Feasibility of overground exoskeleton gait training during inpatient rehabilitation after severe acquired brain injury.

OBJECTIVE: To describe the safety, feasibility, and tolerability of overground exoskeleton gait training (OEGT) integrated into clinical practice for patients after severe acquired brain injury (ABI). SETTING: Inpatient rehabilitation hospital. PARTICIPANTS: Eligible patients with severe ABI met the following criteria: age > 18, medically stable, met exoskeleton frame limitations, and a score of ≤ 3 on the motor function portion of the Coma Recovery Scale - Revised (CRS-R). Presence of consciousness disorder was not exclusionary. DESIGN: Prospective observational study. MAIN MEASURES: Outcomes examined safety (adverse events), feasibility (session count and barriers to session completion), and tolerability of OEGT (session metrics and heart rate). RESULTS: Ten patients with ABI completed 10.4 ± 4.8 OEGT sessions with no adverse events. Barriers to session completion included clinical focus on prioritized interventions. Sessions [median up time = 17 minutes, (IQR: 7); walk time = 13 minutes, (IQR: 9); step count = 243, (IQR: 161); device assist = 74, (IQR: 28.0)] were primarily spent in Very Light to Light heart rate intensities [89%, (IQR: 42%) and 9%, (IQR: 33%), respectively]. CONCLUSION: OEGT incorporated into the rehabilitation plan of care during inpatient rehabilitation after severe ABI was observed to be safe, feasible, and tolerable. However, intentional steps must be taken to facilitate patient safety.

Utilization of overground exoskeleton gait training during inpatient rehabilitation: a descriptive analysis.

BACKGROUND: Overground exoskeleton gait training (OEGT) after neurological injury is safe, feasible, and may yield positive outcomes. However, no recommendations exist for initiation, progression, or termination of OEGT. This retrospective study highlights the clinical use and decision-making of OEGT within the physical therapy plan of care for patients after neurological injury during inpatient rehabilitation. METHODS: The records of patients admitted to inpatient rehabilitation after stroke, spinal cord injury, or traumatic brain injury who participated in at least one OEGT session were retrospectively reviewed. Session details were analyzed to illustrate progress and included: "up" time, "walk" time, step count, device assistance required for limb swing, and therapist-determined settings. Surveys were completed by therapists responsible for OEGT sessions to illuminate clinical decision-making. RESULTS: On average, patients demonstrated progressive tolerance for OEGT over successive sessions as shown by increasing time upright and walking, step count, and decreased assistance required by the exoskeleton. Therapists place preference on using OEGT with patients with more functional dependency and assess feedback from the patient and device to determine when to change settings. OEGT is terminated when other gait methods yield higher step repetitions or intensities, or to prepare for discharge. CONCLUSION: Our descriptive retrospective data suggests that patients after neurological injury may benefit from OEGT during inpatient rehabilitation. As no guidelines exist, therapists' clinical decisions are currently based on a combination of knowledge of motor recovery and experience. Future efforts should aim to develop evidence-based recommendations to facilitate functional recovery after neurological injury by leveraging OEGT.

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI).

Obesity rates after traumatic brain injury (TBI) are high and are associated with greater risk of morbidity (diabetes, hypertension) and mortality when compared to the general population. Evidence-based interventions for this population are needed and our work modifying and examining the efficacy of the Diabetes Prevention Program Group Lifestyle Balance (GLB-TBI) are promising. Our recent randomized controlled trial included 57 adults with TBI who completed the GLB-TBI in-person and lost 17.8 ± 16.4lbs (7.9% body weight) compared to the attention control (0%). To broaden the accessibility of the intervention we will complete an RCT to assess the efficacy of telehealth delivery (tGLB-TBI) by enrolling 88 participants over a 3 year period. Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health. The long-term goal is to reduce health inequities and broaden program dissemination to people with TBI that lack access due to environmental barriers, including living rurally or lacking transportation.

Efficacy of a group-based education intervention for people with traumatic brain injury: supplementary results from a 12-month randomized controlled trial.

