Brief High-Velocity Motor Skill Training Increases Step Frequency and Improves Length/Frequency Coordination in Slow Walkers With Chronic Motor-Incomplete Spinal Cord Injury.

OBJECTIVE: To quantify spatiotemporal coordination during overground walking among persons with motor-incomplete spinal cord injury (PwMISCI) by calculating the step length (SL)/step frequency (SF) ratio (ie, the Walk Ratio [WR]) and to examine the effects of motor skill training (MST) on the relationship between changes in these parameters and walking speed (WS). DESIGN: Between-day exploratory analysis. SETTING: Research laboratory in a rehabilitation hospital PARTICIPANTS: PwMISCI (N=26). INTERVENTIONS: 3-day high-velocity MST. MAIN OUTCOME MEASURES: Overground WS, SL, SF, and WR measured during the 10-Meter Walk Test. RESULTS: Among the full sample, MST was associated with increases in WS, SL, SF, and a decrease in the WR. Relative change in WS and SF was higher among slow (ΔWS=↑46%, ΔSF=↑28%) vs fast (ΔWS=↑16%, ΔSF=↑8%) walkers. Change in the WR differed between groups (slow: ΔWR=↓10%; fast: ΔWR=0%). Twenty-six percent of the variability observed in ΔWR among slow walkers could be explained by ΔSF, while ΔSL did not contribute to ΔWR. Among fast walkers, ΔSL accounted for more than twice the observed ΔWR (43%) compared to ΔSF (15%). CONCLUSIONS: On the whole, WR values among PwMISCI are higher than previous reports in other neurologic populations; however, values among fast walkers were comparable to noninjured adults. Slow walkers demonstrated greater variability in the WR, with higher values associated with slower WS. Following MST, increases in WS coincided with a decrease in the WR among slow walkers, mediated primarily through an effect on SF. This finding may point to a specific mechanism by which MST facilitates improvements in WS among PwMISCI with greater mobility deficits.

Non-invasive Transcutaneous Spinal Cord Stimulation Programming Recommendations for the Treatment of Upper Extremity Impairment in Tetraplegia.

OBJECTIVES: This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS) to effectively improve upper extremity function after chronic spinal cord injury (SCI). It proposes a framework to guide stimulation programming decisions for the successful translation of these techniques into the clinic. MATERIALS AND METHODS: Programming data from 60 participants who completed the Up-LIFT trial and from 17 participants who subsequently completed the LIFT Home trial were analyzed. All observations of stimulation amplitudes, frequencies, waveforms, and electrode configurations were examined. The incidence of adverse events and relatedness to stimulation parameters is reported. A comparison of parameter usage across the American Spinal Injury Association Impairment Scale (AIS) subgroups was conducted to evaluate stimulation strategies across participants with varying degrees of sensorimotor preservation. RESULTS: Active (cathodal) electrodes were typically placed between the C3/C4 and C6/C7 spinous processes. Most sessions featured return (anodal) electrodes positioned bilaterally over the anterior superior iliac spine, although clavicular placement was frequently used by 12 participants. Stimulation was delivered with a 10-kHz carrier frequency and typically a 30-Hz burst frequency. Biphasic waveforms were used in 83% of sessions. Average stimulation amplitudes were higher for biphasic waveforms. The AIS B subgroup required significantly higher amplitudes than did the AIS C and D subgroups. Device-related adverse events were infrequent, and not correlated with specific waveforms or amplitudes. Within the home setting, participants maintained their current amplitudes within 1% of the preset values. The suggested stimulation programming framework dictates the following hierarchical order of parameter adjustments: current amplitude, waveform type, active/return electrode positioning, and burst frequency, guided by clinical observations as required. CONCLUSIONS: This analysis summarizes effective stimulation parameters from the trials and provides a decision-making framework for clinical implementation of tSCS for upper extremity functional restoration after SCI. The parameters are aligned with existing literature and proved safe and well tolerated by participants.

Cost-effectiveness analysis of overground robotic training versus conventional locomotor training in people with spinal cord injury.

