Can telerehabilitation services combined with caregiver-mediated exercises improve early supported discharge services poststroke? A study protocol for a multicentre, observer-blinded, randomized controlled trial.

BACKGROUND: Recovery of walking ability is an important goal for patients poststroke, and a basic level of mobility is critical for an early discharge home. Caregiver-mediated exercises could be a resource-efficient strategy to augment exercise therapy and improve mobility in the first months poststroke. A combination of telerehabilitation and face-to-face support, blended care, may empower patient-caregiver dyads and smoothen the transition from professional support to self-management. The Armed4Stroke study aims to investigate the effects of a caregiver-mediated exercise program using a blended care approach in addition to usual care, on recovery of mobility in the first 6 months poststroke. METHODS: A multicentre, observer-blinded randomized clinical trial in which 74 patient-caregiver dyads will be enrolled in the first 3 months poststroke. Dyads are randomly allocated to a caregiver-mediated exercises intervention or to a control group. The primary endpoint is the self-reported mobility domain of the Stroke Impact Scale. Secondary endpoints include care transition preparedness and psychological functioning of dyads, length of inpatient stay, gait-related measures and extended ADL of patients, and caregiver burden. Outcomes are assessed at enrolment, end of treatment and 6 months follow-up. RESULTS: During 8 weeks, caregivers are trained to become an exercise coach using a blended care approach. Dyads will receive a tailor-made, progressive training program containing task-specific exercises focusing on gait, balance, physical activity and outdoor activities. Dyads are asked to perform the training program a minimum of 5 times a week for 30 min per session, supported by a web-based telerehabilitation system with instruction videos and a messaging environment to communicate with their physiotherapist. CONCLUSIONS: We hypothesize that the Armed4Stroke program will increase self-reported mobility and independence in ADL, facilitating an early discharge poststroke. In addition, we hypothesize that active involvement of caregivers and providing support using blended care, will improve the care transition when professional support tapers off. Therefore, the Armed4Stroke program may complement early supported discharge services. TRIAL REGISTRATION: Netherlands Trial Register, NL7422 . Registered 11 December 2018.

Predicting Upper Limb Motor Impairment Recovery after Stroke: A Mixture Model.

OBJECTIVE: Spontaneous recovery is an important determinant of upper extremity recovery after stroke and has been described by the 70% proportional recovery rule for the Fugl-Meyer motor upper extremity (FM-UE) scale. However, this rule is criticized for overestimating the predictability of FM-UE recovery. Our objectives were to develop a longitudinal mixture model of FM-UE recovery, identify FM-UE recovery subgroups, and internally validate the model predictions. METHODS: We developed an exponential recovery function with the following parameters: subgroup assignment probability, proportional recovery coefficient r k , time constant in weeks τ k , and distribution of the initial FM-UE scores. We fitted the model to FM-UE measurements of 412 first-ever ischemic stroke patients and cross-validated endpoint predictions and FM-UE recovery cluster assignment. RESULTS: The model distinguished 5 subgroups with different recovery parameters ( r1 = 0.09, τ1 = 5.3, r2 = 0.46, τ2 = 10.1, r3 = 0.86, τ3 = 9.8, r4 = 0.89, τ4 = 2.7, r5 = 0.93, τ5 = 1.2). Endpoint FM-UE was predicted with a median absolute error of 4.8 (interquartile range [IQR] = 1.3-12.8) at 1 week poststroke and 4.2 (IQR = 1.3-9.8) at 2 weeks. Overall accuracy of assignment to the poor (subgroup 1), moderate (subgroups 2 and 3), and good (subgroups 4 and 5) FM-UE recovery clusters was 0.79 (95% equal-tailed interval [ETI] = 0.78-0.80) at 1 week poststroke and 0.81 (95% ETI = 0.80-0.82) at 2 weeks. INTERPRETATION: FM-UE recovery reflects different subgroups, each with its own recovery profile. Cross-validation indicates that FM-UE endpoints and FM-UE recovery clusters can be well predicted. Results will contribute to the understanding of upper limb recovery patterns in the first 6 months after stroke. ANN NEUROL 2020;87:383-393 Ann Neurol 2020;87:383-393.

