Effects of Fluoxetine on Outcomes at 12 Months After Acute Stroke: Results From EFFECTS, a Randomized Controlled Trial.

Background and Purpose: The EFFECTS (Efficacy of Fluoxetine­a Randomised Controlled Trial in Stroke) recently reported that 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia at 6 months. The purpose of this predefined secondary analysis was to identify if any effects of fluoxetine were maintained or delayed over 12 months. Methods: EFFECTS was an investigator-led, randomized, placebo-controlled, double-blind, parallel group trial in Sweden that enrolled adult patients with stroke. Patients were randomized to 20 mg oral fluoxetine or matching placebo for 6 months and followed for another 6 months. The primary outcome was functional outcome (modified Rankin Scale), at 6 months. Predefined secondary outcomes for these analyses included the modified Rankin Scale, health status, quality of life, fatigue, mood, and depression at 12 months. Results: One thousand five hundred patients were recruited from 35 centers in Sweden between 2014 and 2019; 750 were allocated fluoxetine and 750 placebo. At 12 months, modified Rankin Scale data were available in 715 (95%) patients allocated fluoxetine and 712 (95%) placebo. The distribution of modified Rankin Scale categories was similar in the 2 groups (adjusted common odds ratio, 0.92 [95% CI, 0.76­1.10]). Patients allocated fluoxetine scored worse on memory with a median value of 89 (interquartile range, 75­100) versus 93 (interquartile range, 82­100); P=0.0021 and communication 93 (interquartile range, 82­100) versus 96 (interquartile range, 86­100); P=0.024 domains of the Stroke Impact Scale compared with placebo. There were no other differences in secondary outcomes. Conclusions: Fluoxetine after acute stroke had no effect on functional outcome at 12 months. Patients allocated fluoxetine scored worse on memory and communication on the Stroke Impact Scale compared with placebo, but this is likely to be due to chance. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02683213.

Recovery and Prediction of Dynamic Precision Grip Force Control After Stroke.

Background and Purpose- Dexterous object manipulation, requiring generation and control of finger forces, is often impaired after stroke. This study aimed to describe recovery of precision grip force control after stroke and to determine clinical and imaging predictors of 6-month performance. Methods- Eighty first-ever stroke patients with varying degrees of upper limb weakness were evaluated at 3 weeks, 3 months, and 6 months after stroke. Twenty-three healthy individuals of comparable age were also studied. The Strength-Dexterity test was used to quantify index finger and thumb forces during compression of springs of varying length in a precision grip. The coordination between finger forces (CorrForce), along with Dexterity-score and Repeatability-score, was calculated. Anatomical magnetic resonance imaging was used to calculate weighted corticospinal tract lesion load (wCST-LL). Results- CorrForce, Dexterity-score, and Repeatability-score in the affected hand were dramatically lower at each time point compared with the less-affected hand and the control group, even in patients with mild motor impairment according to Fugl-Meyer assessment. Improved performance over time occurred in CorrForce and Dexterity-score but not in Repeatability-score. The Fugl-Meyer assessment hand subscale, sensory function, and wCST-LL best predicted CorrForce and Dexterity-score status at 6 months (R2=0.56 and 0.87, respectively). wCST-LL explained substantial variance in CorrForce (R2=0.34) and Dexterity-score (R2=0.50) at 6 months; two-point discrimination and Fugl-Meyer score accounted for considerable additional variance. Absence of recovery in CorrForce was predicted by wCST-LL >4 cc and in Dexterity-score by wCST-LL >6 cc. Conclusions- Findings highlight persisting deficits in the ability to grasp and control finger forces after stroke. wCST-LL was the strongest predictor of performance at 6 months, but early two-point discrimination and Fugl-Meyer score had substantial additional predictive value. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT02878304.

Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke.