BACKGROUND: Few, if any estimates of cost-effectiveness for locomotor training strategies following spinal cord injury (SCI) are available. The purpose of this study was to estimate the cost-effectiveness of locomotor training strategies following spinal cord injury (overground robotic locomotor training versus conventional locomotor training) by injury status (complete versus incomplete) using a practice-based cohort. METHODS: A probabilistic cost-effectiveness analysis was conducted using a prospective, practice-based cohort from four participating Spinal Cord Injury Model System sites. Conventional locomotor training strategies (conventional training) were compared to overground robotic locomotor training (overground robotic training). Conventional locomotor training included treadmill-based training with body weight support, overground training, and stationary robotic systems. The outcome measures included the calculation of quality adjusted life years (QALYs) using the EQ-5D and therapy costs. We estimate cost-effectiveness using the incremental cost utility ratio and present results on the cost-effectiveness plane and on cost-effectiveness acceptability curves. RESULTS: Participants in the prospective, practice-based cohort with complete EQ-5D data (n = 99) qualified for the analysis. Both conventional training and overground robotic training experienced an improvement in QALYs. Only people with incomplete SCI improved with conventional locomotor training, 0.045 (SD 0.28), and only people with complete SCI improved with overground robotic training, 0.097 (SD 0.20). Costs were lower for conventional training, $1758 (SD $1697) versus overground robotic training $3952 (SD $3989), and lower for those with incomplete versus complete injury. Conventional overground training was more effective and cost less than robotic therapy for people with incomplete SCI. Overground robotic training was more effective and cost more than conventional training for people with complete SCI. The incremental cost utility ratio for overground robotic training for people with complete spinal cord injury was $12,353/QALY. CONCLUSIONS: The most cost-effective locomotor training strategy for people with SCI differed based on injury completeness. Conventional training was more cost-effective than overground robotic training for people with incomplete SCI. Overground robotic training was more cost-effective than conventional training for people with complete SCI. The effect estimates may be subject to limitations associated with small sample sizes and practice-based evidence methodology. These estimates provide a baseline for future research.

A Pilot Study of Intensive Locomotor-Related Skill Training and Transcranial Direct Current Stimulation in Chronic Spinal Cord Injury.

BACKGROUND AND PURPOSE: Improved walking function is a priority among persons with motor-incomplete spinal cord injury (PwMISCI). Accessibility and cost limit long-term participation in locomotor training offered in specialized centers. Intensive motor training that facilitates neuroplastic mechanisms that support skill learning and can be implemented in the home/community may be advantageous for promoting long-term restoration of walking function. Additionally, increasing corticospinal drive via transcranial direct current stimulation (tDCS) may enhance training effects. In this pilot study, we investigated whether a moderate-intensity motor skill training (MST) circuit improved walking function in PwMISCI and whether augmenting training with tDCS influenced outcomes. METHODS: Twenty-five adults (chronic, motor-incomplete spinal cord injury) were randomized to a 3-day intervention of a locomotor-related MST circuit and concurrent application of sham tDCS (MST+tDCS sham ) or active tDCS (MST+tDCS). The primary outcome was overground walking speed. Secondary outcomes included walking distance, cadence, stride length, and step symmetry index (SI). RESULTS: Analyses revealed significant effects of the MST circuit on walking speed, walking distance, cadence, and bilateral stride length but no effect on interlimb SI. No significant between-groups differences were observed. Post hoc analyses revealed within-groups change in walking speed (ΔM = 0.13 m/s, SD = 0.13) that app-roached the minimally clinically important difference of 0.15 m/s. DISCUSSION AND CONCLUSIONS: Brief, intensive MST involving locomotor-related activities significantly increased walking speed, walking distance, and spatiotemporal measures in PwMISCI. Significant additive effects of tDCS were not observed; however, participation in only 3 days of MST was associated with changes in walking speed that were comparable to longer locomotor training studies.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A386 ).

Emergency Department Visits, Related Hospitalizations, and Reasons for Emergency Department Utilization After Traumatic Spinal Cord Injury.

