Defining paediatric neurorehabilitation: You cannot improve what you cannot characterize.

Neurorehabilitation is the primary therapy for neurological impairment in children, yet its potential to achieve change remains incompletely understood and probably underestimated. Understanding 'the difference neurorehabilitation can make' against a background of neurological repair and recovery as well as ongoing neurological development is an enormous challenge, exacerbated to no small extent by the lack of a 'common currency' for the description and measurement of the neurorehabilitation services a child is receiving. This review addresses attempts to parse neurorehabilitation treatment content in theoretically and mechanistically valid ways that might help address this challenge.

Rehabilitation Treatment Specification System: Content and Criterion Validity Across Evidence-Based Voice Therapies for Muscle Tension Dysphonia.

PURPOSE: Systematically improving voice therapy outcomes is challenging as the clinician actions (i.e., active ingredients) responsible for improved patient functioning (i.e., targets) are relatively unknown. The theory-driven Rehabilitation Treatment Specification System (RTSS) and standard, voice-specific terminology based on the RTSS (RTSS-Voice) may help address this problem. This qualitative study evaluated if the RTSS and RTSS-Voice can describe four evidence-based voice therapies for muscle tension dysphonia without missing critical aspects (content validity) and identify commonalities and differences across them (criterion validity). METHOD: Qualitative interviews were completed between the clinicians (protocol experts) who developed and/or popularized the vocal function exercises, laryngeal reposturing, circumlaryngeal massage, and conversation training therapies as well as RTSS experts to produce RTSS specifications that met two consensus criteria: (a) The protocol expert agreed that the specification represented their treatment theory, and (b) the RTSS experts agreed that the specifications correctly adhered to both the RTSS framework and the RTSS-Voice's standard terminology. RESULTS: The RTSS and RTSS-Voice comprehensively described voice therapy variations across and within the four diverse treatment programs, needing only the addition of one new target: overall auditory-perceptual severity. CONCLUSIONS: The RTSS and RTSS-Voice exhibited strong content validity. The standard RTSS-Voice terminology helped identify, for the first time, commonalities and differences in treatment ingredients, targets, and mechanisms of action across four treatments developed for the same patient population. In the long term, the RTSS and RTSS-Voice could provide the framework for an ever-growing collection of clinically meaningful and evidence-based therapy algorithms with potential to improve research, education, and clinical care. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.25537624.

Common Data Element for Disorders of Consciousness: Recommendations from the Working Group on Therapeutic Interventions.

BACKGROUND: Over the past 30 years, there have been significant advances in the understanding of the mechanisms associated with loss and recovery of consciousness following severe brain injury. This work has provided a strong grounding for the development of novel restorative therapeutic interventions. Although all interventions are aimed at modulating and thereby restoring brain function, the landscape of existing interventions encompasses a very wide scope of techniques and protocols. Despite vigorous research efforts, few approaches have been assessed with rigorous, high-quality randomized controlled trials. As a growing number of exploratory interventions emerge, it is paramount to develop standardized approaches to reporting results. The successful evaluation of novel interventions depends on implementation of shared nomenclature and infrastructure. To address this gap, the Neurocritical Care Society's Curing Coma Campaign convened nine working groups and charged them with developing common data elements (CDEs). Here, we report the work of the Therapeutic Interventions Working Group. METHODS: The working group reviewed existing CDEs relevant to therapeutic interventions within the National Institutes of Health National Institute of Neurological Disorders and Stroke database and reviewed the literature for assessing key areas of research in the intervention space. CDEs were then proposed, iteratively discussed and reviewed, classified, and organized in a case report form (CRF). RESULTS: We developed a unified CRF, including CDEs and key design elements (i.e., methodological or protocol parameters), divided into five sections: (1) patient information, (2) general study information, (3) behavioral interventions, (4) pharmacological interventions, and (5) device interventions. CONCLUSIONS: The newly created CRF enhances systematization of future work by proposing a portfolio of measures that should be collected in the development and implementation of studies assessing novel interventions intended to increase the level of consciousness or rate of recovery of consciousness in patients with disorders of consciousness.

