Interpreting Change in Disorders of Consciousness Using the Coma Recovery Scale-Revised.

The purpose of this study was to differentiate clinically meaningful improvement or deterioration from normal fluctuations in patients with disorders of consciousness (DoC) following severe brain injury. We computed indices of responsiveness for the Coma Recovery Scale-Revised (CRS-R) using data from a clinical trial of 180 participants with DoC. We used CRS-R scores from baseline (enrollment in a clinical trial) and a 4-week follow-up assessment period for these calculations. To improve precision, we transformed ordinal CRS-R total scores (0-23 points) to equal-interval measures on a 0-100 unit scale using Rasch Measurement theory. Using the 0-100 unit total Rasch measures, we calculated distribution-based 0.5 standard deviation (SD) minimal clinically important difference, minimal detectable change using 95% confidence intervals, and conditional minimal detectable change using 95% confidence intervals. The distribution-based minimal clinically important difference evaluates group-level changes, whereas the minimal detectable change values evaluate individual-level changes. The minimal clinically important difference and minimal detectable change are derived using the overall variability across total measures at baseline and 4 weeks. The conditional minimal detectable change is generated for each possible pair of CRS-R Rasch person measures and accounts for variation in standard error across the scale. We applied these indices to determine the proportions of participants who made a change beyond measurement error within each of the two subgroups, based on treatment arm (amantadine hydrochloride or placebo) or categorization of baseline Rasch person measure to states of consciousness (i.e., unresponsive wakefulness syndrome and minimally conscious state). We compared the proportion of participants in each treatment arm who made a change according to the minimal detectable change and determined whether they also changed to another state of consciousness. CRS-R indices of responsiveness (using the 0-100 transformed scale) were as follows: 0.5SD minimal clinically important difference = 9 units, minimal detectable change = 11 units, and the conditional minimal detectable change ranged from 11 to 42 units. For the amantadine and placebo groups, 70% and 58% of participants showed change beyond measurement error using the minimal detectable change, respectively. For the unresponsive wakefulness syndrome and minimally conscious state groups, 54% and 69% of participants changed beyond measurement error using the minimal detectable change, respectively. Among 115 participants (64% of the total sample) who made a change beyond measurement error, 29 participants (25%) did not change state of consciousness. CRS-R indices of responsiveness can support clinicians and researchers in discerning when behavioral changes in patients with DoC exceed measurement error. Notably, the minimal detectable change can support the detection of patients who make a "true" change within or across states of consciousness. Our findings highlight that the continued use of ordinal scores may result in incorrect inferences about the degree and relevance of a change score.

Randomized Trial of Two Exercise Programs to Increase Physical Activity and Health-Related Quality of Life for Persons With Spinal Cord Injury.

Objectives: To compare the effectiveness of two different interventions that promote physical activity in individuals with traumatic spinal cord injury (SCI) and determine the effect of relapse prevention. Methods: A sequential, multiple assignment, randomized trial was conducted at a universally designed community-based exercise facility. Participants were individuals with traumatic SCI, >3 months post injury, levels C5 to T12, age ≥18 years (N = 79). After randomization, Bridge Program participants completed an 8-week personalized, less intense, exercise program informed by American College of Sports Medicine (ACSM) guidelines and supported with hands-on peer mentoring, exercise of choice, and caregiver training. Structured Exercise participants completed an 8-week program in a group format based on ACSM guidelines. After intervention, participants were randomized to receive or not receive relapse prevention for 6 months. The time and intensity of physical activity and psychological change in depression, anxiety, self-efficacy, and function were assessed with self-reported measures. Results: Compared to baseline, physical activity increased post intervention for both the Bridge and Structured Exercise programs. Compared to baseline, participants in the Bridge Program recorded fewer anxiety symptoms. No significant changes were noted for either program in depressive symptoms, self-efficacy, or function. There was no difference in relapse prevention between the two groups at 6 months. Conclusions: The Bridge Program, a novel personalized exercise program with peer support, exercise of choice, and caregiver training, and a structured exercise program both improved self-reported physical activity, but the Bridge Program also reduced anxiety symptoms. This study provides important insight into the limitations of commonly used measures of physical activity and psychosocial domains in people with SCI.