BACKGROUND: Spasticity after lesions of central motor pathways may be disabling and there is a need for new, cost-effective treatment methods. One novel approach is offered by the electro-dress Mollii®, primarily designed to enhance reciprocal inhibition of spastic muscles by multifocal, transcutaneous antagonist stimulation. METHODS: The Mollii® suit was set individually for 20 participants living with spasticity and hemiplegia after stroke and used in the home setting for 6 weeks. Usability and perceived effects were monitored by weekly telephone interviews. Outcome was assessed by use of the NeuroFlexor™ method for quantification of the neural component (NC) of resistance to passive stretch (spasticity), and the modified Ashworth scale (MAS) for total resistance, Fugl-Meyer Assessment of motor recovery for sensorimotor function in upper (FM-UE) and lower extremities (FM-LE), activity performance with the Action Research Arm Test (ARAT), Berg balance scale, 10 m and 6 min walk tests, and perceived functioning with the Stroke Impact Scale. RESULTS: Compliance was high (mean 19.25 of 21 sessions). Perceived positive effects were reported by 60% and most commonly related to decreased muscle tone (n = 9), improved gait pattern function (n = 7) and voluntary movement in the upper extremity (n = 6). On a group level, the NC decreased significantly in the wrist flexors of the affected hand (p = 0.023) and significant improvements according to FM-UE (p = 0.000) and FM-LE (p = 0.003) were seen after the intervention. No significant difference was detected with MAS or assessed activity performance, except for the ARAT (p = 0.000). FM-UE score change correlated significantly and fairly with the perceived effect in the upper extremity (r 0.498 p = 0.025) and in the corresponding analysis for the FM-LE and perceived effect in the lower extremity (r = 0.469 p = 0.037). CONCLUSION: This study indicates that the Mollii® method is feasible when used in the home setting to decrease spasticity and improve sensorimotor function. The results may guide a larger controlled study combined with rehabilitation interventions to enhance effects on activity and participation domains. TRIAL REGISTRATION: NCT04076878 . Registered 2 September 2019 - Retrospectively registered.

The effect of time on cognitive impairments after non-traumatic subarachnoid haemorrhage and after traumatic brain injury.

OBJECTIVES: To compare the effect of time on cognitive impairments after Subarachnoid Haemorrhage and Traumatic Brain Injury and explore associations with baseline variables and global function. METHODS: Patients with a Glasgow Coma Scale score of 3-13, were assessed at 3, 6 and 12 months post injury by use of BNIS for cognitive impairment, RLAS-R to categorise cognitive and behavioural function, Barthel Index to assess performance of daily living, HADS to screen for depression and anxiety, and EuroQoL-5D, LiSat-11 and Glasgow Outcome Scale Extended to assess global function. RESULTS: BNIS T-scores did not differ significantly between groups and the proportion of patients with cognitive impairments was not significantly different at any time point. Cognition improved significantly between all time points in both groups except from 6 to 12 months after TBI. Generalised estimating equation showed non-significant signs of slower recovery of BNIS T-scores over time after SAH. Acute GCS scores were associated with BNIS T-scores after TBI but not after SAH. At 12 months, similar proportions of patients with SAH and TBI had good outcome. CONCLUSIONS: Cognitive improvements after SAH and TBI exhibit similarities and correlate with global function. GCS scores are associated with outcome after TBI but not after SAH.

Normative NeuroFlexor data for detection of spasticity after stroke: a cross-sectional study.

BACKGROUND AND OBJECTIVE: The NeuroFlexor is a novel instrument for quantification of neural, viscous and elastic components of passive movement resistance. The aim of this study was to provide normative data and cut-off values from healthy subjects and to use these to explore signs of spasticity at the wrist and fingers in patients recovering from stroke. METHODS: 107 healthy subjects (age range 28-68 years; 51 % females) and 39 stroke patients (age range 33-69 years; 33 % females), 2-4 weeks after stroke, were assessed with the NeuroFlexor. Cut-off values based on mean + 3SD of the reference data were calculated. In patients, the modified Ashworth scale (MAS) was also applied. RESULTS: In healthy subjects, neural component was 0.8 ± 0.9 N (mean ± SD), elastic component was 2.7 ± 1.1 N, viscous component was 0.3 ± 0.3 N and resting tension was 5.9 ± 1 N. Age only correlated with elastic component (r = -0.3, p = 0.01). Elasticity and resting tension were higher in males compared to females (p = 0.001) and both correlated positively with height (p = 0.01). Values above healthy population cut-off were observed in 16 patients (41 %) for neural component, in 2 (5 %) for elastic component and in 23 (59 %) for viscous component. Neural component above cut-off did not correspond well to MAS ratings. Ten patients with MAS = 0 had neural component values above cut-off and five patients with MAS ≥ 1 had neural component within normal range. CONCLUSION: This study provides NeuroFlexor cut-off values that are useful for detection of spasticity in the early phase after stroke.