OBJECTIVE: Our team developed an attention control condition, called the Brain Health Group (BHG), for a randomized controlled trial (RCT; NCT03594734). The focus of the BHG was on brain health education and self-management. The objectives of this supplementary analysis are to (1) Describe compliance with the 12-month BHG; (2) Examine efficacy for improving general self-efficacy (GSE, primary) and secondary outcomes; and (3) Describe findings from the program evaluation. DESIGN: English-speaking adults (18-64 years old) who were ≥6 months post a moderate-to-severe TBI were randomized to the BHG (n = 29) or active intervention (n = 28). Data were collected at baseline and 12 months, including GSE, depression, satisfaction with life (SWL), self-rated abilities for health practices (SRAHP), and alcohol use. Program evaluation was conducted at 12 months. RESULTS: Attendance was 89%, and goal tracking was 63%. Within group analysis showed a significant increase in SRAHP scores (p = 0.018). Non-significant increases in GSE and SWL were observed, and participants perceived the BHG as helpful. No significant changes in depression or alcohol use were reported. CONCLUSION: People with TBI can engage in and benefit from the BHG and perceive the program as helpful for improving knowledge about brain health and awareness of self-management skills.

Improving transition from inpatient rehabilitation following traumatic brain injury: Protocol for the BRITE pragmatic comparative effectiveness trial.

Moderate to severe traumatic brain injury (TBI) is a common cause of long-term disability. Due to challenges that include inconsistent access to follow-up care, persons with TBI being discharged from inpatient rehabilitation facilities (IRFs) are at risk for rehospitalization, poor reintegration into the community, family stress, and other unfavorable outcomes resulting from unmet needs. In a six-center randomized pragmatic comparative effectiveness study, the BRITE trial (Brain Injury Rehabilitation: Improving the Transition Experience, ClinicalTrials.govNCT03422276), we compare the effectiveness of two existing methods for transition from IRF to community living or long-term nursing care. The Rehabilitation Discharge Plan (RDP) includes patient/family education and referrals for continued care. The Rehabilitation Transition Plan (RTP) provides RDP plus individualized, manualized care management via phone or videoconference, for 6 months. Nine hundred patients will be randomized (1:1) to RDP or RTP, with caregivers also invited to participate and contribute caregiver-reported outcomes. Extensive stakeholder input, including active participation of persons with TBI and their families, has informed all aspects of trial design and implementation planning. We hypothesize that RTP will result in better patient- and caregiver-reported outcomes (societal participation, quality of life, caregiver well-being) and more efficient use of healthcare resources at 6-months (primary outcome) and 12-months post-discharge, compared to RDP alone. Planned analyses will explore which participants benefit most from each transition model. With few exclusion criteria and other pragmatic features, the findings of this trial are expected to have a broad impact on improving transitions from inpatient TBI rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03422276.

The effect of phototherapy on sleep during acute rehabilitation after traumatic brain injury: a randomized controlled trial.

Objective: To examine the impact of bright white light (BWL) exposure on sleep quality in persons with recent traumatic brain injury (TBI).Design: Randomized, controlled device-sham studySetting: 3 TBI Model System inpatient rehabilitation unitsParticipants: 131 participants (mean 40.9 years, 68% male)Intervention: Intervention group (N = 65) received BWL (1260 lux at 20 inches, 440-480 nanometers length) for 30 minutes each morning at 12-24 inches from the face. Control group (N = 66) received red light (<450 lux, no light between 440 and 480 nanometers) for the same period. Planned intervention was maximum of 10 treatments or until discharge.Main Outcome Measure: Sleep duration and quality using actigraphic recording.Results: There were no differences found between groups on the primary outcomes nor on the secondary outcomes (sleepiness, mood, cooperation with therapy).Conclusion: BWL treatment during acute rehabilitation hospitalization does not appear to impact sleep or measures commonly associated with sleep. While studies have indicated common complaints of sleep difficulties after TBI, we were unable to document an effect for phototherapy as a treatment. With growing evidence of the effect of sleep on neural repair and cognition, further study is needed to understand the nature and treatment of sleep disorders after TBI.Clinicaltrials.gov Identifier: NCT02214212.

Predictors for 30-Day Readmissions After Traumatic Brain Injury.