Exploratory examination of the scale structure of the Moorong Self-Efficacy Scale: Application of Rasch Measurement Theory.

OBJECTIVE: Exploratory application of the Rasch Measurement (RM) Model for evidence for reproducibility, conceptual/content validity, and structural validity of the Moorong Self-Efficacy Scale (MSES). STUDY DESIGN: Secondary RM analysis of data collected in a randomized controlled trial comparing two exercise interventions for persons living with spinal cord injury (SCI). SETTING: Community-dwelling persons living with SCI enrolled in an exercise study. PARTICIPANTS: Adults (n = 79) enrolled in the parent study had a traumatic SCI > 3 months prior, injury level C5 to T12. INTERVENTIONS: Not applicable. OUTCOME MEASURE: The original MSES is a 16-item measure of self-efficacy with a 7-level response scale for un/certainty which was developed for use with persons living with SCI. RESULTS: We addressed item misfit, infrequent category endorsement, and category step disorder by removing two items and reorganizing the rating scale. Rating scale changes removed category 4 (Neutral), combined categories 1-3 (Very Uncertain, Somewhat Uncertain, and Uncertain) for all items, and further combined certainty categories for two items. Principal components analysis of the residuals indicated a possible second dimension with a first-contrast Eigenvalue of 2.4. However, the contrasted item groups had explained variance <10% and a dis-attenuated correlation = 0.92 indicating they measure the same underlying trait. The small sample size precluded examination of differential item functioning. CONCLUSIONS: Exploratory RM analysis of MSES produced a 14-item Rasch version which identified structural and content validity evidence concerns inherent in the original MSES. However, results could be biased by a small sample size and further study should examine the item content and rating scale structure with larger, more diverse samples of persons living with SCI.

Comparing indices of responsiveness for the Coma Near-Coma Scale with and without pain items: An Exploratory study.

INTRODUCTION: This study aimed to establish the indices of responsiveness for the Coma/Near-Coma (CNC) scale without (8 items) and with (10 items) pain test stimuli. A secondary purpose was to examine whether the CNC 8 items and 10 items differ when detecting change in neurobehavioral function. METHODS: We analyzed CNC data from three studies of participants with disorders of consciousness: one observational study and two intervention studies. We generated Rasch person measures using the CNC 8 items and CNC 10 items for each participant at two time points 14 ± 2 days apart using Rasch Measurement Theory. We calculated the distribution-based minimal clinically important difference (MCID) and minimal detectable change using 95% confidence intervals (MDC95 ). RESULTS: We used the Rasch transformed equal-interval scale person measures in logits. For the CNC 8 items: Distribution-based MCID 0.33 SD = 0.41 logits and MDC95  = 1.25 logits. For the CNC 10 items: Distribution-based MCID 0.33 SD = 0.37 logits and MDC95  = 1.03 logits. Twelve and 13 participants made a change beyond measurement error (MDC95 ) using the CNC 8-item and 10-item scales, respectively. CONCLUSION: Our preliminary evidence supports the clinical and research utility of the CNC 8-item scale for measuring the responsiveness of neurobehavioral function, and that it demonstrates comparable responsiveness to the CNC 10-item scale without administering the two pain items. The distribution-based MCID can be used to evaluate group-level changes while the MDC95 can support clinical, data-driven decisions about an individual patient.

Prognosis of Individual-Level Mobility and Daily Activities Recovery From Acute Care to Community, Part 2: A Proof-of-Concept Single Group Prospective Cohort Study.