Computerised patient-specific prediction of the recovery profile of upper limb capacity within stroke services: the next step.

INTRODUCTION: Predicting upper limb capacity recovery is important to set treatment goals, select therapies and plan discharge. We introduce a prediction model of the patient-specific profile of upper limb capacity recovery up to 6 months poststroke by incorporating all serially assessed clinical information from patients. METHODS: Model input was recovery profile of 450 patients with a first-ever ischaemic hemispheric stroke measured using the Action Research Arm Test (ARAT). Subjects received at least three assessment sessions, starting within the first week until 6 months poststroke. We developed mixed-effects models that are able to deal with one or multiple measurements per subject, measured at non-fixed time points. The prediction accuracy of the different models was established by a fivefold cross-validation procedure. RESULTS: A model with only ARAT time course, finger extension and shoulder abduction performed as good as models with more covariates. For the final model, cross-validation prediction errors at 6 months poststroke decreased as the number of measurements per subject increased, from a median error of 8.4 points on the ARAT (Q1-Q3:1.7-28.1) when one measurement early poststroke was used, to 2.3 (Q1-Q3:1-7.2) for seven measurements. An online version of the recovery model was developed that can be linked to data acquisition environments. CONCLUSION: Our innovative dynamic model can predict real-time, patient-specific upper limb capacity recovery profiles up to 6 months poststroke. The model can use all available serially assessed data in a flexible way, creating a prediction at any desired moment poststroke, stand-alone or linked with an electronic health record system.

Agreement and differences regarding family functioning between patients with acquired brain injury and their partners.

PRIMARY OBJECTIVE: To investigate the level of agreement and differences regarding the perception of family functioning between patients with acquired brain injury and their partners. Our hypothesis was that patients would report better family functioning than their partners. RESEARCH DESIGN: Cross-sectional studyMethods and Procedures: Baseline data were used from 77 patient-partner dyads (87.0% stroke) who were participating in the ongoing CARE4Patient and CARE4Carer trials. Family functioning was assessed using the General Functioning subscale of the McMaster Family Assessment Device (FAD-GF). Agreement was assessed with intraclass correlation coefficient, a Bland-Altman plot, percentages absolute agreement and weighted kappa values. Differences were tested with Wilcoxon signed-rank tests. MAIN OUTCOMES AND RESULTS: Patients and their partners differed in their perception of family functioning. Within-dyad agreement was poor regarding the overall FAD-GF scores with partners reporting significantly poorer family functioning compared to the patients (32.5% versus 18.2%). Agreement regarding the individual items ranged from slight to moderate. CONCLUSIONS: Health care professionals should assess family functioning after stroke in both patients and their partners, and any discrepancies should be discussed with both members of the patient-partner dyad.

Prospectively Classifying Community Walkers After Stroke: Who Are They?

OBJECTIVE: To classify patients with stroke into subgroups based on their characteristics at the moment of discharge from inpatient rehabilitation in order to predict community ambulation outcome 6 months later. DESIGN: Prospective cohort study with a baseline measurement at discharge from inpatient care and final outcome determined after 6 months. SETTING: Community. PARTICIPANTS: A cohort of patients (N=243) with stroke, referred for outpatient physical therapy, after completing inpatient rehabilitation in The Netherlands. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A classification model was developed using Classification And Regression Tree (CART) analysis. Final outcome was determined using the community ambulation questionnaire. Potential baseline predictors included patient demographics, stroke characteristics, use of assistive devices, comfortable gait speed, balance, strength, motivation, falls efficacy, anxiety, and depression. RESULTS: The CART model accurately predicted independent community ambulation in 181 of 193 patients with stroke, based on a comfortable gait speed at discharge of 0.5 meters per second or faster. In contrast, 27 of 50 patients with gait speeds below 0.5 meters per second were correctly predicted to become noncommunity walkers. CONCLUSIONS: We show that comfortable gait speed is a key factor in the prognosis of community ambulation outcome. The CART model may support clinicians in organizing community services at the moment of discharge from inpatient care.

Effects of intensive neuropsychological rehabilitation for acquired brain injury.