The Temporal Relationship Between Moderate to Vigorous Physical Activity and Secondary Conditions During the First Year After Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To determine the cross-sectional and temporal relationships between minutes per week of moderate to vigorous physical activity (MVPA) as measured by a wrist-worn accelerometer and secondary conditions in the first year after moderate to severe traumatic brain injury (TBI). DESIGN: Prospective longitudinal cohort study. SETTING: Four inpatient rehabilitation centers. PARTICIPANTS: Individuals (N = 180) with moderate-severe TBI enrolled in the TBI Model Systems Study. INTERVENTIONS: Participants wore a wrist accelerometer for 7 days immediately post discharge, and for 7 consecutive days at 6- and 12-months post injury. MAIN OUTCOME MEASURES: Minutes per week of MVPA from daily averages based on wrist worn accelerometer. Secondary conditions included depression (Patient Health Questionnaire-9), fatigue (PROMIS Fatigue), Pain (Numeric Rating Scale), Sleep (Pittsburgh Sleep Quality Index), and cognition (Brief Test of Adult Cognition by Telephone). RESULTS: At baseline, 6 and 12 months, 61%, 70% and 79% of the sample achieved at least 150 minutes per week of MVPA. The correlations between minutes of MVPA between baseline, 6 and 12 months were significant (r = 0.53-0.73), as were secondary conditions over these time points. However, no significant correlations were observed between minutes of MVPA and any secondary outcomes cross-sectionally or longitudinally at any time point. CONCLUSIONS: Given the robust relationships physical activity has with outcomes in the general population, further research is needed to understand the effect of physical activity in individuals with moderate-severe TBI.

Rehabilitation Treatment Specification System for Voice Therapy: Application to Everyday Clinical Care.

PURPOSE: Rehabilitation intervention descriptions often do not explicitly identify active ingredients or how those ingredients lead to changes in patient functioning. The Rehabilitation Treatment Specification System (RTSS) provides guidance to identify the critical aspects of any rehabilitation therapy and supported the development of standardly named ingredients and targets in voice therapy (Rehabilitation Treatment Specification System for Voice Therapy [RTSS-Voice]). This study sought to test the content validity of the RTSS-Voice and determine if the RTSS-Voice can be used to identify commonalities and differences in treatment (criterion validity) across clinicians in everyday clinical practice. METHOD: Five speech-language pathologists from different institutions videotaped one therapy session for 59 patients diagnosed with a voice or upper airway disorder. Specifications were created for each video, and iterative rounds of revisions were completed with the treating clinician and two RTSS experts until consensus was reached on each specification. RESULTS: All 59 sessions were specified without the addition of any targets or ingredients. There were two frequent targets: (a) increased volition and (b) decreased strained voice quality. There were three frequent ingredients: (a) information regarding the patient's capability and motivation to perform a therapeutic behavior, (b) knowledge of results feedback, and (c) opportunities to practice voicing with improved resonance and mean airflow. Across sessions treating vocal hyperfunction, there was large variability across clinicians regarding the types and number of treatment components introduced, types of feedback provided, and vocal practice within spontaneous speech and negative practice. CONCLUSIONS: The RTSS and the RTSS-Voice demonstrated strong content validity, as they comprehensively characterized 59 therapy sessions. They also demonstrated strong criterion validity, as commonalities and differences were identified in everyday voice therapy for vocal hyperfunction across multiple clinicians. Future work to translate RTSS principles and RTSS-Voice terms into clinical documentation can help to understand how clinician and patient variability impacts outcomes and bridge the research-practice gap. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.24796875.

Spatiotemporal profile of atrophy in the first year following moderate-severe traumatic brain injury.

Traumatic brain injury (TBI) triggers progressive neurodegeneration resulting in brain atrophy that continues months-to-years following injury. However, a comprehensive characterization of the spatial and temporal evolution of TBI-related brain atrophy remains incomplete. Utilizing a sensitive and unbiased morphometry analysis pipeline optimized for detecting longitudinal changes, we analyzed a sample consisting of 37 individuals with moderate-severe TBI who had primarily high-velocity and high-impact injury mechanisms. They were scanned up to three times during the first year after injury (3 months, 6 months, and 12 months post-injury) and compared with 33 demographically matched controls who were scanned once. Individuals with TBI already showed cortical thinning in frontal and temporal regions and reduced volume in the bilateral thalami at 3 months post-injury. Longitudinally, only a subset of cortical regions in the parietal and occipital lobes showed continued atrophy from 3 to 12 months post-injury. Additionally, cortical white matter volume and nearly all deep gray matter structures exhibited progressive atrophy over this period. Finally, we found that disproportionate atrophy of cortex along sulci relative to gyri, an emerging morphometric marker of chronic TBI, was present as early as 3 month post-injury. In parallel, neurocognitive functioning largely recovered during this period despite this pervasive atrophy. Our findings demonstrate msTBI results in characteristic progressive neurodegeneration patterns that are divergent across regions and scale with the severity of injury. Future clinical research using atrophy during the first year of TBI as a biomarker of neurodegeneration should consider the spatiotemporal profile of atrophy described in this study.