OBJECTIVE: To identify the self-reported frequency of emergency department (ED) visits, ED-related hospitalizations, and reasons for ED visits among people with traumatic spinal cord injury (SCI) and compare them with general population data from the same geographic area. DESIGN: Cross-sectional. SETTING: A specialty hospital in the Southeastern United States. PARTICIPANTS: The participants (N=648) were community-dwelling adults (18 years and older) with a traumatic SCI, who were at least 1 year postinjury. A comparison group of 9728 individuals from the general population was retrieved from the 2017 National Health Interview Survey (NHIS). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Participants completed self-report assessments on ED visits, ED hospitalizations, and reasons for ED visits in the past 12 months using items from the NHIS. RESULTS: A total of 37% of participants with SCI reported at least 1 ED visit, and 18% reported at least 1 ED hospitalization in the past 12 months. Among those having at least 1 ED visit, 49% were admitted to hospitals. After controlling for sex, age, and race/ethnicity, participants with SCI were 151% more likely to visit the ED (odds ratio [OR], 2.51) and 249% more likely to have at least 1 ED hospitalization than the NHIS sample (OR, 3.49). Persons with SCI had a higher percentage of ED visits because of severe health conditions, reported an ED was the closest provider, and were more likely to arrive by ambulance. NHIS participants were more likely to visit the ED because no other option was available. CONCLUSIONS: Compared with those in the general population, individuals with SCI have substantially higher rates of ED visits, yet ED visits are not regularly assessed within the SCI Model Systems. ED visits may indicate the need for intervention beyond the acute condition leading directly to the ED visits and an opportunity to link individuals with resources needed to maintain function in the community.

Toward Improving the Prediction of Functional Ambulation After Spinal Cord Injury Through the Inclusion of Limb Accelerations During Sleep and Personal Factors.

OBJECTIVE: To determine if functional measures of ambulation can be accurately classified using clinical measures; demographics; personal, psychosocial, and environmental factors; and limb accelerations (LAs) obtained during sleep among individuals with chronic, motor incomplete spinal cord injury (SCI) in an effort to guide future, longitudinal predictions models. DESIGN: Cross-sectional, 1-5 days of data collection. SETTING: Community-based data collection. PARTICIPANTS: Adults with chronic (>1 year), motor incomplete SCI (N=27). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Ambulatory ability based on the 10-m walk test (10MWT) or 6-minute walk test (6MWT) categorized as nonambulatory, household ambulator (0.01-0.44 m/s, 1-204 m), or community ambulator (>0.44 m/s, >204 m). A random forest model classified ambulatory ability using input features including clinical measures of strength, sensation, and spasticity; demographics; personal, psychosocial, and environmental factors including pain, environmental factors, health, social support, self-efficacy, resilience, and sleep quality; and LAs measured during sleep. Machine learning methods were used explicitly to avoid overfitting and minimize the possibility of biased results. RESULTS: The combination of LA, clinical, and demographic features resulted in the highest classification accuracies for both functional ambulation outcomes (10MWT=70.4%, 6MWT=81.5%). Adding LAs, personal, psychosocial, and environmental factors, or both increased the accuracy of classification compared with the clinical/demographic features alone. Clinical measures of strength and sensation (especially knee flexion strength), LA measures of movement smoothness, and presence of pain and comorbidities were among the most important features selected for the models. CONCLUSIONS: The addition of LA and personal, psychosocial, and environmental features increased functional ambulation classification accuracy in a population with incomplete SCI for whom improved prognosis for mobility outcomes is needed. These findings provide support for future longitudinal studies that use LA; personal, psychosocial, and environmental factors; and advanced analyses to improve clinical prediction rules for functional mobility outcomes.

Predicting Duration of Outpatient Physical Therapy Episodes for Individuals with Spinal Cord Injury Based on Locomotor Training Strategy.