OBJECTIVE: To examine predictors for 30-day readmission post-onset of traumatic brain injury (TBI) after initial trauma hospitalization. DESIGN: Retrospective cohort. PARTICIPANTS: In total, 5284 patients with an acute TBI admitted from January 1, 2006, through December 31, 2015. METHODS: Demographic and clinical data after initial TBI onset were extracted from the local trauma registry and matched with the Dallas-Fort Worth Hospital Council registry. Multiple logistic regression analysis was used to determine factors significantly associated with 30-day readmission. Top diagnosis codes for 30-day readmission were also described. RESULTS: Patients were primarily male (64.6%), non-Hispanic White (47.6%), uninsured (35.4%), and aged 46.1 ± 23.3 years. In total, 448 patients (8.5%) had a 30-day readmission. Median cumulative charges for each readmitted subject was $34 313. Factors significantly associated with 30-day readmission were falling as the cause of injury, having increased Charlson Comorbidity Index and Injury Severity Score, and discharging to a skilled nursing facility or long-term acute care. Being uninsured was associated with decreased odds of a 30-day readmission. Top diagnosis codes among the readmission visits included cardiac codes (57.7%), fluid and acid-base disorders (54.8%), and hypertension (50.1%). CONCLUSION: These data highlight those at risk for 30-day readmission across a diverse population of TBI at a large medical center. Interventions such as health literacy education or patient navigation may help mitigate 30-day readmission for at-risk patients.

123I-Iofluopane Single-Photon Emission Computed Tomography as an Imaging Biomarker of Pre-Synaptic Dopaminergic System after Moderate-to-Severe Traumatic Brain Injury.

Dopaminergic (DA) system function is frequently disrupted after traumatic brain injury (TBI). However, published interventions that target the DA system with the hope of enhancing functional outcomes are inconclusive, partially because of the lack of DA signaling biomarkers that can be used to select patients likely to benefit from DA-directed therapies or to monitor treatment efficacy. The aim of this study was to evaluate the feasibility of using 123I-iofluopane single-photon emission computerized tomography (SPECT) to assess pre-synaptic DA system dysfunction after severe TBI. Eighteen patients with severe TBI were enrolled in this study. 123I-iofluopane SPECT imaging was performed at baseline and again 2.5 h after a single dose of methylphenidate (MP) administered enterally. DA transporter (DAT) specific binding ratio (SBR) before and after MP was measured. Functional outcomes included the Disability Rating Scale, JFK Coma Recovery Scale-Revised, Functional Independence Measure, and Functional Assessment Measure. Thirteen of 18 patients completed the study. Average time from injury to SPECT scan was 48 days (standard deviation [SD], 24 days; median, 31). Baseline ioflupane striatal SBR was 1.51 ± 0.46 (median, 1.67). A 43.1% (SD, 16; median, 46.5) displacement of ioflupane from pre-synaptic DAT was observed after MP administration. Baseline SBR positively correlated with functional status at baseline and 4 weeks after completion of the study. Serum MP levels correlated with relative change in SBR (rs = 0.60; p = 0.04). Our findings suggest that 123I-iofluopane SPECT is a promising tool to determine the severity of pre-synaptic DA terminal disruption and for monitoring pharmacokinetics and pharmacodynamics of therapeutic interventions targeting the DA system.

Prevalence of 25-hydroxyvitamin D deficiency in the acute rehabilitation population following traumatic brain injury.

OBJECTIVE: To determine the prevalence of vitamin D deficiency among individuals with traumatic brain injury (TBI) undergoing acute inpatient rehabilitation. SETTING: Inpatient rehabilitation. PARTICIPANTS: Participants were admitted from November 1st, 2010 through June 30th, 2015 with diagnosis of mild-severe TBI and had serum 25 OH vitamin D levels checked upon admission. 369 out of 845 met inclusion. DESIGN: Retrospective cohort. MAIN MEASURES: 25 OH vitamin D, vitamin D treatment. RESULTS: The majority of patients were male (67%), Caucasian (89%) with private insurance (61%) and a mean age of 43.5±21.0 years. 25 OH vitamin D levels were categorized: deficient (<20 ng/mL), insufficient (20-29.9 ng/mL), and sufficient (≥30 ng/mL). There were 95 (26%) patients that were deficient, 131 (36%) that were insufficient, and 143 (39%) that were sufficient. Race/ethnicity was found to be significant (p = 0.0145) with the largest percentage of Hispanics found in the insufficient and deficient categories, and the largest percentage of Blacks in the deficient category. Most patients with deficient or insufficient vitamin D levels were prescribed vitamin D replacement during their rehab stay (p < 0.0001). CONCLUSION: The majority of patients undergoing acute inpatient rehabilitation were found to have insufficient or deficient vitamin D levels, therefore it should be routinely screened and treated as indicated.