The objective of the study was to examine the effects of a comprehensive neuropsychological rehabilitation programme (Intensive NeuroRehabilitation, INR) on the emotional and behavioural consequences of acquired brain injury (ABI). The participants were 75 adult patients suffering from ABI (33 traumatic brain injury, 14 stroke, 10 tumour, 6 hypoxia, 12 other), all of whom were admitted to the INR treatment programme. The main outcome measures were: general psychological well-being (Symptom-Checklist-90), depression and anxiety (Beck Depression Inventory-II, Hospital Anxiety and Depression Scale, State Trait Anxiety Inventory), and quality of life (Quality of Life in Brain Injury). The study was a non-blinded, waiting-list controlled trial. During the waiting-list period no or minimal care was provided. Multivariate analysis of the main outcome measures showed large effect sizes for psychological well-being (partial η2 = .191, p < .001), depression (partial η2 = .168, p < .001), and anxiety (partial η2 = .182, p < .001), and a moderate effect size for quality of life (partial η2 = .130, p = .001). Changes on neuropsychological tests did not differ between the groups. It was concluded that the INR programme improved general psychological well-being, depressive symptoms, anxiety, and quality of life. The programme does not affect cognitive functioning.

Caregiver-mediated exercises with e-health support for early supported discharge after stroke (CARE4STROKE): study protocol for a randomized controlled trial.

BACKGROUND: Several systematic reviews have shown that additional exercise therapy has a positive effect on functional outcome after stroke. However, there is an urgent need for resource-efficient methods to augment rehabilitation services without increasing health care costs. Asking informal caregivers to do exercises with their loved ones, combined with e-health services may be a cost-effective method to promote early supported discharge with increased functional outcome. The primary aim of the CARE4STROKE study is to evaluate the effects and cost-effectiveness of a caregiver-mediated exercises program combined with e-health services after stroke in terms of self-reported mobility and length of stay. METHODS: An observer-blinded randomized controlled trial, in which 66 stroke-patients admitted to a hospital stroke unit, rehabilitation center or nursing home are randomly assigned to either 8 weeks of the CARE4STROKE program in addition to usual care (i.e., experimental group) or 8 weeks of usual care alone (i.e., control group). The CARE4STROKE program is compiled in consultation with a trained physical therapist. A tablet computer is used to present video-based exercises for gait and gait-related activities in which a caregiver acts as an exercise coach. Primary outcomes are the mobility domain of the Stroke Impact Scale and length of stay. Secondary outcomes are the other domains of the Stroke Impact Scale, motor impairment, strength, walking ability, balance, mobility, (Extended) Activities of Daily Living, psychosocial functioning, self-efficacy, fatigue, health-related quality of life of the patient as well as the experienced strain, psychosocial functioning and quality of life of the caregiver. An economic evaluation will be conducted from the societal and health care perspective. DISCUSSION: The main aspects of the CARE4STROKE program are 1) increasing intensity of training by doing exercises with a caregiver in addition to usual care and 2) e-health support. We hypothesize this program leads to better functional outcome and early supported discharge, resulting in reduced costs. TRIAL REGISTRATION: The study is registered in the Dutch trial register as NTR4300, registered 2 December 2013.

How Do Fugl-Meyer Arm Motor Scores Relate to Dexterity According to the Action Research Arm Test at 6 Months Poststroke?

OBJECTIVE: To determine the optimal cutoff scores for the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) with regard to predicting no, poor, limited, notable, or full upper-limb capacity according to frequently used cutoff points for the Action Research Arm Test (ARAT) at 6 months poststroke. DESIGN: Prospective. SETTING: Rehabilitation center. PARTICIPANTS: Patients (N=460) with a first-ever ischemic stroke at 6 months poststroke. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Based on the ARAT classification of poor to full upper-limb capacity, receiver operating characteristic curves were used to calculate the area under the curve, optimal cutoff points for the FMA-UE were determined, and a weighted kappa was used to assess the agreement. RESULTS: FMA-UE scores of 0 through 22 represent no upper-limb capacity (ARAT 0-10); scores of 23 through 31 represent poor capacity (ARAT 11-21); scores of 32 through 47 represent limited capacity (ARAT 22-42); scores of 48 through 52 represent notable capacity (ARAT 43-54); and scores of 53 through 66 represent full upper-limb capacity (ARAT 55-57). Overall, areas under the curve ranged from .916 (95% confidence interval [CI], .890-.943) to .988 (95% CI, .978-.998; P<.001). CONCLUSIONS: There is considerable overlap in the area under the curve between the ARAT and FMA-UE. FMA-UE scores >31 points correspond to no to poor arm-hand capacity (ie, ≤21 points) on the ARAT, whereas FMA-UE scores >31 correspond to limited to full arm-hand capacity (ie, ≥22 points) on the ARAT.