OBJECTIVE: To characterize individuals with spinal cord injuries (SCI) who use outpatient physical therapy or community wellness services for locomotor training and predict the duration of services, controlling for demographic, injury, quality of life, and service and financial characteristics. We explore how the duration of services is related to locomotor strategy. DESIGN: Observational study of participants at 4 SCI Model Systems centers with survival. Weibull regression model to predict the duration of services. SETTING: Rehabilitation and community wellness facilities at 4 SCI Model Systems centers. PARTICIPANTS: Eligibility criteria were SCI or dysfunction resulting in motor impairment and the use of physical therapy or community wellness programs for locomotor/gait training. We excluded those who did not complete training or who experienced a disruption in training greater than 45 days. Our sample included 62 participants in conventional therapy and 37 participants in robotic exoskeleton training. INTERVENTIONS: Outpatient physical therapy or community wellness services for locomotor/gait training. MAIN OUTCOME MEASURES: SCI characteristics (level and completeness of injury) and the duration of services from medical records. Self-reported perceptions of SCI consequences using the SCI-Functional Index for basic mobility and SCI-Quality of Life measurement system for bowel difficulties, bladder difficulties, and pain interference. RESULTS: After controlling for predictors, the duration of services for the conventional therapy group was an average of 63% longer than for the robotic exoskeleton group, however each visit was 50% shorter in total time. Men had an 11% longer duration of services than women had. Participants with complete injuries had a duration of services that was approximately 1.72 times longer than participants with incomplete injuries. Perceived improvement was larger in the conventional group. CONCLUSIONS: Locomotor/gait training strategies are distinctive for individuals with SCI using a robotic exoskeleton in a community wellness facility as episodes are shorter but individual sessions are longer. Participants' preferences and the ability to pay for ongoing services may be critical factors associated with the duration of outpatient services.

Characterizing the Experience of Spasticity after Spinal Cord Injury: A National Survey Project of the Spinal Cord Injury Model Systems Centers.

OBJECTIVE: To characterize the qualities that individuals with spinal cord injury (SCI) associate with their experience of spasticity and to describe the relationship between spasticity and perceived quality of life and the perceived value of spasticity management approaches. DESIGN: Online cross-sectional survey. SETTING: Multicenter collaboration among 6 Spinal Cord Injury Model Systems hospitals in the United States. PARTICIPANTS: Individuals with SCI (N=1076). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Qualities of Spasticity Questionnaire, modified Spinal Cord Injury-Spasticity Evaluation Tool (mSCI-SET), and the modified Patient-Reported Impact of Spasticity Measure (mPRISM). RESULTS: Respondents indicated that spasms most often occurred in response to movement-related triggering events. However, spontaneous spasms (ie, no triggering event) were also reported to be among the most common types. Frequency of spasms appears to decline with age. The highest frequency of spasms was reported by 56% of respondents aged <25 years and by only 28% of those >55 years. Stiffness associated with spasticity was reported to be more common than spasms (legs, 65% vs 54%; trunk, 33% vs 18%; arms, 26% vs 15%). Respondents reported negative effects of spasticity more commonly than positive effects. Based on their association with negative scores on the mSCI-SET and the mPRISM, the 5 most problematic experiences reported were stiffness all day, interference with sleep, painful spasms, perceived link between spasticity and pain, and intensification of pain before a spasm. Respondents indicated spasticity was improved more by stretching (48%) and exercise (45%) than by antispasmodics (38%). CONCLUSIONS: The experience of spasticity after SCI is complex and multidimensional, with consequences that affect mobility, sleep, comfort, and quality of life. Stiffness, rather than spasms, appears to be the most problematic characteristic of spasticity. Physical therapeutic interventions to treat spasticity warrant in-depth investigation.

Effects of whole-body vibration on neuropathic pain and the relationship between pain and spasticity in persons with spinal cord injury.

OBJECTIVE: Whole-body vibration (WBV) appears to modulate reflex hyperexcitability and spasticity. Due to common underlying neural mechanisms between spasticity and neuropathic pain, WBV may also reduce chronic pain after spinal cord injury (SCI). Our objective was to determine whether there are dose-related changes in pain following WBV and to examine the relationships between neuropathic pain and reflex excitability. STUDY DESIGN: Secondary analysis of a sub-population (participants with neuropathic pain, n = 16) from a larger trial comparing the effects of two different doses of WBV on spasticity in persons with SCI. SETTING: Hospital/Rehabilitation Center in Atlanta, GA, USA. METHODS: Participants were randomized to 8-bout or 16-bout WBV groups. Both groups received ten sessions of sham intervention, followed by ten sessions of WBV. Primary measures included the Neuropathic Pain Symptom Inventory (NPSI) for pain symptom severity and H-reflex paired-pulse depression (PPD) for reflex excitability. RESULTS: Mean change in NPSI scores were not significantly different between the groups (7 ± 6; p = 0.29; ES = 0.57); however, 8-bouts of WBV were consistently beneficial for participants with high neuropathic pain symptom severity (NPSI total score >30), while 16-bouts of WBV appeared to increase pain in some individuals with high NPSI scores. A baseline NPSI cut score of 30 predicted PPD response (sensitivity = 1.0, specificity = 0.83), with higher NPSI scores associated with decreased PPD in response to WBV. CONCLUSIONS: WBV in moderate doses appears to decrease neuropathic pain symptoms and improve reflex modulation. However, at higher doses neuropathic pain symptoms may be aggravated. Lower baseline NPSI scores were associated with improved reflex modulation.