Temporal dynamics of cerebral blood flow during the first year after moderate-severe traumatic brain injury: A longitudinal perfusion MRI study.

Traumatic brain injury (TBI) is associated with alterations in cerebral blood flow (CBF), which may underlie functional disability and precipitate TBI-induced neurodegeneration. Although it is known that chronic moderate-severe TBI (msTBI) causes decreases in CBF, the temporal dynamics during the early chronic phase of TBI remain unknown. Using arterial spin labeled (ASL) perfusion magnetic resonance imaging (MRI), we examined longitudinal CBF changes in 29 patients with msTBI at 3, 6, and 12 months post-injury in comparison to 35 demographically-matched healthy controls (HC). We investigated the difference between the two groups and the within-subject time effect in the TBI patients using whole-brain voxel-wise analysis. Mean CBF in gray matter (GM) was lower in the TBI group compared to HC at 6 and 12 months post-injury. Within the TBI group, we identified widespread regional decreases in CBF from 3 to 6 months post-injury. In contrast, there were no regions with decreasing CBF from 6 to 12 months post-injury, indicating stabilization of hypoperfusion. There was instead a small area of increase in CBF observed in the right precuneus. These CBF changes were not accompanied by cortical atrophy. The change in CBF was correlated with change in executive function from 3 to 6 months post-injury in TBI patients, suggesting functional relevance of CBF measures. Understanding the time course of TBI-induced hypoperfusion and its relationship with cognitive improvement could provide an optimal treatment window to benefit long-term outcome.

Rehabilitation Treatment Specification System: Identifying Barriers, Facilitators, and Strategies for Implementation in Research, Education, and Clinical Care.

OBJECTIVE: To explore rehabilitation professionals' experiences and perspectives of barriers and facilitators to implementing the Rehabilitation Treatment Specification System (RTSS) in research, education, and clinical care. DESIGN: A cross-sectional survey with free text and binary responses was completed by rehabilitation professionals. Survey data were analyzed with a deductive approach of directed content analysis using 2 implementation science frameworks: Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC). SETTING: Rehabilitation professionals across research, educational, and clinical settings. PARTICIPANTS: One hundred and eleven rehabilitation professionals-including speech-language pathologists, occupational therapists, physical therapists, physicians, psychologists, researchers, and clinic directors-who explored possible uses or applications of the RTSS for clinical care, education, or research (N=111). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Frequency of reported CFIR barriers and facilitators, as well as keywords related to CFIR and ERIC constructs. RESULTS: The barriers and facilitating strategies differed according to the end-users' intended use, that is, research, education, or clinical. Overall, the 4 most frequently encountered CFIR barriers were the RTSS's complexity, a lack of available RTSS resources, reduced access to knowledge and information about the RTSS, and limited knowledge and beliefs about the RTSS. The ERIC-CFIR matching tool identified 7 ERIC strategies to address these barriers, which include conducting educational meetings, developing and distributing educational materials, accessing new funding, capturing and sharing local knowledge, identifying and preparing champions, and promoting adaptability. CONCLUSIONS: When attempting to use the RTSS, rehabilitation professionals commonly encountered barriers to understanding and skillfully using the framework. Theory-driven implementation strategies have been identified that have potential for addressing the RTSS's complexity and lack of educational and skill-building resources. Future work can develop the identified implementation strategies and evaluate their effects on RTSS implementation.