Functional recovery of the paretic upper limb after stroke: who regains hand capacity?

OBJECTIVE: To describe recovery of upper limb capacity after stroke during inpatient rehabilitation based on the Stroke Upper Limb Capacity Scale (SULCS). DESIGN: Prospective observational study. SETTING: Inpatient department of a rehabilitation center. PARTICIPANTS: Patients with stroke (N=299) admitted to a specialized stroke rehabilitation center. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Upper limb capacity was assessed at the start and end of the rehabilitation phase with the SULCS (range, 0-10). The following demographic and clinical characteristics were registered: age, sex, side of stroke, stroke type, time since stroke, and length of stay in the rehabilitation center. RESULTS: On admission, 125 patients had no hand capacity (SULCS score, 0-3), 58 had basic hand capacity (SULCS score, 4-7), and 116 had advanced hand capacity (SULCS score, 8-10). Of the patients without initial hand capacity, 41% regained some hand capacity (SULCS score, ≥4) at discharge. Of these, patients with SULCS scores of 2 and 3 had 29 and 97 times greater chance of regaining some hand capacity compared with patients with an initial SULCS score of 0, respectively. Of the patients with initial basic hand capacity, 78% regained advanced hand capacity at discharge. The SULCS score on admission explained 51% of the SULCS score variance at discharge, while time since stroke was negatively associated with upper limb recovery, explaining an additional 7% of the SULCS score variance at discharge. CONCLUSIONS: Even patients with minimal proximal shoulder and elbow control of the upper paretic limb on admission in a rehabilitation center have a fair chance of regaining some hand capacity in the long-term after stroke, whereas patients without such proximal arm control have a much poorer prognosis for regaining hand capacity.

Comparing two identically protocolized, multicentre, randomized controlled trials on caregiver-mediated exercises poststroke: Any differences across countries?

BACKGROUND: The evidence for rehabilitation interventions poststroke lack sufficient robustness. However, variation in treatment effects across countries have been given little attention. OBJECTIVE: To compare two identically protocolized trials conducted in different western countries in order to identify factors that may have caused variation in secondary trial outcomes. METHODS: Comparative study based on individual patient data (N = 129) from two randomized controlled trials, conducted in hospitals and rehabilitation facilities in the Netherlands (N = 66) and Australia (N = 63). Patients with stroke and their caregivers were randomly allocated to an 8-week caregiver-mediated exercises intervention (N = 63; 31 Australian and 32 Dutch) or to a control group (N = 66; 32 Australian and 34 Dutch). Patient characteristics, compliance, usual care and process measures were compared across countries. We examined if study setting significantly moderated the trial outcomes: Hospital Anxiety and Depression Scale, Fatigue Severity Scale and General Self-Efficacy Scale, measured at 8- and 12 weeks follow-up. In addition, we explored if factors that were significantly different across countries caused variation in these trial outcomes. RESULTS: Most patients suffered an ischemic stroke, were in the subacute phase and participated with their partner. Dutch patients were younger (P = 0.005) and had a lower functional status (P = 0.001). Australian patients were recruited earlier poststroke (P<0.001), spent less time in exercise therapy (P<0.001) and had a shorter length of stay (P<0.001). The level of contamination was higher (P = 0.040) among Dutch controls. No effect modification was observed and trial outcomes did not change after controlling for cross-country differences. CONCLUSIONS: The present study highlighted important clinical differences across countries whilst using an identical study protocol. The observed differences could result in a different potential for recovery and variation in treatment effects across trials. We argue that we can proceed faster to evaluating interventions within international pragmatic trials.