Accuracy of self-reported severity and level of spinal cord injury.

STUDY DESIGN: Observational. OBJECTIVES: To assess accuracy of self-reported level of injury (LOI) and severity in individuals with chronic spinal cord injury (SCI) as compared with clinical examination. SETTING: An SCI Model System Hospital. METHODS: A 20-item survey evaluated demographics, physical abilities, and self-reported injury level and severity. A decision tree algorithm used responses to categorize participants into injury severity groups. Following the survey, participants underwent clinical examination to determine current injury level and severity. Participants were later asked three questions regarding S1 sparing. Chart abstraction was utilized to obtain initial injury level and severity. Injury level and severity from self-report, decision tree, clinical exam, and chart abstraction were compared. RESULTS: Twenty-eight individuals participated. Ninety-three percent correctly self-reported anatomical region of injury (ROI). Self-report of specific LOI matched current clinical LOI for 25% of participants, but matched initial LOI for 61%. Self-report of ASIA Impairment Scale (AIS) matched clinical AIS for 36%, but matched initial AIS for 46%. The injury severity decision tree was 75% accurate without, but 79% accurate with additional S1 questions. Self-report of deep anal pressure (DAP) was correct for 86% of participants, while self-report of voluntary anal contraction (VAC) was correct for 82%. CONCLUSION: Individuals with SCI are more accurate reporting ROI than specific LOI. Self-reported injury level and severity align more closely with initial clinical examination results than current exam results. Using aggregate data from multiple questions can categorize injury severity more reliably than self-report. Using this type of decision tree may improve injury severity classification in large survey studies.

Noninvasive neuromodulation and rehabilitation to promote functional restoration in persons with spinal cord injury.

PURPOSE OF REVIEW: This review will focus on the use of clinically accessible neuromodulatory approaches for functional restoration in persons with spinal cord injury (SCI). RECENT FINDINGS: Functional restoration is a primary rehabilitation priority for individuals with SCI. High-tech neuromodulatory modalities have been used in laboratory settings to improve hand and walking function as well as to reduce spasticity and pain in persons with SCI. However, the cost, limited accessibility, and required expertise are prohibitive for clinical applicability of these high-tech modalities. Recent literature indicates that noninvasive and clinically accessible approaches targeting supraspinal, spinal, and peripheral neural structures can modulate neural excitability. Although a limited number of studies have examined the use of these approaches for functional restoration and amelioration of secondary complications in SCI, early evidence investigating their efficacy when combined with training is encouraging. SUMMARY: Larger sample studies addressing both biomarker identification and dosing are crucial next steps in the field of neurorehabilitation research before novel noninvasive stimulation approaches can be incorporated into standard clinical practice.

Clinician Perceptions of Robotic Exoskeletons for Locomotor Training After Spinal Cord Injury: A Qualitative Approach.

