Novel multi-pad functional electrical stimulation in stroke patients: A single-blind randomized study.

BACKGROUND: Foot drop is common gait impairment after stroke. Functional electrical stimulation (FES) of the ankle dorsiflexor muscles during the swing phase of gait can help correcting foot drop. OBJECTIVE: To evaluate efficacy of additional novel FES system to conventional therapy in facilitating motor recovery in the lower extremities and improving walking ability after stroke. METHODS: Sixteen stroke patients were randomly allocated to the FES group (FES therapy plus conventional rehabilitation program) (n = 8), and control group (conventional rehabilitation program) n = 8. FES was delivered for 30 min during gait to induce ankle plantar and dorsiflexion. MAIN OUTCOME MEASURES: gait speed using 10 Meter Walk Test (10 MWT), Fugl-Meyer Assessment (FMA), Berg Balance Scale (BBS) and modified Barthel Index (MBI). RESULTS: Results showed a significant increase in gait speed in FES group (p < 0.001), higher than the minimal detected change. The FES group showed improvement in functional independence in the activities of daily living, motor recovery and gait performance. CONCLUSIONS: The findings suggest that novel FES therapy combined with conventional rehabilitation is more effective on walking speed, mobility of the lower extremity, balance disability and activities of daily living compared to a conventional rehabilitation program only.

Temporal and Spatial Variability of Surface Motor Activation Zones in Hemiplegic Patients During Functional Electrical Stimulation Therapy Sessions.

The goal of this study was to investigate surface motor activation zones and their temporal variability using an advanced multi-pad functional electrical stimulation system. With this system motor responses are elicited through concurrent activation of electrode matrix pads collectively termed "virtual electrodes" (VEs) with appropriate stimulation parameters. We observed VEs used to produce selective wrist, finger, and thumb extension movements in 20 therapy sessions of 12 hemiplegic stroke patients. The VEs which produce these three selective movements were created manually on the ergonomic multi-pad electrode by experienced clinicians based on visual inspection of the muscle responses. Individual results indicated that changes in VE configuration were required each session for all patients and that overlap in joint movements was evident between some VEs. However, by analyzing group data, we defined the probability distribution over the electrode surface for the three VEs of interest. Furthermore, through Bayesian logic we obtained preferred stimulation zones that are in accordance with our previously reported heuristically obtained results. We have also analyzed the number of active pads and stimulation amplitudes for these three VEs. Presented results provide a basis for an automated electrode calibration algorithm built on a priori knowledge or the starting point for manual selection of stimulation points.

A decision support system for electrode shaping in multi-pad FES foot drop correction.

BACKGROUND: Functional electrical stimulation (FES) can be applied as an assistive and therapeutic aid in the rehabilitation of foot drop. Transcutaneous multi-pad electrodes can increase the selectivity of stimulation; however, shaping the stimulation electrode becomes increasingly complex with an increasing number of possible stimulation sites. We described and tested a novel decision support system (DSS) to facilitate the process of multi-pad stimulation electrode shaping. The DSS is part of a system for drop foot treatment that comprises a custom-designed multi-pad electrode, an electrical stimulator, and an inertial measurement unit. METHODS: The system was tested in ten stroke survivors (3-96 months post stroke) with foot drop over 20 daily sessions. The DSS output suggested stimulation pads and parameters based on muscle twitch responses to short stimulus trains. The DSS ranked combinations of pads and current amplitudes based on a novel measurement of the quality of the induced movement and classified them based on the movement direction (dorsiflexion, plantar flexion, eversion and inversion) of the paretic foot. The efficacy of the DSS in providing satisfactory pad-current amplitude choices for shaping the stimulation electrode was evaluated by trained clinicians. The range of paretic foot motion was used as a quality indicator for the chosen patterns. RESULTS: The results suggest that the DSS output was highly effective in creating optimized FES patterns. The position and number of pads included showed pronounced inter-patient and inter-session variability; however, zones for inducing dorsiflexion and plantar flexion within the multi-pad electrode were clearly separated. The range of motion achieved with FES was significantly greater than the corresponding active range of motion (p < 0.05) during the first three weeks of therapy. CONCLUSIONS: The proposed DSS in combination with a custom multi-pad electrode design covering the branches of peroneal and tibial nerves proved to be an effective tool for producing both the dorsiflexion and plantar flexion of a paretic foot. The results support the use of multi-pad electrode technology in combination with automatic electrode shaping algorithms for the rehabilitation of foot drop. TRIAL REGISTRATION: This study was registered at the Current Controlled Trials website with ClinicalTrials.gov ID NCT02729636 on March 29, 2016.

ArmAssist Robotic System versus Matched Conventional Therapy for Poststroke Upper Limb Rehabilitation: A Randomized Clinical Trial.