TMS-Induced Central Motor Conduction Time at the Non-Infarcted Hemisphere Is Associated with Spontaneous Motor Recovery of the Paretic Upper Limb after Severe Stroke.

BACKGROUND: Stroke affects the neuronal networks of the non-infarcted hemisphere. The central motor conduction time (CMCT) induced by transcranial magnetic stimulation (TMS) could be used to determine the conduction time of the corticospinal tract of the non-infarcted hemisphere after a stroke. OBJECTIVES: Our primary aim was to demonstrate the existence of prolonged CMCT in the non-infarcted hemisphere, measured within the first 48 h when compared to normative data, and secondly, if the severity of motor impairment of the affected upper limb was significantly associated with prolonged CMCTs in the non-infarcted hemisphere when measured within the first 2 weeks post stroke. METHODS: CMCT in the non-infarcted hemisphere was measured in 50 patients within 48 h and at 11 days after a first-ever ischemic stroke. Patients lacking significant spontaneous motor recovery, so-called non-recoverers, were defined as those who started below 18 points on the FM-UE and showed less than 6 points (10%) improvement within 6 months. RESULTS: CMCT in the non-infarcted hemisphere was prolonged in 30/50 (60%) patients within 48 h and still in 24/49 (49%) patients at 11 days. Sustained prolonged CMCT in the non-infarcted hemisphere was significantly more frequent in non-recoverers following FM-UE. CONCLUSIONS: The current study suggests that CMCT in the non-infarcted hemisphere is significantly prolonged in 60% of severely affected, ischemic stroke patients when measured within the first 48 h post stroke. The likelihood of CMCT is significantly higher in non-recoverers when compared to those that show spontaneous motor recovery early post stroke.

Presence of finger extension and shoulder abduction within 72 hours after stroke predicts functional recovery: early prediction of functional outcome after stroke: the EPOS cohort study.

BACKGROUND AND PURPOSE: The aim of the present study was to determine if outcome in terms of upper limb function at 6 months after stroke can be predicted in hospital stroke units using clinical parameters measured within 72 hours after stroke. In addition, the effect of the timing of assessment after stroke on the accuracy of prediction was investigated by measurements on days 5 and 9. METHODS: Candidate determinants were measured in 188 stroke patients within 72 hours and at 5 and 9 days after stroke. Logistic regression analysis was used for model development to predict upper limb function at 6 months measured with the action research arm test (ARAT). RESULTS: Patients with an upper limb motor deficit who exhibit some voluntary extension of the fingers and some abduction of the hemiplegic shoulder on day 2 have a probability of 0.98 to regain some dexterity at 6 months, whereas the probability was 0.25 for those without this voluntary motor activity. Sixty percent of patients with some early finger extension achieved full recovery at 6 months in terms of action research arm test score. Retesting the model on days 5 and 9 resulted in a gradual decline in probability from 0.25 to 0.14 for those without voluntary motor activity of shoulder abduction and finger extension, whereas the probability remained 0.98 for those with this motor activity. CONCLUSIONS: Based on 2 simple bedside tests, finger extension and shoulder abduction, functional recovery of the hemiplegic arm at 6 months can be predicted early in a hospital stroke unit within 72 hours after stroke onset.

Is Recovery of Somatosensory Impairment Conditional for Upper-Limb Motor Recovery Early After Stroke?