Associations between care pathways and outcome 1 year after severe traumatic brain injury.

OBJECTIVE: To assess associations between real-world care pathways for working-age patients in the first year after severe traumatic brain injury and outcomes at 1 year. SETTING AND DESIGN: Prospective, observational study with recruitment from 6 neurosurgical centers in Sweden and Iceland. Follow-up to 1 year, independently of care pathways, by rehabilitation physicians and paramedical professionals. PARTICIPANTS: Patients with severe traumatic brain injury, lowest (nonsedated) Glasgow Coma Scale score 3 to 8 during the first 24 hours and requiring neurosurgical intensive care, age 18 to 65 years, and alive 3 weeks after injury. MAIN MEASURES: Length of stay in intensive care, time between intensive care discharge and rehabilitation admission, outcome at 1 year (Glasgow Outcome Scale Extended score), acute markers of injury severity, preexisting medical conditions, and post-acute complications. Logistic regression analyses were performed. RESULTS: A multivariate model found variables significantly associated with outcome (odds ratio for good outcome [confidence interval], P value) to be as follows: length of stay in intensive care (0.92 [0.87-0.98], 0.014), time between intensive care discharge and admission to inpatient rehabilitation (0.97 [0.94-0.99], 0.017), and post-acute complications (0.058 [0.006-0.60], 0.017). CONCLUSIONS: Delays in rehabilitation admission were negatively associated with outcome. Measures to ensure timely rehabilitation admission may improve outcome. Further research is needed to evaluate possible causation.

Introduction to the findings of the International Collaboration on Mild Traumatic Brain Injury Prognosis: what is a prognostic study?

Prognostic studies of mild traumatic brain injury (MTBI) can serve many purposes. First, they are used to describe paths and outcomes of patients with MTBI. Second, they provide information on which characteristics are associated with the occurrence of outcomes. Third, they provide insight into the causation of poor or favorable course of the disease. Finally, they can assess how differences in the probability of outcomes can help predict the course of patients. In this article, we summarize methodologic principles used by the International Collaboration on MTBI Prognosis to appraise the prognostic literature. Differentiating prognostic factors (causally linked with outcome), prognostic markers (associated but not causally), and predictors is important to guide interventions, public health policy, and research. Ideally, prognostic studies need a clear statement of the type of question (hypothesis-generating descriptive, exploration of possible prognostic variables, confirmatory modeling of prognosis); a cohort study design with standardized follow-up of a representative population of patients with MTBI; a standardized data collection using reliable and accurate tools to capture clinically, biologically, psychologically, or socially relevant variables and outcomes; and an analysis of data based on survival methods. Interpretation of prognostic studies should consider biases related to differential inclusion of nonrepresentative samples of patients, poor measurements of outcomes, and poor control for confounders. Transferring prognostic results into clinical practice should be based on estimates of the predictive performance of models and on a demonstration that patient outcomes can be improved by the use of prediction rules.

Systematic review of the risk of Parkinson's disease after mild traumatic brain injury: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

OBJECTIVE: To synthesize the best available evidence on the risk of Parkinson's disease (PD) after mild traumatic brain injury (MTBI). DATA SOURCES: MEDLINE and other databases were searched (1990-2012) with terms including "craniocerebral trauma" and "parkinsonian disorders." Reference lists of eligible articles and relevant systematic reviews and meta-analyses were also searched. STUDY SELECTION: Controlled clinical trials, cohort studies, and case-control studies were selected according to predefined criteria. Studies had to have a minimum of 30 concussion cases. DATA EXTRACTION: Eligible studies were critically appraised using a modification of the Scottish Intercollegiate Guidelines Network criteria. Two reviewers independently reviewed and extracted data from accepted studies into evidence tables. DATA SYNTHESIS: Evidence was synthesized qualitatively according to modified Scottish Intercollegiate Guidelines Network criteria. Sixty-five studies were eligible and reviewed, and 5 of these with a low risk of bias were accepted as scientifically admissible and form the basis of our findings. Among these admissible studies, the definitions of MTBI were highly heterogeneous. One study found a significant positive association between MTBI and PD (odds ratio, 1.5; 95% confidence interval, 1.4-1.7). The estimated odds ratio decreased with increasing latency between MTBI and PD diagnosis, which suggests reverse causality. The other 4 studies did not find a significant association. CONCLUSIONS: The best available evidence argues against an important causal association between MTBI and PD. There are few high-quality studies on this topic. Prospective studies of long duration would address the limitations of recall of head injury and the possibility of reverse causation.