OBJECTIVE: To demonstrate a proof-of-concept for prognostic models of post-stroke recovery on activity level outcomes. DESIGN: Longitudinal cohort with repeated measures from acute care, inpatient rehabilitation, and post-discharge follow-up to 6 months post-stroke. SETTING: Enrollment from a single Midwest USA inpatient rehabilitation facility with community follow-up. PARTICIPANTS: One-hundred fifteen persons recovering from stroke admitted to an acute rehabilitation facility (N=115). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE(S): Activity Measure for Post-Acute Care Basic Mobility and Daily Activities domains administered as 6 Clicks and patient-reported short forms. RESULTS: The final Basic Mobility model defined a group-averaged trajectory rising from a baseline (pseudo-intercept) T score of 35.5 (P<.001) to a plateau (asymptote) T score of 56.4 points (P<.001) at a negative exponential rate of -1.49 (P<.001). Individual baseline scores varied by age, acute care tissue plasminogen activator, and acute care length of stay. Individual plateau scores varied by walking speed, acute care tissue plasminogen activator, and lower extremity Motricity Index scores. The final Daily Activities model defined a group-averaged trajectory rising from a baseline T score of 24.5 (P<.001) to a plateau T score of 41.3 points (P<.001) at a negative exponential rate of -1.75 (P<.001). Individual baseline scores varied by acute care length of stay, and plateau scores varied by self-care, upper extremity Motricity Index, and Berg Balance Scale scores. CONCLUSIONS: As a proof-of-concept, individual activity-level recovery can be predicted as patient-level trajectories generated from electronic medical record data, but models require attention to completeness and accuracy of data elements collected on a fully representative patient sample.

Prognosis of Individual-Level Mobility and Self-Care Stroke Recovery During Inpatient Rehabilitation, Part 1: A Proof-of-Concept Single Group Retrospective Cohort Study.

OBJECTIVE: To demonstrate feasibility of generating predictive short-term individual trajectory recovery models after acute stroke by extracting clinical data from an electronic medical record (EMR) system. DESIGN: Single-group retrospective patient cohort design. SETTING: Stroke rehabilitation unit at an independent inpatient rehabilitation facility (IRF). PARTICIPANTS: Cohort of 1408 inpatients with acute ischemic or hemorrhagic stroke with a mean ± SD age of 66 (14.5) years admitted between April 2014 and October 2019 (N=1408). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: 0-100 Rasch-scaled Functional Independence Measure (FIM) Mobility and Self-Care subscales. RESULTS: Unconditional models were best-fit on FIM Mobility and Self-Care subscales by spline fixed-effect functions with knots at weeks 1 and 2, and random effects on the baseline (FIM 0-100 Rasch score at IRF admission), initial rate (slope at time zero), and second knot (change in slope pre-to-post week 2) parameters. The final Mobility multivariable model had intercept associations with Private/Other Insurance, Ischemic Stroke, Serum Albumin, Motricity Index Lower Extremity, and FIM Cognition; and initial slope associations with Ischemic Stroke, Private/Other and Medicaid Insurance, and FIM Cognition. The final Self-Care multivariable model had intercept associations with Private/Other Insurance, Ischemic Stroke, Living with One or More persons, Serum Albumin, and FIM Cognition; and initial slope associations with Ischemic Stroke, Private/Other and Medicaid Insurance, and FIM Cognition. Final models explained 52% and 27% of the variance compared with unconditional Mobility and Self-Care models. However, some EMR data elements had apparent coding errors or missing data, and desired elements from acute care were not available. Also, unbalanced outcome data may have biased trajectories. CONCLUSIONS: We demonstrate the feasibility of developing individual-level prognostic models from EMR data; however, some data elements were poorly defined, subject to error, or missing for some or all cases. Development of prognostic models from EMR will require improvements in EMR data collection and standardization.

Reporting Guideline for RULER: Rasch Reporting Guideline for Rehabilitation Research: Explanation and Elaboration.

The Rasch Reporting Guideline for Rehabilitation Research (RULER) provides peer-reviewed, evidence-based, transparent, and consistent recommendations for reporting studies that apply Rasch Measurement (RM) Theory in a rehabilitation context. The purpose of the guideline is to ensure that authors, reviewers, and editors have uniform guidance about how to write and evaluate research on rehabilitation outcome assessments. The RULER statement includes an organizing framework and a checklist of 59 recommendations. This companion article supports the RULER statement by providing details about the framework, rationale for the domains and recommendations in the checklist and explaining why these considerations are important for improving consistency and transparency in reporting the results of RM studies. This article is not intended to describe how to conduct RM studies but provides rationale for the essential elements that authors should address in each domain. Consistency and transparency in reporting RM studies will advance rehabilitation research if authors consider these issues when planning their study and include the checklist when they submit their manuscript for peer review. A copy of the checklist can be found at [table 2 in https://doi.org/10.1016/j.apmr.2022.03.013].