The ArmAssist is a simple low-cost robotic system for upper limb motor training that combines known benefits of repetitive task-oriented training, greater intensity of practice, and less dependence on therapist assistance. The aim of this preliminary study was to compare the efficacy of ArmAssist (AA) robotic training against matched conventional arm training in subacute stroke subjects with moderate-to-severe upper limb impairment. Twenty-six subjects were enrolled within 3 months of stroke and randomly assigned to the AA group or Control group (n = 13 each). Both groups were trained 5 days per week for 3 weeks. The primary outcome measure was Fugl-Meyer Assessment-Upper Extremity (FMA-UE) motor score, and the secondary outcomes were Wolf Motor Function Test-Functional Ability Scale (WMFT-FAS) and Barthel index (BI). The AA group, in comparison to the Control group, showed significantly greater increases in FMA-UE score (18.0 ± 9.4 versus 7.5 ± 5.5, p = 0.002) and WMFT-FAS score (14.1 ± 7.9 versus 6.7 ± 7.8, p = 0.025) after 3 weeks of treatment, whereas the increase in BI was not significant (21.2 ± 24.8 versus 13.1 ± 10.7, p = 0.292). There were no adverse events. We conclude that arm training using the AA robotic device is safe and able to reduce motor deficits more effectively than matched conventional arm training in subacute phase of stroke. The study has been registered at the ClinicalTrials.gov, ID: NCT02729649.

Evolution of Surface Motor Activation Zones in Hemiplegic Patients During 20 Sessions of FES Therapy with Multi-pad Electrodes.

The purpose of this study was to examine surface motor activation zones for wrist, fingers and thumb extension movements and their temporal change during 20 therapy sessions using advanced multi-pad functional electrical stimulation system. Results from four hemiplegic patients indicate that certain zones have higher probability of eliciting each of the target movements. However, mutual overlap and variations of the zones are present not just between the subjects, but also on the intrasubject level, reflected through these session to session transformations of the selected virtual electrodes. The obtained results could be used as a priori knowledge for semi-automated optimization algorithm and could shorten the time required for calibration of the multi-pad electrode.

Maternal plasma n-3 and n-6 polyunsaturated fatty acid concentrations during pregnancy and subcutaneous fat mass in infancy.

OBJECTIVE: The associations of maternal plasma n-3 and n-6 polyunsaturated fatty acid (PUFA) concentrations during pregnancy with infant subcutaneous fat were examined. METHODS: In a population-based prospective cohort study among 904 mothers and their infants, maternal plasma n-3 and n-6 PUFA concentrations were measured at midpregnancy. Body mass index, total subcutaneous fat, and central-to-total subcutaneous fat ratio were calculated at 1.5, 6, and 24 months. RESULTS: Maternal n-3 PUFA levels were not consistently associated with infant body mass index or total subcutaneous fat. Higher maternal total n-3 PUFA levels, and specifically eicosapentaenoic acid, docosapentaenoic acid, and docosahexaenoic acid, were associated with higher central-to-total subcutaneous fat ratio at 1.5 months, whereas higher maternal total n-3 PUFA levels were associated with lower central-to-total subcutaneous fat ratio at 6 months (all P values < 0.05). These associations were not present at 24 months. Maternal n-6 PUFA levels were not consistently associated with infant subcutaneous fat. A higher n-6/n-3 ratio was associated with lower central-to-total subcutaneous fat ratio at 1.5 months only (P value < 0.05). CONCLUSIONS: Maternal n-3 PUFA levels during pregnancy may have transient effects on infant subcutaneous fat. Further studies are needed to assess the effects of maternal PUFA concentrations on fat mass development during early infancy.

Maternal plasma PUFA concentrations during pregnancy and childhood adiposity: the Generation R Study.