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a healthy lifestyle program (GLB-TBI).

Weight gain is prevalent among people with traumatic brain injury (TBI) and may be attributable to environmental or injury-specific factors such as mobility impairment, endocrine dysfunction, behavioral and emotional disorders, and sensory loss. Few weight management programs exist to meet the unique needs of this population. Researchers modified a nationally recognized, evidence-based weight-loss program, Group Lifestyle Balance™ (GLB), to address the needs of over-weight and obese people post TBI (GLB-TBI). This current randomized controlled trial (RCT) examines the efficacy of the GLB-TBI on weight and secondary outcomes compared to an attention control educational support group. Furthermore, researchers have developed a mobile technology app to further engage participants in the program. This RCT will enroll and randomize 66 participants over a two-year period. It is anticipated that findings from this current RCT will contribute to the knowledge and evidence for an effective weight-loss intervention among this underserved population, with a goal of achieving full recognition by the Centers for Disease Control and Prevention-National Diabetes Prevention Program and subsequent Center for Medicare and Medicaid Services reimbursement for participation.

Phase 2 Randomized, Placebo-Controlled Clinical Trial of Recombinant Human Growth Hormone (rhGH) During Rehabilitation From Traumatic Brain Injury.

Traumatic brain injury (TBI) is a major cause of death and disability, but there are currently no therapies with proven efficacy for optimizing regeneration of repair during rehabilitation. Using standard stimulation tests, as many as 40-50% of survivors of severe TBI have deficiency of one or more pituitary hormones. Of these, the somatotropic axis is the most commonly affected, with Growth Hormone (GH) deficiency affecting ~20% of persons with severe TBI. Treatment with recombinant human Growth Hormone (rhGH) is generally effective in reversing the effects of acquired GH deficiency, but there is no evidence documenting functional or neurocognitive improvement after GH replacement in TBI patients. As a consequence, screening for GH deficiency and GH replacement when deficiency is found is not routinely performed as part of the rehabilitation of TBI survivors. Given that most of the recovery after TBI occurs within the first 6-12 months after injury and IGF-1 and GH are part of a coordinated restorative neurotrophic system, we hypothesized that patients will optimally benefit from GH therapy during the window of maximal neuroregenerative activity. We performed a Phase IIa, randomized, double-blind, placebo-controlled feasibility trial of recombinant human Growth Hormone (rhGH), starting at discharge from an inpatient rehabilitation unit, with follow up at 6 and 12 months. Our primary hypothesis was that treatment with rhGH in the subacute period would result in improved functional outcomes 6 months after injury. Our secondary hypothesis proposed that treatment with rhGH would increase IGF-1 levels and be well tolerated. Sixty-three subjects were randomized, and 40 completed the trial. At baseline, there was no correlation between IGF-1 levels and peak GH levels after L-arginine stimulation. IGF-1 levels increased after rhGH treatment, but it took longer than 1 month for levels to be higher than for placebo-treated patients. rhGH therapy was well-tolerated. The rhGH group was no different from placebo in the Disability Rating Scale, Glasgow Outcome Scale-Extended, or neuropsychological function. However, a trend toward greater improvement from baseline in Functional Independence Measure (FIM) was noted in the rhGH treated group. Future studies should include longer treatment periods, faster titration of rhGH, and larger sample sizes.

The impact of preexisting illness and substance use on functional and neuropsychological outcomes following traumatic brain injury.

Traumatic brain injury (TBI) is a significant public health problem in the US. Specific preexisting medical illnesses delay recovery after TBI and increase mortality or risk of repeat TBI. This study examined the impact of preexisting illness and substance use on patient rehabilitation outcomes following TBI. The Functional Independence Measure total score and Disability Rating Scale score measured functional outcomes at discharge from inpatient rehabilitation, while the Trail Making Test A and B and Total Trials 1-5 of the California Verbal Learning Test-II measured neuropsychological outcomes in 128 TBI survivors with moderate or severe TBI. Results showed that the presence of a heart condition or diabetes/high blood sugar was associated with lower functional outcomes by discharge. A history of a heart condition, stroke, or respiratory condition prior to TBI was associated with reduced cognitive flexibility. Those with preexisting diabetes/high blood sugar demonstrated poorer visual attention, visuomotor processing speed, and ability to learn and recall verbal information. Those with pre-TBI cancer also had greater auditory-verbal memory deficits. The findings showed that specific preexisting medical conditions are independently associated with lower functional and cognitive outcomes for patients with TBI. By screening patients for preexisting medical conditions, multidisciplinary TBI rehabilitation teams can identify patients who require more aggressive treatments or greater length of stay.