Rasch Reporting Guideline for Rehabilitation Research (RULER): the RULER Statement.

The application of Rasch Measurement (RM) Theory to rehabilitation assessments has proliferated in recent years. RM Theory helps design and refine assessments so that items reflect a unidimensional construct in an equal interval metric that distinguishes among persons of different abilities in a manner that is consistent with the underlying trait. Rapid growth of RM in rehabilitation assessment studies has led to inconsistent results reporting. Clear, consistent, transparent reporting of RM Theory results is important for advancing rehabilitation science and practice based on precise measures. Precise measures, in turn, provide researchers, practitioners, patients, and other stakeholders with tools for effective decision making. The goal of this Rasch Reporting Guideline for Rehabilitation Research (RULER: Rasch Reporting Guideline for Rehabilitation Research) is to provide peer-reviewed, evidence-based, transparent, and consistent recommendations for reporting studies that apply RM Theory in a rehabilitation context. The purpose of the guideline is to ensure that authors, reviewers, and editors have uniform expectations about how to write and evaluate research on rehabilitation outcome assessments. A task force of rehabilitation researchers, clinicians, and editors met regularly between November 2018 and August 2020 to identify the need for the guideline, develop an organizing framework, identify content areas, and develop the recommendations. This RULER: Rasch Reporting Guideline for Rehabilitation Research statement includes the organizing framework and a checklist of 59 recommendations. The guideline is supported by an Explanation and Elaboration article that provides more detail about the framework and recommendations in the checklist. A glossary of key terms and a recommended iterations table are provided in supplemental online only materials.

Emulating 3 Clinical Trials That Compare Stroke Rehabilitation at Inpatient Rehabilitation Facilities With Skilled Nursing Facilities.

OBJECTIVE: To inform the design of a potential future randomized controlled trial (RCT), we emulated 3 trials where patient-level outcomes were compared after stroke rehabilitation at inpatient rehabilitation facilities (IRFs) with skilled nursing facilities (SNFs). DESIGN: Trials were emulated using a 1:1 matched propensity score analysis. The 3 trials differed because facilities from rehabilitation networks with different case volumes were compared. Rehabilitation network case volumes were based on the number of patients with stroke that each hospital discharged to each specific IRF or SNF. Trial 1 included 60,529 patients from all networks, trial 2 included 34,444 patients from networks with medium and large case volumes (ie, ≥5 patients), and trial 3 included 19,161 patients from networks with large case volumes (ie, ≥10 patients). The E values were calculated to estimate the minimum strength that an unmeasured confounder would need to be to nullify the results. SETTING: A national sample of IRFs and SNFs from across the United States. PARTICIPANTS: Fee-for-service Medicare patients with acute stroke who received IRF or SNF based rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: One-year successful community discharge (home for >30 consecutive days) and all-cause mortality. RESULTS: Overall, 29,500, 15,156, and 7450 patients were matched for trials 1, 2, and 3. For 1-year successful community discharge, absolute risk differences for IRF patients were 0.21 (95% CI, 0.20-0.22), 0.17 (95% CI, 0.16-0.19), and 0.12 (95% CI, 0.10-0.14) in trials 1, 2, and 3, respectively. For 1-year all-cause mortality, corresponding risk differences were -0.11 (95% CI, -0.12 to -0.11), -0.11 (95% CI, -0.12 to -0.09), and -0.08 (95% CI, -0.10 to -0.06). The E values indicated that a moderately sized unmeasured confounder, with a relative risk of 1.6-2.0 would nullify differences in successful community discharge. CONCLUSIONS: IRF patients had superior outcomes, but differences were attenuated when IRFs and SNFs from larger rehabilitation networks were compared. The vulnerability of the findings to unmeasured confounding supports the need for an RCT.

Physical Function Recovery Trajectories After Spinal Cord Injury.

