Crash Risk Following Return to Driving After Moderate-to-Severe TBI: A TBI Model Systems Study.

OBJECTIVE: To examine motor vehicle crash frequency and risk factors following moderate-to-severe traumatic brain injury (TBI). SETTING: Eight TBI Model Systems sites. Participants: Adults ( N = 438) with TBI who required inpatient acute rehabilitation. DESIGN: Cross-sectional, observational design. MAIN MEASURES: Driving survey completed at phone follow-up 1 to 30 years after injury. RESULTS: TBI participants reported 1.5 to 2.5 times the frequency of crashes noted in the general population depending on the time frame queried, even when accounting for unreported crashes. Most reported having no crashes; for those who experienced a crash, half of them reported a single incident. Based on logistic regression, age at survey, years since injury, and perception of driving skills were significantly associated with crashes. CONCLUSION: Compared with national statistics, crash risk is higher following TBI based on self-report. Older age and less time since resuming driving were associated with lower crash risk. When driving was resumed was not associated with crash risk. These results do not justify restricting people from driving after TBI, given that the most who resumed driving did not report experiencing any crashes. However, there is a need to identify and address factors that increase crash risk after TBI.

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.

Utilization of Robotic Exoskeleton for Overground Walking in Acute and Chronic Stroke.

Stroke commonly results in gait deficits which impacts functional ambulation and quality of life. Robotic exoskeletons (RE) for overground walking are devices that are programmable to provide high dose and movement-impairment specific assistance thus offering new rehabilitation possibilities for recovery progression in individuals post stroke. The purpose of this investigation is to present preliminary utilization data in individuals with acute and chronic stroke after walking overground with an RE. Secondary analysis on a subset of individuals is presented to understand the mechanistic changes due to RE overground walking. Thirty-eight participants with hemiplegia secondary to stroke were enrolled in a clinical trial conducted at eight rehabilitation centers. Data is presented for four sessions of overground walking in the RE over the course of 2 weeks. Participants continued their standard of care if they had any ongoing therapy at the time of study enrollment. Gait speed during the 10 Meter Walk Test, Gait deviations and the Functional Ambulation Category (FAC) data were collected before (baseline) and after (follow-up) the RE walking sessions. Walking speed significantly increased between baseline and follow-up for participants in the chronic (p <0.01) and acute (p < 0.05) stage of stroke recovery. FAC level significantly improved (p < 0.05) and there were significantly fewer (p < 0.05) gait deviations observed for participants in the acute stages of stroke recovery between baseline and follow-up. Secondary analysis on a subset of eight participants indicated that after four sessions of overground walking with the RE, the participants significantly improved their spatial symmetry. The walk time, step count and ratio of walk time to up time increased from first session to the last session for participants in the chronic and acute stages of stroke. The RE was effectively utilized for overground walking for individuals with acute and chronic stroke with varying severity levels. The results demonstrated an increase in walking speed, improvement in FAC and a decrease in gait deviations (from baseline to follow-up) after four sessions of overground walking in the RE for participants. In addition, preliminary data indicated that spatial symmetry and step length also improved after utilization of an RE for overground walking.

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.

Associations Between Insurance Provider and Assistive Technology Use for Computer and Electronic Devices 1 Year After Tetraplegia: Findings From the Spinal Cord Injury Model Systems National Database.

OBJECTIVE: To investigate the association between insurance provider and reported assistive technology (AT) use to access computers and electronic devices 1 year after sustaining tetraplegia. DESIGN: Multicenter cross-sectional study. SETTING: Participants enrolled in the Spinal Cord Injury Model Systems (SCIMS) National Database. INTERVENTIONS: Not applicable. PARTICIPANTS: Men and women with tetraplegia (N=498) enrolled in the SCIMS National Database were included in the analysis. MAIN OUTCOME MEASURES: The primary study outcome was the use of AT when operating a computer or other mobile electronic device. The primary predictor was the subject's principal health insurance provider, which was grouped into the 3 categories: government (Medicare, Medicaid, and other government), private (private insurance, private funds, and other), and workers' compensation. RESULTS: Overall, 34.7% of participants reported using AT to access computers and electronic devices. Results of logistic regression analysis revealed sex, injury level, injury completeness, self-perceived health status, and 12-month history of pressure ulcer were all significantly associated with AT use. After adjusting for these factors, participants with workers' compensation were more likely to report AT use than individuals with either government or private insurance. CONCLUSIONS: Despite significant technological advances, AT is not readily available to the people who might benefit most from its use. Findings from the present study are the first to shed light on AT funding sources and reveal that individuals with workers' compensation are more likely use AT than individuals with either government or private insurance. Additional work focused on AT use and functional outcomes is needed to assess the effect of barriers to use. Collectively, this work may inform insurers of the importance of having AT available for this unique population to potentially improve quality of life and participation.