OBJECTIVE: To describe the experiences of clinicians who have used robotic exoskeletons in their practice and acquire information that can guide clinical decisions and training strategies related to robotic exoskeletons. DESIGN: Qualitative, online survey study, and 4 single-session focus groups followed by thematic analysis to define themes. SETTING: Focus groups were conducted at 3 regional rehabilitation hospitals and 1 Veteran's Administration (VA) Medical Center. PARTICIPANTS: Clinicians (N=40) reported their demographic characteristics and clinical experience using robotic exoskeletons. Twenty-nine clinicians participated in focus groups at regional hospitals that use robotic exoskeletons, as well as 1 VA Medical Center. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Clinicians' preferences, experiences, training strategies, and clinical decisions on how robotic exoskeleton devices are used with Veterans and civilians with spinal cord injury. RESULTS: Clinicians had an average of 3 years of experience using exoskeletons in clinical and research settings. Major themes emerging from focus group discussions included appropriateness of patient goals, patient selection criteria, realistic patient expectations, patient and caregiver training for use of exoskeletons, perceived benefits, preferences regarding specific exoskeletons, and device limitations and therapy recommendations. CONCLUSIONS: Clinicians identified benefits of exoskeleton use including decreased physical burden and fatigue while maximizing patient mobility, increased safety of clinicians and patients, and expanded device awareness and preferences. Suitability of exoskeletons for patients with various characteristics and managing expectations were concerns. Clinicians identified research opportunities as technology continues to advance toward safer, lighter, and hands-free devices.

Modified PRISM and SCI-SET Spasticity Measures for Persons With Traumatic Spinal Cord Injury: Results of a Rasch Analyses.

OBJECTIVE: To evaluate the psychometric properties of the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) and Patient-Reported Impact of Spasticity Measure (PRISM) using Rasch analysis to optimize their validity and efficiency. DESIGN: Rasch analysis of the SCI-SET and PRISM represents a secondary analysis of data collected as part of a collaborative research project of the SCI Model Systems Centers. The overall survey was organized into 4 sections: (1) participant demographics and injury characteristics, (2) participant experiences of spasticity, (3) SCI-SET, and (4) PRISM. Participants were recruited from the community via multiple avenues. Data were collected and managed via an online survey tool using a secure web-based data management application. SETTING: Participating Spinal Cord Injury Model Systems Centers. PARTICIPANTS: Most participants (N=1239) had lived with their injury for more than 2 years and used a wheelchair as their primary mode of mobility. The majority of the sample (58%) sustained cervical injuries. INTERVENTIONS: None. MAIN OUTCOME MEASURES: SCI-SET and PRISM. RESULTS: The SCI-SET demonstrated strong measurement properties with acceptably high reliability and point-measure correlations and no evidence of multidimensionality. However, respondents underused some rating scale categories. Analyses of the PRISM demonstrated 3 distinct subscales relating to the physical, psychological, and social influences of spasticity; respondents underused some rating scale categories. Combining underused rating scale categories for both spasticity instruments resulted in increased reliability and reduced respondent burden compared with the original versions. Both the Modified SCI-SET (person separation reliability=0.93) and Modified PRISM (person separation reliability=0.85, 0.89, 0.83 for physical, psychological, and social subscores, respectively) display strong measurement properties. CONCLUSIONS: Measurement properties of the SCI-SET and PRISM improved from use of Rasch model methods. The SCI-SET required minor revisions, whereas the PRISM required definition of subscores. Both modified spasticity measures demonstrated adequate psychometric properties, and correlations among the modified measures were high, providing evidence of convergent validity. We recommend use of the Modified SCI-SET and Modified PRISM measures in future studies.

Users with spinal cord injury experience of robotic Locomotor exoskeletons: a qualitative study of the benefits, limitations, and recommendations.

BACKGROUND: Persons with spinal cord injury (SCI) may experience both psychological and physiological benefits from robotic locomotor exoskeleton use, and knowledgeable users may have valuable perspectives to inform future development. The objective of this study is to gain insight into the experiences, perspectives, concerns, and suggestions on the use of robotic locomotor exoskeletons by civilians and veterans living with SCI. METHODS: Participants reported their demographic characteristics and the extent of robotic exoskeleton use in an online survey. Then, 28 experienced robotic locomotor exoskeleton users participated in focus groups held at three regional hospitals that specialize in rehabilitation for persons with SCI. We used a qualitative description approach analysis to analyze the data, and included thematic analysis. RESULTS: Participants expressed that robotic exoskeletons were useful in therapy settings but, in their current form, were not practical for activities of daily living due to device limitations. Participants detailed the psychological benefits of being eye-level with their non-disabled peers and family members, and some reported physiologic improvements in areas such as bowel and bladder function. Participants detailed barriers of increased fatigue, spasticity, and spasms and expressed dissatisfaction with the devices due to an inability to use them independently and safely. Participants provided suggestions to manufacturers for technology improvements. CONCLUSIONS: The varied opinions and insights of robotic locomotor exoskeletons users with SCI add to our knowledge of device benefits and limitations.