OBJECTIVE: To explore trajectories of functional recovery that occur during the first 2 years after spinal cord injury (SCI). DESIGN: Observational cohort study. SETTING: Eight SCI Model System sites. PARTICIPANTS: A total of 479 adults with SCI completed 4 Spinal Cord Injury-Functional Index (SCI-FI) item banks within 4 months of injury and again at 2 weeks, 3, 6, 12, and 24 months after baseline assessment (N=479). INTERVENTION: None. MAIN OUTCOME MEASURES: SCI-FI Basic Mobility/Capacity (C), Fine Motor Function/C, Self-care/C, and Wheelchair Mobility/Assistive Technology (AT) item banks. RESULTS: Growth mixture modeling was used to identify groups with similar trajectory patterns. For the Basic Mobility/C and Wheelchair Mobility/AT domains, models specifying 2 trajectory groups were selected. For both domains, a majority class exhibited average functional levels and gradual improvement, primarily in the first 6 months. A smaller group of individuals made gradual improvements but had greater initial functional limitations. The Self Care/C domain exhibited a similar pattern; however, a third, small class emerged that exhibited substantial improvement in the first 6 months. Finally, for individuals with tetraplegia, trajectories of Fine Motor Function/C scores followed 2 patterns, with individuals reporting generally low initial scores and then making either modest or large improvements. In individual growth curve models, injury/demographic factors predicted initial functional levels but less so regarding rates of recovery. CONCLUSIONS: Trajectories of functional recovery followed a small number of change patterns, although variation around these patterns emerged. During the first 2 years after initial hospitalization, SCI-FI scores showed modest improvements; however, substantial improvements were noted for a small number of individuals with severe limitations in fine motor and self-care function. Future studies should further explore the personal, medical, and environmental characteristics that influence functional trajectories during these first 2 years and beyond.

Rationale for a Clinical Trial That Compares Acute Stroke Rehabilitation at Inpatient Rehabilitation Facilities to Skilled Nursing Facilities: Challenges and Opportunities.

In the United States, approximately 400,000 patients with acute stroke are discharged annually to inpatient rehabilitation facilities (IRFs) or skilled nursing facilities (SNFs). Typically, IRFs provide time-intensive therapy for an average of 2-3 weeks, whereas SNFs provide more moderately intensive therapy for 4-5 weeks. The factors that influence discharge to an IRF or SNF are multifactorial and poorly understood. The complexity of these factors in combination with subjective clinical indications contributes to large variations in the use of IRFs and SNFs. This has significant financial implications for health care expenditure, given that stroke rehabilitation at IRFs costs approximately double that at SNFs. To control health care spending without compromising outcomes, the Institute of Medicine has stated that policy reforms that promote more efficient use of IRFs and SNFs are critically needed. A major barrier to the formulation of such policies is the highly variable and low-quality evidence for the comparative effectiveness of IRF- vs SNF-based stroke rehabilitation. The current evidence is limited by the inability of observational data to control for residual confounding, which contributes to substantial uncertainty around any magnitude of benefit for IRF- vs SNF-based care. Furthermore, it is unclear which specific patients would receive the most benefit from each setting. A randomized controlled trial addresses these issues, because random treatment allocation facilitates an equitable distribution of measured and unmeasured confounders. We discuss several measurement, practical, and ethical issues of a trial and provide our rationale for design suggestions that overcome some of these issues.

Participation by design: Integrating a social ecological approach with universal design to increase participation and add value for consumers.

BACKGROUND: Physical activity is an essential component of a healthy lifestyle. Health clubs encourage sustained healthy lifestyles but are still largely not accessible to people with disabilities. Cost is a barrier for accessibility enhancements. HYPOTHESIS: We postulate that: (A) universal design coupled with a social ecological approach improves measured accessibility compared with existing fitness facilities constructed since the adoption of the ADA; (B) increased accessibility coupled with an environment friendly to people with disabilities attracts more participants to a YMCA than predicted by traditional industry market research producing a recovery of the cost of increased accessibility; and (C) attitudes of facility members toward people with disabilities may improve if an accessible facility facilitates more personal interactions between people with and without disabilities. METHODS: Accessibility is measured with the Accessibility Instruments Measuring Fitness and Recreation Environments (AIMFREE). Cost recovery is determined by comparing excess membership revenue to the cost of universal design elements beyond regulatory requirements, and attitudes toward people with disabilities are measured with the Attitudes Toward Disabled Persons Scale. RESULTS: AIMFREE scores were significantly higher than comparison facilities in all areas except for equipment, parking, training, and programs. Excess revenue exceeded the extra cost of accessibility enhancements and attitudes toward people with disabilities did not change. CONCLUSIONS: Universal design coupled with a social ecological approach improves accessibility in fitness facilities and results in a reasonable payback time. Attitudes toward people with disabilities did not change in a YMCA designed to accommodate people with disabilities.