Background. Spontaneous recovery early after stroke is most evident during a time-sensitive window of heightened neuroplasticity, known as spontaneous neurobiological recovery. It is unknown whether poststroke upper-limb motor and somatosensory impairment both reflect spontaneous neurobiological recovery or if somatosensory impairment and/or recovery influences motor recovery. Methods. Motor (Fugl-Meyer upper-extremity [FM-UE]) and somatosensory impairments (Erasmus modification of the Nottingham Sensory Assessment [EmNSA-UE]) were measured in 215 patients within 3 weeks and at 5, 12, and 26 weeks after a first-ever ischemic stroke. The longitudinal association between FM-UE and EmNSA-UE was examined in patients with motor and somatosensory impairments (FM-UE ≤ 60 and EmNSA-UE ≤ 37) at baseline. Results. A total of 94 patients were included in the longitudinal analysis. EmNSA-UE increased significantly up to 12 weeks poststroke. The longitudinal association between motor and somatosensory impairment disappeared when correcting for progress of time and was not significantly different for patients with severe baseline somatosensory impairment. Patients with a FM-UE score ≥18 at 26 weeks (n = 55) showed a significant positive association between motor and somatosensory impairments, irrespective of progress of time. Conclusions. Progress of time, as a reflection of spontaneous neurobiological recovery, is an important factor that drives recovery of upper-limb motor as well as somatosensory impairments in the first 12 weeks poststroke. Severe somatosensory impairment at baseline does not directly compromise motor recovery. The study rather suggests that spontaneous recovery of somatosensory impairment is a prerequisite for full motor recovery of the upper paretic limb.

Comparison of self-reported vs observational clinical measures of improvement in upper limb capacity in patients after stroke.

OBJECTIVE: Recovery of the paretic arm post-stroke can be assessed using observational and self-reported measures. The aim of this study was to determine whether the correspondence (match) or non-correspondence (mismatch) between observational and self-reported improvements in upper limb capacity are significantly different at 0-3 months compared with 3-6 months post-stroke. METHODS: A total of 159 patients with ischaemic stroke with upper limb paresis were included in the study. Recovery of arm capacity was measured with observational (Action Research Arm Test; ARAT) and self-reported measures (Motor Activity Log Quality of Movement; MAL-QOM and Stroke Impact Scale Hand; SIS-Hand) at 0-3 and 3-6 months post-stroke. The proportion of matches was defined (contingency tables and Fisher's exact test) and compared across the different time-windows using McNemar's test. RESULTS: The proportion of matches was not significantly different at 0-3 months compared with 3-6 months post-stroke for the ARAT vs MAL-QOM and SIS-Hand (all p > 0.05). In case of mismatches, patients' self-reports were more often pessimistic (86%) in the first 3 months post-stroke compared with the subsequent 3 months (39%). CONCLUSION: The match between observational and self-reported measures of upper limb capacity is not dependent on the timing of assessment post-stroke. Assessment of both observational and self-reported measures may help to recognize possible over- or under-estimation of improvement in upper limb capacity post-stroke.

Patient characteristics related to the need for peer support in rehabilitation after acquired brain injury: a prospective cohort study in the Netherlands.

OBJECTIVE: Peer support facilitates patients and caregivers in adjusting to long-term disabilities. This study aimed to determine which patient characteristics are related to need for peer support during rehabilitation after acquired brain injury (ABI) and investigate factors that explain whether peer support is perceived as meaningful or not. DESIGN: A prospective cohort study over a period of 17 months following patients with ABI during inpatient rehabilitation in the Netherlands. Multivariable logistic modelling was applied to identify patient and intervention characteristics that were related to (1) need for peer support and (2) whether or not peer support was perceived as meaningful. Additional information on duration and subjects of conversation was reported. SETTING: Peer support was provided during inpatient rehabilitation. PARTICIPANTS: 120 patients with ABI ≥18 years were included and assessed at admission, 94 patients were assessed at discharge. Seventy-three percent (n=88) expressed a need for peer support and at discharge 76.6% (n=72) perceived contact as meaningful. RESULTS: Non-Western and single patients perceived a significantly higher need for peer support. Patients younger than 60 and those with time between ABI and discharge of >3 months perceived their contact significantly more meaningful. CONCLUSIONS: Results provide more insight into characteristics of patients with ABI who may benefit from peer support during inpatient rehabilitation. Optimal dosage, length of contact, rehabilitation phase and strategy for the provision of peer support should be investigated as well as the effects for ABI survivors on outcomes such as coping, self-efficacy, depression and health-related quality of life.

The effect of cerebellar transcranial direct current stimulation to improve standing balance performance early post-stroke, study protocol of a randomized controlled trial.