Nonsurgical interventions after mild traumatic brain injury: a systematic review. Results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

OBJECTIVE: To synthesize the best available evidence regarding the impact of nonsurgical interventions on persistent symptoms after mild traumatic brain injury (MTBI). DATA SOURCES: MEDLINE and other databases were searched (2001-2012) with terms including "rehabilitation." Inclusion criteria were original, peer-reviewed research published in English and other languages. References were also identified from the bibliographies of eligible articles. STUDY SELECTION: Controlled trials and cohort and case-control studies were selected according to predefined criteria. Studies had to have a minimum of 30 MTBI cases and assess nonsurgical interventions using clinically relevant outcomes such as self-rated recovery. DATA EXTRACTION: Eligible studies were critically appraised using a modification of the Scottish Intercollegiate Guidelines Network (SIGN) criteria. Two reviewers independently reviewed each study and extracted data from the admissible studies into evidence tables. DATA SYNTHESIS: The evidence was synthesized qualitatively according to the modified SIGN criteria. Recommendations were linked to the evidence tables using a best-evidence synthesis. After 77,914 records were screened, only 2 of 7 studies related to nonsurgical interventions were found to have a low risk of bias. One studied the effect of a scheduled telephone intervention offering counseling and education on outcome and found a significantly better outcome for symptoms (6.6 difference in adjusted mean symptom score; 95% confidence interval, 1.2-12.0), but no difference in general health outcome at 6 months after MTBI. The other was a randomized controlled trial of the effectiveness of 6 days of bed rest on posttraumatic complaints 6 months postinjury, compared with no bed rest, and found no effect. CONCLUSIONS: Some evidence suggests that early, reassuring educational information is beneficial after MTBI. Well-designed intervention studies are required to develop effective treatments and improve outcomes for adults and children at risk for persistent symptoms after MTBI.

Systematic review of self-reported prognosis in adults after mild traumatic brain injury: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

OBJECTIVE: To update the mild traumatic brain injury (MTBI) prognosis review published by the World Health Organization Task Force in 2004. DATA SOURCES: MEDLINE, PsycINFO, Embase, CINAHL, and SPORTDiscus were searched from 2001 to 2012. We included published, peer-reviewed studies with more than 30 adult cases. STUDY SELECTION: Controlled trials and cohort and case-control studies were selected according to predefined criteria. Studies had to assess subjective, self-reported outcomes. After 77,914 titles and abstracts were screened, 299 articles were eligible and reviewed for scientific quality. This includes 3 original International Collaboration on MTBI Prognosis (ICoMP) research studies. DATA EXTRACTION: Eligible studies were critically appraised using the Scottish Intercollegiate Guidelines Network criteria. Two reviewers independently reviewed each study and tabled data from accepted articles. A third reviewer was consulted for disagreements. DATA SYNTHESIS: Evidence from accepted studies was synthesized qualitatively into key findings, and prognostic information was prioritized according to design as exploratory or confirmatory. Of 299 reviewed studies, 101 (34%) were accepted and form our evidence base of prognostic studies. Of these, 23 addressed self-reported outcomes in adults, including 2 of the 3 original ICoMP research studies. These studies show that common postconcussion symptoms are not specific to MTBI/concussion and occur after other injuries as well. Poor recovery after MTBI is associated with poorer premorbid mental and physical health status and with more injury-related stress. Most recover over 1 year, but persistent symptoms are more likely in those with more acute symptoms and more emotional stress. CONCLUSIONS: Common subjective symptoms after MTBI are not necessarily caused by brain injury per se, but they can be persistent in some patients. Those with more initial complaints and psychological distress recover slower. We need more high-quality research on these issues.