Safety and feasibility of exoskeleton-assisted walking during acute/sub-acute SCI in an inpatient rehabilitation facility: A single-group preliminary study.

Context/objective: Information on the safety and feasibility of lower extremity powered exoskeletons for persons with acute/sub-acute spinal cord injury (SCI) is limited. Understanding the safety and feasibility of employing powered exoskeletons in acute/sub-acute (<6 months post injury) at a SCI acute inpatient rehabilitation (SCI-AIR) facility could guide clinical practice and provide a basis for larger clinical trials on efficacy and effectiveness. Design: Single group observational study. Setting: SCI-AIR. Participants: Participants (n = 12; age: 28-71 years; 58% AIS D; 58% male) with neurological levels of injuries ranging from C2 to L3. Interventions: Up to 90 min of exoskeleton-assisted locomotor training was provided up to three times per week during SCI-AIR. Outcome measures: Safety of device use during inpatient locomotor training was quantified as the number of adverse events (AE) per device exposure hour. Feasibility of device use was defined in terms of protocol compliance, intensity, and proficiency. Results: Concerning safety, symptomatic hypotension was the most common AE reported at 111-events/exoskeleton-hours. Protocol compliance had a mean (SD) of 54% (30%). For intensity, 77% of participants incorporated variable assistance into at least 1 walking session; 70% of participants' sessions were completed with a higher RPE than the physical therapist. In proficiency, 58% achieved at least minimal assistance when walking with the device. Conclusion: Exoskeleton training in SCI-AIR can be safe and feasible for newly injured individuals with SCI who have clinically defined ambulatory goals. Nonetheless, sufficient controls to minimize risks for AEs, such as hypotensive events, are required.

Measuring Value in Postacute Care.

The value of postacute care (PAC) is unclear. While experienced clinicians understand the appropriateness of each specific site of PAC, clear evidence-based guidelines are not available, and many referrals to PAC today are made based on bed availability rather than patient need. Measuring value (value=outcomes/cost) for the entire episode of care has been proposed as an effective method to both evaluate and enable faster innovation in care. Instituting value-based care will increase patient engagement, improve quality and reduce cost with the potential of unifying the goals for all stakeholders-patients and families, providers, and payers. To achieve a goal of value-based care, rehabilitation researchers will need to measure outcomes and cost for the entire episode of care. Recent laudable efforts by the Centers for Medicare & Medicaid Services (CMS) to standardize data across PAC may not include the entire episode of care since outpatient care and measurement from home are not included. In addition, the true cost of services delivered is rarely measured. To implement value-based care in rehabilitation and facilitate cost-effective care improvements, outcomes research in PAC should focus on 4 areas. First, outcome measures need to reflect the patient's perspective. Second, new methods must be implemented to acquire comparable valid and reliable data from all postacute settings and the home. Third, a predictive model for individual patients should be utilized to guide patient referral from acute care to PAC and monitor progress. And fourth, timely specific measures of true cost (resources consumed) for the outcomes achieved are needed.

Feasibility and Safety of a Powered Exoskeleton for Assisted Walking for Persons With Multiple Sclerosis: A Single-Group Preliminary Study.