RATIONALE: Restoration of adequate standing balance after stroke is of major importance for functional recovery. POstural feedback ThErapy combined with Non-invasive TranscranIAL direct current stimulation (tDCS) in patients with stroke (POTENTIAL) aims to establish if cerebellar tDCS has added value in improving standing balance performance early post-stroke. METHODS: Forty-six patients with a first-ever ischemic stroke will be enrolled in this double-blind controlled trial within five weeks post-stroke. All patients will receive 15 sessions of virtual reality-based postural feedback training (VR-PFT) in addition to usual care. VR-PFT will be given five days per week for 1 h, starting within five weeks post-stroke. During VR-PFT, 23 patients will receive 25 min of cerebellar anodal tDCS (cb_tDCS), and 23 patients will receive sham stimulation. STUDY OUTCOME: Clinical, posturographic, and neurophysiological measurements will be performed at baseline, directly post-intervention, two weeks post-intervention and at 15 weeks post-stroke. The primary outcome measure will be the Berg Balance Scale (BBS) for which a clinical meaningful difference of six points needs to be established between the intervention and control group at 15 weeks post-stroke. DISCUSSION: POTENTIAL will be the first proof-of-concept randomized controlled trial to assess the effects of VR-PFT combined with cerebellar tDCS in terms of standing balance performance in patients early post-stroke. Due to the combined clinical, posturographical and neurophysiological measurements, this trial may give more insights in underlying post-stroke recovery processes and whether these can be influenced by tDCS.

Caregiver-mediated exercises with e-health support for early supported discharge after stroke (CARE4STROKE): A randomized controlled trial.

BACKGROUND AND PURPOSE: We designed an 8-week caregiver-mediated exercise program with e-health support after stroke (CARE4STROKE) in addition to usual care with the aim to improve functional outcome and to facilitate early supported discharge by increasing the intensity of task specific training. METHODS: An observer-blinded randomized controlled trial in which 66 stroke patient-caregiver couples were included during inpatient rehabilitation. Patients allocated to the CARE4STROKE program trained an additional amount of 150 minutes a week with a caregiver and were compared to a control group that received usual care alone. Primary outcomes: self-reported mobility domain of the Stroke Impact Scale 3.0 (SIS) and length of stay (LOS). Secondary outcomes: motor impairment, strength, walking ability, balance, mobility and (Extended) Activities of Daily Living of patients, caregiver strain of caregivers, and mood, self-efficacy, fatigue and quality of life of both patients and caregivers. Outcomes were assessed at baseline, 8 and 12 weeks after randomization. RESULTS: No significant between-group differences were found regarding SIS-mobility after 8 (ß 6.21, SD 5.16; P = 0.229) and 12 weeks (ß 0.14, SD 2.87; P = 0.961), and LOS (P = 0.818). Significant effects in favor of the intervention group were found for patient's anxiety (ß 2.01, SD 0.88; P = 0.023) and caregiver's depression (ß 2.33, SD 0.77; P = 0.003) post intervention. Decreased anxiety in patients remained significant at the 12-week follow-up (ß 1.01, SD 0.40; P = 0.009). CONCLUSIONS: This proof-of concept trial did not find significant effects on both primary outcomes mobility and LOS as well as the secondary functional outcomes. Treatment contrast in terms of total exercise time may have been insufficient to achieve these effects. However, caregiver-mediated exercises showed a favorable impact on secondary outcome measures of mood for both patient and caregiver. CLINICAL TRIAL REGISTRATION: NTR4300, URL- http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4300.

Does Transcranial Magnetic Stimulation Have an Added Value to Clinical Assessment in Predicting Upper-Limb Function Very Early After Severe Stroke?