Budget impact analysis of robotic exoskeleton use for locomotor training following spinal cord injury in four SCI Model Systems.

BACKGROUND: We know little about the budget impact of integrating robotic exoskeleton over-ground training into therapy services for locomotor training. The purpose of this study was to estimate the budget impact of adding robotic exoskeleton over-ground training to existing locomotor training strategies in the rehabilitation of people with spinal cord injury. METHODS: A Budget Impact Analysis (BIA) was conducted using data provided by four Spinal Cord Injury (SCI) Model Systems rehabilitation hospitals. Hospitals provided estimates of therapy utilization and costs about people with spinal cord injury who participated in locomotor training in the calendar year 2017. Interventions were standard of care walking training including body-weight supported treadmill training, overground training, stationary robotic systems (i.e., treadmill-based robotic gait orthoses), and overground robotic exoskeleton training. The main outcome measures included device costs, training costs for personnel to use the device, human capital costs of locomotor training, device demand, and the number of training sessions per person with SCI. RESULTS: Robotic exoskeletons for over-ground training decreased hospital costs associated with delivering locomotor training in the base case analysis. This analysis assumed no difference in intervention effectiveness across locomotor training strategies. Providing robotic exoskeleton overground training for 10% of locomotor training sessions over the course of the year (range 226-397 sessions) results in decreased annual locomotor training costs (i.e., net savings) between $1114 to $4784 per annum. The base case shows small savings that are sensitive to parameters of the BIA model which were tested in one-way sensitivity analyses, scenarios analyses, and probability sensitivity analyses. The base case scenario was more sensitive to clinical utilization parameters (e.g., how often devices sit idle and the substitution of high cost training) than device-specific parameters (e.g., robotic exoskeleton device cost or device life). Probabilistic sensitivity analysis simultaneously considered human capital cost, device cost, and locomotor device substitution. With probabilistic sensitivity analysis, the introduction of a robotic exoskeleton only remained cost saving for one facility. CONCLUSIONS: Providing robotic exoskeleton for over-ground training was associated with lower costs for the locomotor training of people with SCI in the base case analyses. The analysis was sensitive to parameter assumptions.

Experience of Robotic Exoskeleton Use at Four Spinal Cord Injury Model Systems Centers.

BACKGROUND AND PURPOSE: Refinement of robotic exoskeletons for overground walking is progressing rapidly. We describe clinicians' experiences, evaluations, and training strategies using robotic exoskeletons in spinal cord injury rehabilitation and wellness settings and describe clinicians' perceptions of exoskeleton benefits and risks and developments that would enhance utility. METHODS: We convened focus groups at 4 spinal cord injury model system centers. A court reporter took verbatim notes and provided a transcript. Research staff used a thematic coding approach to summarize discussions. RESULTS: Thirty clinicians participated in focus groups. They reported using exoskeletons primarily in outpatient and wellness settings; 1 center used exoskeletons during inpatient rehabilitation. A typical episode of outpatient exoskeleton therapy comprises 20 to 30 sessions and at least 2 staff members are involved in each session. Treatment focuses on standing, stepping, and gait training; therapists measure progress with standardized assessments. Beyond improved gait, participants attributed physiological, psychological, and social benefits to exoskeleton use. Potential risks included falls, skin irritation, and disappointed expectations. Participants identified enhancements that would be of value including greater durability and adjustability, lighter weight, 1-hand controls, ability to navigate stairs and uneven surfaces, and ability to balance without upper extremity support. DISCUSSION AND CONCLUSIONS: Each spinal cord injury model system center had shared and distinct practices in terms of how it integrates robotic exoskeletons into physical therapy services. There is currently little evidence to guide integration of exoskeletons into rehabilitation therapy services and a pressing need to generate evidence to guide practice and to inform patients' expectations as more devices enter the market.Video Abstract available for more insights from the authors (see Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A231).