OBJECTIVE: To examine the feasibility, safety, and secondary benefit potential of exoskeleton-assisted walking with one device for persons with multiple sclerosis (MS). DESIGN: Single-group longitudinal preliminary study with 8-week baseline, 8-week intervention, and 4-week follow-up. SETTING: Outpatient MS clinic, tertiary care hospital. PARTICIPANTS: Participants (N=13; age range, 38-62y) were mostly women with Expanded Disability Status Scale scores ranging from 5.5 to 7.0. INTERVENTION: Exoskeleton-assisted walk training. MAIN OUTCOME MEASURES: Primary outcomes were accessibility (enrollment/screen pass), tolerability (completion/dropout), learnability (time to event for standing, walking, and sitting with little or no assistance), acceptability (satisfaction on the device subscale of the Quebec User Evaluation of Satisfaction with Assistive Technology version 2), and safety (event rates standardized to person-time exposure in the powered exoskeleton). Secondary outcomes were walking without the device (timed 25-foot walk test and 6-minute walk test distance), spasticity (Modified Ashworth Scale), and health-related quality of life (Patient-Reported Outcomes Measurement and Information System pain interference and Quality of Life in Neurological Conditions fatigue, sleep disturbance, depression, and positive affect and well-being). RESULTS: The device was accessible to 11 and tolerated by 5 participants. Learnability was moderate, with 5 to 15 sessions required to walk with minimal assistance. Safety was good; the highest adverse event rate was for skin issues at 151 per 1000 hours' exposure. Acceptability ranged from not very satisfied to very satisfied. Participants who walked routinely improved qualitatively on sitting, standing, or walking posture. Two participants improved and 2 worsened on ≥1 quality of life domain. The pattern of spasticity scores may indicate potential benefit. CONCLUSIONS: The device appeared feasible and safe for about a third of our sample, for whom routine exoskeleton-assisted walking may offer secondary benefits.

Validation of a pain mechanism classification system (PMCS) in physical therapy practice.

The objective of this study was to validate the clinical application of a pain mechanism classification system (PMCS) in clinical practice. We analyzed data abstracted from the medical records of patients who were treated in the outpatient clinics of a large urban rehabilitation hospital in Chicago. We hypothesized that there would be good agreement between the PMCS determined by trained therapists and the PMCS category assigned based on a computer-generated statistical model using patients' signs and symptoms. Using cluster analysis, when we assumed five groups, 97% of patients could be classified. Sensitivity and specificity results with 95% confidence intervals were calculated for the categories using the physical therapist assigned categories (PMCS) as the criterion standard. Sensitivity for four of the five categories (inflammatory, ischemia, peripheral neurogenic, and other ranged from 72·0 to 83·1%). For the central mechanism, sensitivity was much lower at 15%. Specificity for the five categories ranged from 72·4% (ischemia) to 98·8% (central). This study provides empirical support for recent findings in the literature that the peripheral components of a PMCS can be implemented consistently in an outpatient pain clinical practice.

Trajectories of Life Satisfaction After Spinal Cord Injury.

OBJECTIVE: To describe individual-level temporal change in life satisfaction after spinal cord injury. DESIGN: Individual growth curve (IGC) analysis of prospectively collected data from the National Institute on Disability, Independent Living, and Rehabilitation Research National Spinal Cord Injury Database (NSCID). SETTING: Multicenter, longitudinal database study. PARTICIPANTS: Participants (N=4846) in the NSCID. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Rasch-transformed Satisfaction With Life Scale scores. RESULTS: Individual-level trajectories reflecting life satisfaction vary extensively and are associated with demographic and injury-related characteristics. Demographic characteristics include race, sex, pre-employment and discharge marital status, and level of education; injury-related factors include days in rehabilitation, neurologic level, age at injury, and injury etiology. Results are displayed graphically by way of a computer-generated interactive tool and represent different trajectories of individual-level changes in life satisfaction. CONCLUSIONS: IGC methodology allows researchers and clinicians to anticipate patient-specific trajectories through use of an automated interactive tool. Projected trajectories hold promise in facilitating planning for inpatient and outpatient services, which could enhance long-term outcomes.

Evaluating Individual Change With the Quality of Life in Neurological Disorders (Neuro-QoL) Short Forms.