BACKGROUND: The added prognostic value of transcranial magnetic stimulation (TMS)-induced motor-evoked potentials (MEPs) to clinical modeling for the upper limb is still unknown early poststroke. OBJECTIVE: To determine the added prognostic value of TMS of the adductor digiti minimi (TMS-ADM) to the clinical model based on voluntary shoulder abduction (SA) and finger extension (FE) during the first 48 hours and at 11 days after stroke. METHODS: This was a prospective cohort study with 3 logistic regression models, developed to predict upper-limb function at 6 months poststroke. The first model showed the predictive value of SA and FE measured within 48 hours and at 11 days poststroke. The second model included TMS-ADM, whereas the third model combined clinical and TMS-ADM information. Differences between derived models were tested with receiver operating characteristic curve analyses. RESULTS: A total of 51 patients with severe, first-ever ischemic stroke were included. Within 48 hours, no significant added value of TMS-ADM to clinical modeling was found ( P = .369). Both models suffered from a relatively low negative predictive value within 48 hours poststroke. TMS-ADM combined with SA and FE (SAFE) showed significantly more accuracy than TMS-ADM alone at 11 days poststroke ( P = .039). CONCLUSION: TMS-ADM showed no added value to clinical modeling when measured within first 48 hours poststroke, whereas optimal prediction is achieved by SAFE combined with TMS-ADM at 11 days poststroke. Our findings suggest that accuracy of predicting upper-limb motor function by TMS-ADM is mainly determined by the time of assessment early after stroke onset.

Moving stroke rehabilitation forward: The need to change research.

BACKGROUND: Stroke rehabilitation aims to reduce impairments and promote activity and participation among patients. A major challenge for stroke rehabilitation research is to develop interventions that can reduce patients' neurological impairments. Until now, there has been no breakthrough in this research field. To move stroke rehabilitation forward, we need more knowledge about underlying mechanisms that drive spontaneous (i.e., reactive) neurobiological recovery after stroke and factors that can be used to optimize its prediction early after stroke onset. OBJECTIVE: The aim of the present invited review was therefore to elaborate on the time window of reactive neurobiological recovery, the proportional recovery rule and its generalizability to other neurological impairments, as well as to discuss the consequences for designing stroke recovery and rehabilitation trials. METHODS: In this narrative review, we offer suggestions to optimize the research designs of future stroke rehabilitation and recovery trials post stroke, in order to overcome the current prognostic heterogeneity introduced by variations in the potential for reactive neurobiological recovery. FINDINGS AND CONCLUSIONS: There is an urgent need for high-quality, explanatory trials in the first three months post stroke. These trials should preferably stratify patients based on their initial potential for reactive neurobiological recovery, measure recovery repeatedly at fixed times post stroke, and differentiate in their outcomes between behavioural restitution and compensation of functions.

When Does Return of Voluntary Finger Extension Occur Post-Stroke? A Prospective Cohort Study.

OBJECTIVES: Patients without voluntary finger extension early post-stroke are suggested to have a poor prognosis for regaining upper limb capacity at 6 months. Despite this poor prognosis, a number of patients do regain upper limb capacity. We aimed to determine the time window for return of voluntary finger extension during motor recovery and identify clinical characteristics of patients who, despite an initially poor prognosis, show upper limb capacity at 6 months post-stroke. METHODS: Survival analysis was used to assess the time window for return of voluntary finger extension (Fugl-Meyer Assessment hand sub item finger extension≥1). A cut-off of ≥10 points on the Action Research Arm Test was used to define return of some upper limb capacity (i.e. ability to pick up a small object). Probabilities for regaining upper limb capacity at 6 months post-stroke were determined with multivariable logistic regression analysis using patient characteristics. RESULTS: 45 of the 100 patients without voluntary finger extension at 8 ± 4 days post-stroke achieved an Action Research Arm Test score of ≥10 points at 6 months. The median time for regaining voluntary finger extension for these recoverers was 4 weeks (lower and upper percentile respectively 2 and 8 weeks). The median time to return of VFE was not reached for the whole group (N = 100). Patients who had moderate to good lower limb function (Motricity Index leg≥35 points), no visuospatial neglect (single-letter cancellation test asymmetry between the contralesional and ipsilesional sides of <2 omissions) and sufficient somatosensory function (Erasmus MC modified Nottingham Sensory Assessment≥33 points) had a 0.94 probability of regaining upper limb capacity at 6 months post-stroke. CONCLUSIONS: We recommend weekly monitoring of voluntary finger extension within the first 4 weeks post-stroke and preferably up to 8 weeks. Patients with paresis mainly restricted to the upper limb, no visuospatial neglect and sufficient somatosensory function are likely to show at least some return of upper limb capacity at 6 months post-stroke.