Variations in Inpatient Rehabilitation Functional Outcomes Across Centers in the Traumatic Brain Injury Model Systems Study and the Influence of Demographics and Injury Severity on Patient Outcomes.

OBJECTIVE: To compare patient functional outcomes across Traumatic Brain Injury Model Systems (TBIMS) rehabilitation centers using an enhanced statistical model and to determine factors that influence those outcomes. DESIGN: Multicenter observational cohort study. SETTING: TBIMS centers. PARTICIPANTS: Patients with traumatic brain injury (TBI) admitted to 19 TBIMS rehabilitation centers from 2003-2012 (N=5505). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Functional outcomes of patients with TBI. RESULTS: Individuals with lower functional status at the time of admission, longer duration of posttraumatic amnesia, and higher burden of medical comorbidities continued to have worse functional outcomes at discharge from inpatient rehabilitation and at the 1-year follow-up, whereas those who were employed at the time of injury had better outcomes at both time periods. Risk-adjusted patient functional outcomes for patients in most TBIMS centers were consistent with previous research. However, there were wide performance differences for a few centers even after using more recently collected data, improving on the regression models by adding predictors known to influence functional outcomes, and using bootstrapping to eliminate confounds. CONCLUSIONS: Specific patient, injury, and clinical factors are associated with differences in functional outcomes within and across TBIMS rehabilitation centers. However, these factors did not explain all the variance in patient outcomes, suggesting a role of some other predictors that remain unknown.

Suboptimal compliance with evidence-based guidelines in patients with traumatic brain injuries.

OBJECT: Evidence-based management (EBM) guidelines for severe traumatic brain injuries (TBIs) were promulgated decades ago. However, the extent of their adoption into bedside clinical practices is not known. The purpose of this study was to measure compliance with EBM guidelines for management of severe TBI and its impact on patient outcome. METHODS: This was a retrospective study of blunt TBI (11 Level I trauma centers, study period 2008-2009, n = 2056 patients). Inclusion criteria were an admission Glasgow Coma Scale score ≤ 8 and a CT scan showing TBI, excluding patients with nonsurvivable injuries-that is, head Abbreviated Injury Scale score of 6. The authors measured compliance with 6 nonoperative EBM processes (endotracheal intubation, resuscitation, correction of coagulopathy, intracranial pressure monitoring, maintaining cerebral perfusion pressure ≥ 50 cm H2O, and discharge to rehabilitation). Compliance rates were calculated for each center using multivariate regression to adjust for patient demographics, physiology, injury severity, and TBI severity. RESULTS: The overall compliance rate was 73%, and there was wide variation among centers. Only 3 centers achieved a compliance rate exceeding 80%. Risk-adjusted compliance was worse than average at 2 centers, better than average at 1, and the remainder were average. Multivariate analysis showed that increased adoption of EBM was associated with a reduced mortality rate (OR 0.88; 95% CI 0.81-0.96, p < 0.005). CONCLUSIONS: Despite widespread dissemination of EBM guidelines, patients with severe TBI continue to receive inconsistent care. Barriers to adoption of EBM need to be identified and mitigated to improve patient outcomes.

Comparative effectiveness of traumatic brain injury rehabilitation: differential outcomes across TBI model systems centers.

OBJECTIVE: To measure patient functional outcomes across rehabilitation centers. SETTING: Traumatic Brain Injury Model System (TBIMS) centers. PARTICIPANTS: Patients with traumatic brain injury (TBI) admitted to 21 TBIMS rehabilitation centers (N = 6975, during 1999-2008). DESIGN: Retrospective analysis of prospectively collected data. MAIN MEASURES: Center-specific functional outcomes of TBI patients using Functional Independence Measure, Disability Rating Scale, and Glasgow Outcome Scale-Extended. RESULTS: There were large differences in patient characteristics across centers (demographics, TBI severity, and functional deficits at admission to rehabilitation). However, even after taking those factors into account, there were significant differences in functional outcomes of patients treated at different TBIMS centers. CONCLUSION: There are significant differences in functional outcomes of TBI patients across rehabilitation centers.