Examining the Evidence From Single-Case Experimental Designs to Treat Challenging Behaviors Following Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To evaluate evidence on the effectiveness of behavioral interventions using single-case experimental design (SCED) methodology and to identify behavioral interventions with sufficient evidence for possible inclusion in the development of guidelines for the management of challenging behaviors in adults following moderate to severe traumatic brain injury (TBI). METHODS: As a subinvestigation of a larger systematic review process designed to identify evidence for guidelines development, the current review focused on studies using SCED methodology applied to persons with challenging behaviors following moderate to severe TBI. Articles were identified from a search of the published literature through January 2021, identifying studies in CINAHL, Cochrane Database of Systematic Reviews, EMBASE, MEDLINE/Ovid, and PsycINFO. Articles meeting inclusion criteria were assessed for design rigor to allow for effect size determination. The identified cases were then critically appraised using the RoBiNT (Risk-of-Bias in N-of-1 Trails) Scale to determine strength of evidence for causal inference. RESULTS: Thirty-four studies met inclusion criteria, with a total of 44 cases evaluated for effect of the treatment intervention on defined target behaviors. Seventeen cases had effect sizes rated as large, 22 cases as medium, 3 cases as small, and 3 as no effect. An observed trend was for large and medium effect sizes to be associated with lower RoBiNT Scale internal validity scores. Randomization, blinded provider and assessor, and assessment of treatment adherence were the internal validity items unlikely to meet criteria. CONCLUSIONS: SCED methodology was found to produce large and medium effect sizes for behavioral interventions targeting challenging behaviors following moderate to severe TBI. However, the strength of the evidence is limited because of weaknesses in study designs. Most of the studies failed to meet established internal validity criteria designed to reduce risk of bias in SCED studies as such rigor is difficult to establish or often not practical in clinical settings. Suggestions and recommendations are outlined for improving the quality of published cases using SCED methodology, which, in turn, will improve credibility of evidence and better inform the development of treatment guidelines for behavior regulation.

Feasibility and Utility of a Flexible Outcome Assessment Battery for Longitudinal Traumatic Brain Injury Research: A TRACK-TBI Study.

The effects of traumatic brain injury (TBI) are difficult to measure in longitudinal cohort studies, because disparate pre-injury characteristics and injury mechanisms produce variable impairment profiles and recovery trajectories. In preparation for the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, which followed patients with injuries ranging from uncomplicated mild TBI to coma, we designed a multi-dimensional Flexible outcome Assessment Battery (FAB). The FAB relies on a decision-making algorithm that assigns participants to a Comprehensive (CAB) or Abbreviated Assessment Battery (AAB) and guides test selection across all phases of recovery. To assess feasibility of the FAB, we calculated the proportion of participants followed at 2 weeks (2w) and at 3, 6, and 12 months (3m, 6m, 12m) post-injury who completed the FAB and received valid scores. We evaluated utility of the FAB by examining differences in 6m and 12m Glasgow Outcome Scale-Extended (GOSE) scores between participant subgroups derived from the FAB-enabled versus traditional approach to outcome assessment applied at 2w. Among participants followed at 2w (n = 2094), 3m (n = 1871), 6m (n = 1736), and 12m (n = 1607) post-injury, 95-99% received valid completion scores on the FAB, in full or in part, either in person or by telephone. Level of function assessed by the FAB-enabled approach at 2w was associated with 6m and 12m GOSE scores (proportional odds p < 0.001). These findings suggest that the participant classification methodology afforded by the FAB may enable more effective data collection to improve detection of natural history changes and TBI treatment effects.

Developing a National Trauma Research Action Plan: Results from the long-term outcomes research gap Delphi survey.

BACKGROUND: In the National Academies of Sciences, Engineering, and Medicine 2016 report on trauma care, the establishment of a National Trauma Research Action Plan to strengthen and guide future trauma research was recommended. To address this recommendation, the Department of Defense funded the Coalition for National Trauma Research to generate a comprehensive research agenda spanning the continuum of trauma and burn care. We describe the gap analysis and high-priority research questions generated from the National Trauma Research Action Plan panel on long-term outcomes. METHODS: Experts in long-term outcomes were recruited to identify current gaps in long-term trauma outcomes research, generate research questions, and establish the priority for these questions using a consensus-driven, Delphi survey approach from February 2021 to August 2021. Panelists were identified using established Delphi recruitment guidelines to ensure heterogeneity and generalizability including both military and civilian representation. Panelists were encouraged to use a PICO format to generate research questions: Patient/Population, Intervention, Compare/Control, and Outcome model. On subsequent surveys, panelists were asked to prioritize each research question on a 9-point Likert scale, categorized to represent low-, medium-, and high-priority items. Consensus was defined as ≥60% of panelists agreeing on the priority category. RESULTS: Thirty-two subject matter experts generated 482 questions in 17 long-term outcome topic areas. By Round 3 of the Delphi, 359 questions (75%) reached consensus, of which 107 (30%) were determined to be high priority, 252 (70%) medium priority, and 0 (0%) low priority. Substance abuse and pain was the topic area with the highest number of questions. Health services (not including mental health or rehabilitation) (64%), mental health (46%), and geriatric population (43%) were the topic areas with the highest proportion of high-priority questions. CONCLUSION: This Delphi gap analysis of long-term trauma outcomes research identified 107 high-priority research questions that will help guide investigators in future long-term outcomes research. LEVEL OF EVIDENCE: Diagnostic Tests or Criteria; Level IV.