OBJECTIVE: To provide a clinically useful means of interpreting change for individual patients on the Quality of Life in Neurological Disorders (Neuro-QoL) adult short forms (SFs) by applying a classical test theory concept for interpreting individual change. DESIGN: Secondary analysis of existing data. SETTING: Community. PARTICIPANTS: Persons with neurologic conditions including stroke, epilepsy, amyotrophic lateral sclerosis, multiple sclerosis, and Parkinson disease residing in community settings. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Neuro-QoL SFs for Applied Cognition-General Concerns, Applied Cognition-Executive Function, Applied Cognition-Combined, Ability to Participate in Social Roles and Activities, Satisfaction With Social Roles and Activities, Positive Affect and Well-Being, Depression, Stigma, Upper Extremity Function (Fine Motor, Activities of Daily Living), Lower Extremity Function (Mobility), Anxiety, Sleep Disturbance, Fatigue, and Emotional and Behavioral Dyscontrol. We estimated conditional minimal detectable change (cMDC) indices from the pooled SEs adjusted for a 95% confidence interval using the average of the SEs for any given pair of scores multiplied by the z score, or ([SE(Score1) + SE(Score2)]/2) * (1.96) * (SQRT(2)). RESULTS: The cMDC indices are generally smallest in the midrange of all scales, ranging from 3.6 to 11.2 T-score points, and higher on the outer quartiles ranging from 3.7 to 21.6 T-score points. The lowest midrange cMDCs were for Satisfaction With Social Roles and Activities (3.6-4.7 T-score points), and the largest were for Sleep Disturbance (9.4-11.2 T-score points). CONCLUSIONS: Change indices can help clinicians and investigators identify differences for individual patients or subjects that are large enough to motivate treatment change. cMDCs can reduce misclassification of magnitudes of change that are near the margins of error across the range of the Neuro-QoL SFs.

A Multidimensional Rasch Analysis of the Functional Independence Measure Based on the National Institute on Disability, Independent Living, and Rehabilitation Research Traumatic Brain Injury Model Systems National Database.

A number of studies have evaluated the psychometric properties of the Functional Independence Measure (FIM™) using Rasch analysis, although none has done so using the National Institute on Disability, Independent Living, and Rehabilitation Research Traumatic Brain Injury Model Systems National Database, a longitudinal database that captures demographic and outcome information on persons with moderate to severe traumatic brain injury across the United States. In the current study, we examine the psychometric properties of the FIM as represented by persons within this database and demonstrate that the FIM comprises three subscales representing cognitive, self-care, and mobility domains. These subscales were analyzed simultaneously using a multivariate Rasch model in combination with a time dependent concurrent calibration scheme with the goal of creating a raw score-to-logit transformation that can be used to improve the accuracy of parametric statistical analyses. The bowel and bladder function items were removed because of misfit with the motor and cognitive items. Some motor items exhibited step disorder, which was addressed by collapsing Categories 1-3 for Toileting, Stairs, Locomotion, Tub/Shower Transfers; Categories 1 and 2 for Toilet and Bed Transfers; and Categories 2 and 3 for Grooming. The strong correlations (r = 0.82-0.96) among the three subscales suggest they should be modeled together. Coefficient alpha of 0.98 indicates high internal consistency. Keyform maps are provided to enhance clinical interpretation and application of study results.

Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking.

BACKGROUND: Powered exoskeletons have been demonstrated as being safe for persons with spinal cord injury (SCI), but little is known about how users learn to manage these devices. OBJECTIVE: To quantify the time and effort required by persons with SCI to learn to use an exoskeleton for assisted walking. METHODS: A convenience sample was enrolled to learn to use the first-generation Ekso powered exoskeleton to walk. Participants were given up to 24 weekly sessions of instruction. Data were collected on assistance level, walking distance and speed, heart rate, perceived exertion, and adverse events. Time and effort was quantified by the number of sessions required for participants to stand up, walk for 30 minutes, and sit down, initially with minimal and subsequently with contact guard assistance. RESULTS: Of 22 enrolled participants, 9 screen-failed, and 7 had complete data. All of these 7 were men; 2 had tetraplegia and 5 had motor-complete injuries. Of these, 5 participants could stand, walk, and sit with contact guard or close supervision assistance, and 2 required minimal to moderate assistance. Walk times ranged from 28 to 94 minutes with average speeds ranging from 0.11 to 0.21 m/s. For all participants, heart rate changes and reported perceived exertion were consistent with light to moderate exercise. CONCLUSIONS: This study provides preliminary evidence that persons with neurological weakness due to SCI can learn to walk with little or no assistance and light to somewhat hard perceived exertion using a powered exoskeleton. Persons with different severities of injury, including those with motor complete C7 tetraplegia and motor incomplete C4 tetraplegia, may be able to learn to use this device.