Systematic review of the prognosis after mild traumatic brain injury in adults: cognitive, psychiatric, and mortality outcomes: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

OBJECTIVE: To synthesize the best available evidence on objective outcomes after adult mild traumatic brain injury (MTBI). DATA SOURCES: MEDLINE and other databases were searched (2001-2012) for studies related to MTBI. Inclusion criteria included published, peer-reviewed articles in English and other languages. References were also identified from the bibliographies of eligible articles. STUDY SELECTION: Randomized controlled trials and cohort and case-control studies were selected according to predefined criteria. Studies had to have a minimum of 30 MTBI cases and assess objective outcomes in adults. DATA EXTRACTION: Eligible studies were critically appraised using a modification of the Scottish Intercollegiate Guidelines Network (SIGN) criteria. Two reviewers independently reviewed each study and extracted data from accepted articles into evidence tables. DATA SYNTHESIS: Evidence was synthesized qualitatively according to modified SIGN criteria, and studies were categorized as exploratory or confirmatory based on the strength of their design and evidence. After 77,914 records were screened, 299 were found to be relevant and critically reviewed, and 101 were deemed scientifically admissible. Of these, 21 studies that were related to the objective outcomes form the basis of this review. Most evidence indicates the presence of cognitive deficits in the first 2 weeks post-MTBI, and some evidence suggests that complete recovery may take 6 months or a year. A small number of studies indicate that MTBI increases the risk of psychiatric illnesses and suicide. CONCLUSIONS: Early cognitive deficits are common, and complete recovery may be prolonged. Conclusions about mortality post-MTBI are limited. This review has implications for expected recovery after MTBI and MTBI-related health sequelae. Well-designed confirmatory studies are needed to understand the medium- to long-term consequences of MTBI and to further evaluate the effect of prior MTBI and injury severity on recovery.

Systematic review of return to work after mild traumatic brain injury: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

OBJECTIVE: To synthesize the best available evidence on return to work (RTW) after mild traumatic brain injury (MTBI). DATA SOURCES: MEDLINE and other databases were searched (2001-2012) with terms including "craniocerebral trauma" and "employment." Reference lists of eligible articles were also searched. STUDY SELECTION: Controlled trials and cohort and case-control studies were selected according to predefined criteria. Studies had to assess RTW or employment outcomes in at least 30 MTBI cases. DATA EXTRACTION: Eligible studies were critically appraised using a modification of the Scottish Intercollegiate Guidelines Network criteria. Two reviewers independently reviewed and extracted data from accepted studies into evidence tables. DATA SYNTHESIS: Evidence was synthesized qualitatively according to modified Scottish Intercollegiate Guidelines Network criteria and prioritized according to design as exploratory or confirmatory. After 77,914 records were screened, 299 articles were found eligible and reviewed; 101 (34%) of these with a low risk of bias were accepted as scientifically admissible, and 4 of these had RTW or employment outcomes. This evidence is preliminary and suggests that most workers RTW within 3 to 6 months after MTBI; MTBI is not a significant risk factor for long-term work disability; and predictors of delayed RTW include a lower level of education (<11y of formal education), nausea or vomiting on hospital admission, extracranial injuries, severe head/bodily pain early after injury, and limited job independence and decision-making latitude. CONCLUSIONS: Our findings are based on preliminary evidence with varied patient characteristics and MTBI definitions, thus limiting firm conclusions. More well-designed studies are required to understand RTW and sustained employment after MTBI in the longer term (≥2y post-MTBI).

Systematic review of prognosis and return to play after sport concussion: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

