantify therapeutic and functional effects of an implanted FES system for walking after incomplete cervical SCI. After robotic-assisted treadmill training and overground gait training maximized his voluntary function, an individual with incomplete SCI (American Spinal Injury Association grade C, cervical level 6-7) who could stand volitionally but not step was surgically implanted with an 8-channel receiver stimulator and intramuscular electrodes. Electrodes were implanted bilaterally, recruiting iliopsoas, vastus intermedius and lateralis, tensor fasciae latae, tibialis anterior, and peroneus longus muscles. Twelve weeks of training followed limited activity post-surgery. Customized stimulation patterns addressed gait deficits via an external control unit. The system was well-tolerated and reliable. After the 12-week training, maximal walking distance increased (from 14 m to 309 m), maximal walking speed was 10 times greater (from 0.02 m/s to 0.20 m/s), and physiological cost index was 5 times less (from 44.4 beats/m to 8.6 beats/m). Voluntary locomotor function was unchanged. The implanted FES system was well-tolerated, reliable, and supplemented function, allowing the participant limited community ambulation. Physiological effort decreased and maximal walking distance increased dramatically over 12 weeks.