BACKGROUND: Maternal polyunsaturated fatty acid (PUFA) concentrations during pregnancy may have persistent effects on growth and adiposity in the offspring. A suboptimal maternal diet during pregnancy might lead to fetal cardiometabolic adaptations with persistent consequences in the offspring. OBJECTIVE: We examined the associations of maternal PUFA concentrations during pregnancy with childhood general and abdominal fat-distribution measures. DESIGN: In a population-based, prospective cohort study of 4830 mothers and their children, we measured maternal second-trimester plasma n-3 (ω-3) and n-6 (ω-6) PUFA concentrations. At the median age of 6.0 y (95% range: 5.6, 7.9 y), we measured childhood body mass index (BMI), the fat mass percentage, and the android:gynoid fat ratio with the use of dual-energy X-ray absorptiometry and measured the preperitoneal abdominal fat area with the use of ultrasound. Analyses were adjusted for maternal and childhood sociodemographic- and lifestyle-related characteristics. RESULTS: We observed that higher maternal total n-3 PUFA concentrations, and specifically those of eicosapentaenoic acid, docosapentaenoic acid, and docosahexaenoic acid, were associated with a lower childhood total-body fat percentage and a lower android:gynoid fat mass ratio (P< 0.05) but not with childhood BMI and the abdominal preperitoneal fat mass area. Higher maternal total n-6 PUFA concentrations, and specifically those of dihomo-γ-linolenic acid, were associated with a higher childhood total-body fat percentage, android:gynoid fat mass ratio, and abdominal preperitoneal fat mass area (P< 0.05) but not with childhood BMI. In line with these findings, a higher maternal n-6:n-3 PUFA ratio was associated with higher childhood total-body and abdominal fat mass. CONCLUSIONS: Lower maternal n-3 PUFA concentrations and higher n-6 PUFA concentrations during pregnancy are associated with higher body fat and abdominal fat in childhood. Additional studies are needed to replicate these observations and to explore the causality, the underlying pathways, and the long-term cardiometabolic consequences.

Body mass index, gestational weight gain and fatty acid concentrations during pregnancy: the Generation R Study.

Obesity during pregnancy may be correlated with an adverse nutritional status affecting pregnancy and offspring outcomes. We examined the associations of prepregnancy body mass index and gestational weight gain with plasma fatty acid concentrations in mid-pregnancy. This study was embedded in a population-based prospective cohort study among 5636 women. We obtained prepregnancy body mass index and maximum weight gain during pregnancy by questionnaires. We measured concentrations of saturated fatty acid (SFA), monounsaturated fatty acid (MUFA), n-3 polyunsaturated fatty acid (n-3 PUFA) and n-6 polyunsaturated fatty acid (n-6 PUFA) at a median gestational age of 20.5 (95% range 17.1-24.9) weeks. We used multivariate linear regression models. As compared to normal weight women, obese women had higher total SFA concentrations [difference: 0.10 standard deviation (SD) (95% Confidence Interval (CI) 0, 0.19)] and lower total n-3 PUFA concentrations [difference: - 0.11 SD (95% CI - 0.20, - 0.02)]. As compared to women with sufficient gestational weight gain, those with excessive gestational weight gain had higher SFA concentrations [difference: 0.16 SD (95% CI 0.08, 0.25)], MUFA concentrations [difference: 0.16 SD (95% CI 0.08, 0.24)] and n-6 PUFA concentrations [difference: 0.12 SD (95% CI 0.04, 0.21)]. These results were not materially affected by adjustment for maternal characteristics. Our results suggest that obesity and excessive weight gain during pregnancy are associated with an adverse fatty acids profile. Further studies are needed to assess causality and direction of the observed associations.

Higher Maternal Plasma n-3 PUFA and Lower n-6 PUFA Concentrations in Pregnancy Are Associated with Lower Childhood Systolic Blood Pressure.

BACKGROUND: Suboptimal maternal diet during pregnancy might lead to fetal cardiovascular adaptations with persistent consequences in the offspring. OBJECTIVE: We assessed the associations of maternal polyunsaturated fatty acid (PUFA) concentrations during pregnancy with childhood blood pressure. METHODS: In a population-based prospective cohort study among 4455 mothers and their children, we measured maternal second-trimester n-3 (ω-3) and n-6 (ω-6) PUFA concentrations in plasma glycerophospholipids and expressed n-3 and n-6 PUFAs as proportions of total PUFAs (wt%). Childhood blood pressure was measured at the median age of 6.0 y (95% range: 5.7-7.9 y). We used linear regression models to assess the associations of maternal PUFA wt% with childhood blood pressure at 6 y. RESULTS: Higher total maternal n-3 PUFA wt% and, specifically, docosahexaenoic acid (DHA; 22:6n-3) wt% were associated with lower childhood systolic blood pressure [differences: -0.28 (95% CI: -0.54, -0.03) and -0.29 mm Hg (95% CI: -0.54, -0.03) per SD increase of total n-3 PUFAs and DHA wt%, respectively], but not with childhood diastolic blood pressure. Total maternal n-6 PUFA wt% was positively associated with childhood systolic blood pressure [differences: 0.36 mm Hg (95% CI: 0.09, 0.62) per SD increase of total n-6 PUFA wt%], but not with childhood diastolic blood pressure. A higher n-6:n-3 PUFA ratio was associated with higher childhood systolic blood pressure (P < 0.05). Pregnancy and childhood characteristics only partly explained the observed associations. CONCLUSIONS: Higher maternal plasma n-3 PUFA and lower n-6 PUFA concentrations during pregnancy are associated with a lower systolic blood pressure in childhood. Further studies are needed to replicate these findings, explore the underlying mechanisms, and examine the long-term cardiovascular consequences.