OBJECTIVE: To synthesize the best available evidence on prognosis after sport concussion. DATA SOURCES: MEDLINE and other databases were searched (2001-2012) with terms including "craniocerebral trauma" and "sports." Reference lists of eligible articles were also searched. STUDY SELECTION: Randomized controlled trials and cohort and case-control studies were selected according to predefined criteria. Studies had to have a minimum of 30 concussion cases. DATA EXTRACTION: Eligible studies were critically appraised using a modification of the Scottish Intercollegiate Guidelines Network (SIGN) criteria. Two reviewers independently reviewed and extracted data from accepted studies into evidence tables. DATA SYNTHESIS: Evidence was synthesized qualitatively according to modified SIGN criteria, and studies were categorized as exploratory or confirmatory based on the strength of their design and evidence. After 77,914 records were screened, 52 articles were eligible for this review, and 24 articles (representing 19 studies) with a low risk of bias were accepted. Our findings are based on exploratory studies of predominantly male football players at the high school, collegiate, and professional levels. Most athletes recover within days to a few weeks, and American and Australian professional football players return to play quickly after mild traumatic brain injury. Delayed recovery appears more likely in high school athletes, in those with a history of previous concussion, and in those with a higher number and duration of postconcussion symptoms. CONCLUSIONS: The evidence concerning sports concussion course and prognosis is very preliminary, and there is no evidence on the effect of return-to-play guidelines on prognosis. Our findings have implications for further research. Well-designed, confirmatory studies are urgently needed to understand the consequences of sport concussion, including recurrent concussion, across different athletic populations and sports.

Methodological issues and research recommendations for prognosis after mild traumatic brain injury: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

The International Collaboration on Mild Traumatic Brain Injury (MTBI) Prognosis performed a comprehensive search and critical review of the literature from 2001 to 2012 to update the 2002 best-evidence synthesis conducted by the World Health Organization Collaborating Centre for Neurotrauma, Prevention, Management and Rehabilitation Task Force on the prognosis of MTBI. Of 299 relevant studies, 101 were accepted as scientifically admissible. The methodological quality of the research literature on MTBI prognosis has not improved since the 2002 Task Force report. There are still many methodological concerns and knowledge gaps in the literature. Here we report and make recommendations on how to avoid methodological flaws found in prognostic studies of MTBI. Additionally, we discuss issues of MTBI definition and identify topic areas in need of further research to advance the understanding of prognosis after MTBI. Priority research areas include but are not limited to the use of confirmatory designs, studies of measurement validity, focus on the elderly, attention to litigation/compensation issues, the development of validated clinical prediction rules, the use of MTBI populations other than hospital admissions, continued research on the effects of repeated concussions, longer follow-up times with more measurement periods in longitudinal studies, an assessment of the differences between adults and children, and an account for reverse causality and differential recall bias. Well-conducted studies in these areas will aid our understanding of MTBI prognosis and assist clinicians in educating and treating their patients with MTBI.

Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility.

BACKGROUND: Intensive task specific training early after stroke may enhance beneficial neuroplasticity and functional recovery. Impaired gait after hemiparetic stroke remains a challenge that may be approached early after stroke by use of novel technology. The aim of the study was to investigate the safety and feasibility of the exoskeleton Hybrid Assistive Limb (HAL) for intensive gait training as part of a regular inpatient rehabilitation program for hemiparetic patients with severely impaired gait early after stroke. METHODS: Eligible were patients until 7 weeks after hemiparetic stroke. Training with HAL was performed 5 days per week by the autonomous and/or the voluntary control mode offered by the system. The study protocol covered safety and feasibility issues and aspects on motor function, gait performance according to the 10 Meter Walking Test (10MWT) and Functional Ambulation Categories (FAC), and activity performance. RESULTS: Eight patients completed the study. Median time from stroke to inclusion was 35 days (range 6 to 46). Training started by use of the autonomous HAL mode in all and later switched to the voluntary mode in all but one and required one or two physiotherapists. Number of training sessions ranged from 6 to 31 (median 17) and walking time per session was around 25 minutes. The training was well tolerated and no serious adverse events occurred. All patients improved their walking ability during the training period, as reflected by the 10MWT (from 111.5 to 40 seconds in median) and the FAC (from 0 to 1.5 score in median). CONCLUSIONS: The HAL system enables intensive training of gait in hemiparetic patients with severely impaired gait function early after stroke. The system is safe when used as part of an inpatient rehabilitation program for these patients by experienced physiotherapists.

Effects of different exercise protocols on aerobic capacity, blood pressure, biochemical parameters, and body weight in chronic stroke survivors: a randomized controlled trial.