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).

Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury.

Objective: To assess safety and mobility outcomes utilizing the Indego powered exoskeleton in indoor and outdoor walking conditions with individuals previously diagnosed with a spinal cord injury (SCI). Methods: We conducted a multicenter prospective observational cohort study in outpatient clinics associated with 5 rehabilitation hospitals. A convenience sample of nonambulatory individuals with SCI (N = 32) completed an 8-week training protocol consisting of walking training 3 times per week utilizing the Indego powered exoskeleton in indoor and outdoor conditions. Participants were also trained in donning/doffing the exoskeleton during each session. Safety measures such as adverse events (AEs) were monitored and reported. Time and independence with donning/doffing the exoskeleton as well as walking outcomes to include the 10-meter walk test (10MWT), 6-minute walk test (6MWT), Timed Up & Go test (TUG), and 600-meter walk test were evaluated from midpoint to final evaluations. Results: All 32 participants completed the training protocol with limited device-related AEs, which resulted in no interruption in training. The majority of participants in this trial were able to don and doff the Indego independently. Final walking speed ranged from 0.19 to 0.55 m/s. Final average indoor and outdoor walking speeds among all participants were 0.37 m/s (SD = 0.08, 0.09, respectively), after 8 weeks of training. Significant (p < .05) improvements were noted between midpoint and final gait speeds in both indoor and outdoor conditions. Average walking endurance also improved among participants after training. Conclusion: The Indego was shown to be safe for providing upright mobility to 32 individuals with SCIs who were nonambulatory. Improvements in speed and independence were noted with walking in indoor and outdoor conditions as well as with donning/doffing the exoskeleton.

Step Ergometer Training Augmented With Functional Electrical Stimulation in Individuals With Chronic Spinal Cord Injury: A Feasibility Study.

Spinal cord injury (SCI) often results in loss of upright mobility and independence subsequently challenging rehabilitation practitioners for meaningful intervention strategies. The objective of this study was to evaluate the feasibility and potential impact on walking function of the stimulation and ergometer training protocol (STEP) in chronic SCI. Fourteen individuals with a chronic motor incomplete SCI (>1-year post injury) were enrolled in the study. The intervention consisted of a 12-week walking training program delivered three times per week from 20 up to 45 min in combination with 10 channels of FES on a step ergometer. Subsequent to this training, 30 min over ground walking training was performed. Ten out of the 14 participants completed the trial (71%). All participants who completed the intervention increased their walking speed by an average of 0.13 m/s (0.08) and walking endurance by an average of 117 ft (84 ft). For those who completed the trial, 50% demonstrated increases on the Walking Index for Spinal Cord Injury II by at least one level while 60% demonstrated an increase in lower extremity motor scores; all completing the Timed Up and Go Test at baseline demonstrated a reduction in time to complete during post-test evaluation. Recruitment objectives were attained. Overall retention was lower than anticipated with 29% withdrawing secondary to issues with lower extremity pain and exertional demands; however, no other adverse events occurred. Improvements in mobility outcomes generated by the STEP show promise in the context of feasibility and warrant further investigation to evaluate efficacy in comparison to other walking recovery interventions. The STEP was well-tolerated by participants who were >1 year and less than 10 years post SCI. Those completing the protocol exhibited improvements in commonly used SCI walking outcome measures.

Activity-based Therapies in Spinal Cord Injury:: Clinical Focus and Empirical Evidence in Three Independent Programs.

This article summarizes presentations of a symposium examining the potential impact of activity-based therapies (ABT) in promoting neurological and functional recovery after spinal cord injury (SCI). The symposium addressed 3 key questions concerning activity-based therapy in SCI: (1) What clinical approaches are used? (2) Is there empirical evidence supporting efficacy of ABT in promoting neurological recovery and improving overall function, health, and quality of life? (3) What are the issues related to long-term viability of ABT?