Determining the Hierarchy of Coma Recovery Scale-Revised Rating Scale Categories and Alignment with Aspen Consensus Criteria for Patients with Brain Injury: A Rasch Analysis.

This study aimed to empirically evaluate the hierarchical structure of the Coma Recovery Scale-Revised (CRS-R) rating scale categories and their alignment with the Aspen consensus criteria for determining disorders of consciousness (DoC) following a severe brain injury. CRS-R data from 262 patients with DoC following a severe brain injury were analyzed applying the partial credit Rasch Measurement Model. Rasch Analysis produced logit calibrations for each rating scale category. Twenty-eight of the 29 CRS-R rating scale categories were operationalized to the Aspen consensus criteria. We expected the hierarchical order of the calibrations to reflect Aspen consensus criteria. We also examined the association between the CRS-R Rasch person measures (indicative of performance ability) and states of consciousness as determined by the Aspen consensus criteria. Overall, the order of the 29 rating scale category calibrations reflected current literature regarding the continuum of neurobehavioral function: category 6 "Functional Object Use" of the Motor item was hardest for patients to achieve; category 0 "None" of the Oromotor/Verbal item was easiest to achieve. Of the 29 rating scale categories, six were not ordered as expected. Four rating scale categories reflecting the Vegetative State (VS)/Unresponsive Wakefulness Syndrome (UWS) had higher calibrations (reflecting greater neurobehavioral function) than the easiest Minimally Conscious State (MCS) item (category 2 "Fixation" of the Visual item). Two rating scale categories, one reflecting MCS and one not operationalized to the Aspen consensus criteria, had higher calibrations than the easiest eMCS item (category 2 "Functional: Accurate" of the Communication item). CRS-R person measures (indicating amount of neurobehavioral function) and states of consciousness, based on Aspen consensus criteria, showed a strong correlation (rs = 0.86; p < 0.01). Our study provides empirical evidence for revising the diagnostic criteria for MCS to also include category 2 "Localization to Sound" of the Auditory item and for Emerged from Minimally Conscious State (eMCS) to include category 4 "Consistent Movement to Command" of the Auditory item.

Treatment Trials in Disorders of Consciousness: Challenges and Future Directions.

The evidence base supporting treatment interventions for patients with disorders of consciousness is limited, and rigorous treatment trials are needed to guide future management of this complex patient population. There are many potential study designs that can be employed to develop this evidence, but the process of selecting the optimal study design is challenging. This article reviews common obstacles that impede research progress in this population and a range of study designs that may be employed. In addition, we consider how the particular practical and scientific obstacles may drive selection of the optimal design and, in particular, how the optimal design changes as treatment research proceeds along the translational continuum from mechanistic discovery to real-world clinical impact.

Connectomic assessment of injury burden and longitudinal structural network alterations in moderate-to-severe traumatic brain injury.

Traumatic brain injury (TBI) is a major public health problem. Caused by external mechanical forces, a major characteristic of TBI is the shearing of axons across the white matter, which causes structural connectivity disruptions between brain regions. This diffuse injury leads to cognitive deficits, frequently requiring rehabilitation. Heterogeneity is another characteristic of TBI as severity and cognitive sequelae of the disease have a wide variation across patients, posing a big challenge for treatment. Thus, measures assessing network-wide structural connectivity disruptions in TBI are necessary to quantify injury burden of individuals, which would help in achieving personalized treatment, patient monitoring, and rehabilitation planning. Despite TBI being a disconnectivity syndrome, connectomic assessment of structural disconnectivity has been relatively limited. In this study, we propose a novel connectomic measure that we call network normality score (NNS) to capture the integrity of structural connectivity in TBI patients by leveraging two major characteristics of the disease: diffuseness of axonal injury and heterogeneity of the disease. Over a longitudinal cohort of moderate-to-severe TBI patients, we demonstrate that structural network topology of patients is more heterogeneous and significantly different than that of healthy controls at 3 months postinjury, where dissimilarity further increases up to 12 months. We also show that NNS captures injury burden as quantified by posttraumatic amnesia and that alterations in the structural brain network is not related to cognitive recovery. Finally, we compare NNS to major graph theory measures used in TBI literature and demonstrate the superiority of NNS in characterizing the disease.