OBJECTIVE: To explore the impact on risk factors for recurrent stroke after gait training among persons restricted in walking in the chronic phase after stroke. METHODS: In this randomized controlled trial, two groups performed gait training, 1 session/day, 3 days/week for 6 weeks, including electromechanically assisted gait training on a treadmill (EAGT) (n=12) or variable conventional gait training only (n=15); a control group (n=11) continued as usual. Endurance assessed with the 6-minute walk test, blood pressure, weight and blood samples were collected at baseline and after 6 weeks. Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in plasma, and HbA1c in blood (reflecting glucose levels) were analysed. RESULTS: The EAGT group walked more than twice the distance compared to the Conventional training group while the effective training time was similar. Endurance in walking increased most in the Conventional group while the Control group declined. Systolic blood pressure decreased most in the Conventional group, with a moderate effect size (ŋp2) of 0.0921 (95% confidence interval (CI)0.0012-0.2598). Body weight decreased most in the EAGT group with a large effect size (ŋp2) of 0.1406 (95% CI0.0047-0.3452). Lipid levels exhibited non-conclusive changes and HbA1c did not change significantly in any group. CONCLUSIONS: Results indicate that six weeks of gait training may change risk factors for recurrent stroke even in persons restricted in mobility and that different training methods may have differential effects. These findings are in agreement with previous studies in less severely disabled persons and should encourage further studies in the current subgroup.

Early intervention for patients at risk for persisting disability after mild traumatic brain injury: a randomized, controlled study.

STUDY OBJECTIVE: To investigate the effect of an early intervention visit in addition to written information and treatment as usual for patients with an estimated high risk for persisting disability after a mild traumatic brain injury (MTBI). RESEARCH DESIGN: Randomized controlled trial. METHODS: One hundred and seventy-three patients, aged 15-70 years with a Glasgow coma scale of 14-15 were included. All received written information about MTBI. Ninety-seven patients who reported three or more symptoms according to the rivermead post-concussion symptoms questionnaire (RPQ) at 10 days after the injury were considered as high-risk patients and were randomized to either early visit to a doctor or to treatment as usual (TAU); all patients including the 76 low-risk patients were followed-up at 3 months. Completion rate was 83%. Outcome measures included RPQ and the hospital anxiety and depression scale. RESULTS: RPQ symptoms decreased significantly in both randomized groups, but were not significantly different in the groups at 3 months. At 3 months, anxiety and depression scores did not differ between groups. CONCLUSIONS: An early intervention, offered to patients with an estimated high risk for persisting disability, had no additional effect on symptom level at 3 months after MTBI as compared to TAU.

The impact of visuospatial and executive function on activity performance and outcome after robotic or conventional gait training, long-term after stroke-as part of a randomized controlled trial.

INTRODUCTION: Visuospatial and executive impairments have been associated with poor activity performance sub-acute after stroke. Potential associations long-term and in relation to outcome of rehabilitation interventions need further exploration. AIMS: To explore associations between visuospatial and executive function and 1) activity performance (mobility, self-care and domestic life) and 2) outcome after 6 weeks of conventional gait training and/or robotic gait training, long term (1-10 years) after stroke. METHODS: Participants (n = 45), living with stroke affecting walking ability and who could perform the items assessing visuospatial/executive function included in the Montreal Cognitive Assessment (MoCA Vis/Ex) were included as part of a randomized controlled trial. Executive function was evaluated using ratings by significant others according to the Dysexecutive Questionnaire (DEX); activity performance using 6-minute walk test (6MWT), 10-meter walk test (10MWT), Berg balance scale, Functional Ambulation Categories, Barthel Index and Stroke Impact Scale. RESULTS: MoCA Vis/Ex was significantly associated with baseline activity performance, long-term after stroke (r = .34-.69, p < .05). In the conventional gait training group, MoCA Vis/Ex explained 34% of the variance in 6MWT after the six-week intervention (p = 0.017) and 31% (p = 0.032) at the 6 month follow up, which indicate that a higher MoCA Vis/Ex score enhanced the improvement. The robotic gait training group presented no significant associations between MoCA Vis/Ex and 6MWT indicating that visuospatial/executive function did not affect outcome. Rated executive function (DEX) presented no significant associations to activity performance or outcome after gait training. CONCLUSION: Visuospatial/executive function may significantly affect activity performance and the outcome of rehabilitation interventions for impaired mobility long-term after stroke and should be considered in the planning of such interventions. Patients with severely impaired visuospatial/executive function may benefit from robotic gait training since improvement was seen irrespective of visuospatial/executive function. These results may guide future larger studies on interventions targeting long-term walking ability and activity performance. TRIAL REGISTRATION: clinicaltrials.gov (NCT02545088) August 24, 2015.