Medical Rehabilitation: Guidelines to Advance the Field With High-Impact Clinical Trials.

The purpose of this Special Communication is to summarize guidelines and recommendations stemming from an expert panel convened by the National Institutes of Health, National Center for Medical Rehabilitation Research (NCMRR) for a workshop entitled The Future of Medical Rehabilitation Clinical Trials, held September 29-30, 2016, at the NCMRR offices in Bethesda, Maryland. The ultimate goal of both the workshop and this summary is to offer guidance on clinical trials design and operations to the medical rehabilitation research community, with the intent of maximizing the effect of future trials.

The experience of spasticity after spinal cord injury: perceived characteristics and impact on daily life.

STUDY DESIGN: Cross-sectional survey. OBJECTIVES: Determine the impact of motor control characteristics attributed to spasticity, such as spasms, stiffness, and clonus on the daily life of people with spinal cord injury (SCI). SETTING: Nationwide, United States. METHODS: Internet-administered questionnaire, the Patient Reported Impact of Spasticity Measure (PRISM) and items describing characteristics of spasticity including stiffness, spasms, clonus, and pain. RESULTS: Of the 145 respondents, 113 (78%) reported a PRISM score of at least 5/164, indicating spasticity had some impact on their daily lives. Stiffness impact was highly correlated (ρ = 0.84; p < 0.01) with the PRISM negative impact on Daily Activities subscale and moderately correlated with the other PRISM subscales (ρ = 0.55-0.63; p < 0.01). Spasm presence had a negligible or low correlation with PRISM negative impact subscales (ρ = 0.29-0.47; p < 0.01). Trunk muscle stiffness and spasms had a low correlation with PRISM Need for Assistance and Daily activities (ρ = 0.42 and ρ = 0.41, p < 0.01, respectively). Anti-spasticity medications were ineffective for 58% of respondents. Pain in the legs was reported by 57% of respondents. CONCLUSIONS: The experience of spasticity is highly individualized, and is often distributed differently across arms, trunk, and legs. Despite the fact that traditional definitions of spasticity focus on reflex responsiveness, the stiffness associated with spasticity appears to be more problematic than spasms or clonus. The self-described characteristics of spasticity and its physiological presentation are complex and related to pain. This varied presentation lends support to the concept that management of spasticity may be best achieved by multimodality strategies.

Lymphedema techniques to manage edema after SCI: a retrospective analysis.

STUDY DESIGN: Retrospective analysis of treatment data for a cohort of clients with spinal cord injury (SCI) who received therapy for management of edema. OBJECTIVE: To evaluate the safety, feasibility, and benefit of a modified lymphedema treatment approach for treatment of chronic lower extremity edema in persons with SCI. SETTING: A specialty rehabilitation hospital in Atlanta, GA, USA. METHODS: Certified lymphedema therapists with experience in SCI rehabilitation modified standard complete decongestive therapy (CDT) techniques to accommodate sensory and motor impairments and ensure skin safety. Therapists applied the modified CDT (mCDT) approach as part of treatment in 59 adults with SCI and lower extremity edema. Limb volume was measured using standardized volumetric measurement, pitting was scored using a standardized scale (range 0-4), and edema characteristics were determined to be present or absent. Outcomes of the mCDT intervention were analyzed for 105 lower extremities. RESULTS: Outcomes indicated that mCDT was associated with significant reduction in limb volumes, with a mean decrease of 11 ± 7.6%. Significant decreases were also observed in pitting edema and edema-specific characteristics, mean pitting scale score was reduced from a 3/4 to a 1/4. Minor adverse events were identified in a small number of patients. CONCLUSIONS: We found the mCDT approach to be safe and well-tolerated by the patients with SCI. The intervention was associated with decreased edema, and was feasible for use in a clinical setting. We recommend considering this mCDT approach for management of edema in individuals with SCI, while remaining vigilant about skin inspection.

Author Correction: The experience of spasticity after spinal cord injury: perceived characteristics and impact on daily life.

There is an author correction associated with this article.