Gait pattern after electromechanically-assisted gait training with the Hybrid Assistive Limb and conventional gait training in sub-acute stroke rehabilitation-A subsample from a randomized controlled trial.

Introduction: Electromechanically-assisted gait training has been introduced in stroke rehabilitation as a means to enable gait training with a large number of reproducible and symmetrical task repetitions, i.e. steps. However, few studies have evaluated its impact on gait pattern functions. This study includes persons with no independent ambulation function at the start of a 4-week neurorehabilitation period in the sub-acute phase after stroke. The primary aim of the study was to evaluate whether the addition of electromechanically-assisted gait training to conventional training resulted in better gait pattern function than conventional training alone. The secondary aim was to identify correlations between overall gait quality and standardized clinical assessments. Participants and methods: Seventeen patients with no independent ambulation function who participated in a Prospective Randomized Open Blinded End-point study in the sub-acute phase after stroke were randomized into two groups; one group (n = 7) to undergo conventional training only (CONV group) and the other group (n = 10) to undergo conventional training with additional electromechanically-assisted gait training (HAL group). All patients were assessed with 3D gait analysis and clinical assessments after the 4-week intervention period. Overall gait quality as per the Gait Profile Score (GPS), as well as kinematic, and kinetic and other spatiotemporal metrics were collected and compared between intervention groups. Correlations between biomechanical and clinical outcomes were evaluated. Results: Both the CONV and HAL groups exhibited similar gait patterns with no significant differences between groups in any kinematic, kinetic parameters or other spatiotemporal metrics. The GPS for the paretic limb had a median (IQR) of 12.9° (7.8°) and 13.4° (4.3°) for the CONV and HAL groups, respectively (p = 0.887). Overall gait quality was correlated with independence in walking, walking speed, movement function and balance. We found no added benefit in gait pattern function from the electromechanically-assisted gait training compared to the conventional training alone. Discussion: This finding raises new questions about how to best design effective and optimal post-stroke rehabilitation programs in patients with moderate to severe gait impairments to achieve both independent walking and optimal gait pattern function, and about which patients should be in focus in further studies on the efficacy of electromechanically-assisted gait training. Clinical trial registration: The study was retrospectively registered at ClinicalTrials.gov, identifier (NCT02410915) on April 2015.

Validity, Intra-Rater Reliability and Normative Data of the Neuroflexor™ Device to Measure Spasticity of the Ankle Plantar Flexors after Stroke.

OBJECTIVE: Quantification of lower limb spasticity after stroke and the differentiation of neural from passive muscle resistance remain key clinical challenges. The aim of this study was to validate the novel NeuroFlexor foot module, to assess the intrarater reliability of measurements and to identify normative cut-off values. METHODS: Fifteen patients with chronic stroke with clinical history of spasticity and 18 healthy subjects were examined with the NeuroFlexor foot module at controlled velocities. Elastic, viscous and neural components of passive dorsiflexion resistance were quantified (in Newton, N). The neural component, reflecting stretch reflex mediated resistance, was validated against electromyography activity. A test-retest design with a 2-way random effects model permitted study of intra-rater reliability. Finally, data from 73 healthy subjects were used to establish cutoff values according to mean + 3 standard deviations and receiver operating characteristic curve analysis. RESULTS: The neural component was higher in stroke patients, increased with stretch velocity and correlated with electromyography amplitude. Reliability was high for the neural component (intraclass correlation coefficient model 2.1 (ICC2,1) ≥ 0.903) and good for the elastic component (ICC2,1 ≥ 0.898). Cutoff values were identified, and all patients with neural component above the limit presented pathological electromyography amplitude (area under the curve (AUC) = 1.00, sensitivity = 100%, specificity = 100%). CONCLUSION: The NeuroFlexor may offer a clinically feasible and non-invasive way to objectively quantify lower limb spasticity.