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7 result(s) for "Bujan, Bartosz"
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Clinical validation of a contactless respiration rate monitor
Respiratory rate (RR) is an often underestimated and underreported vital sign with tremendous clinical value. As a predictor of cardiopulmonary arrest, chronic obstructive pulmonary disease (COPD) exacerbation or indicator of health state for example in COVID-19 patients, respiratory rate could be especially valuable in remote long-term patient monitoring, which is challenging to implement. Contactless devices for home use aim to overcome these challenges. In this study, the contactless Sleepiz One+ respiration monitor for home use during sleep was validated against the thoracic effort belt. The agreement of instantaneous breathing rate and breathing rate statistics between the Sleepiz One+ device and the thoracic effort belt was initially evaluated during a 20-min sleep window under controlled conditions (no body movement) on a cohort of 19 participants and secondly in a more natural setting (uncontrolled for body movement) during a whole night on a cohort of 139 participants. Excellent agreement was shown for instantaneous breathing rate to be within 3 breaths per minute (Brpm) compared to thoracic effort band with an accuracy of 100% and mean absolute error (MAE) of 0.39 Brpm for the setting controlled for movement, and an accuracy of 99.5% with a MAE of 0.48 Brpm for the whole night measurement, respectively. Excellent agreement was also achieved for the respiratory rate statistics over the whole night with absolute errors of 0.43, 0.39 and 0.67 Brpm for the 10th, 50th and 90th percentiles, respectively. Based on these results we conclude that the Sleepiz One+ can estimate instantaneous respiratory rate and its summary statistics at high accuracy in a clinical setting. Further studies are required to evaluate the performance in the home environment, however, it is expected that the performance is at similar level, as the measurement conditions for the Sleepiz One+ device are better at home than in a clinical setting.
The Effectiveness of Orofacial Myofunctional Therapy in Adults with Myogenous Temporomandibular Disorders: Insights from a Pilot Study
Temporomandibular disorders (TMDs) are increasingly understood within the biopsychosocial framework, which highlights the interplay of biological, psychological, and social factors in their onset and persistence. Within this context, orofacial myofunctional disorders (OMDs) represent a significant biological component, reflecting structural and functional disturbances of the orofacial system that may contribute to temporomandibular dysfunction. This pilot study evaluated the effectiveness of orofacial myofunctional therapy (OMT) in improving functional parameters and reducing pain in adults with myogenous TMD accompanied by OMDs. In this prospective single-arm pilot study, twenty-five adults (aged 25-39 years) with myogenous TMD and coexisting OMDs, diagnosed according to DC/TMD criteria by a dentist trained in DC/TMD assessment and referred for the intervention, completed three biweekly OMT sessions. The therapy comprised myofascial release, oromotor exercises, functional retraining of breathing, chewing, and swallowing, as well as mandibular stabilization and dissociation exercises, complemented by home-based practice. Functional parameters-maximum mouth opening (MAX) and tongue mobility (TRMR-TIP, TRMR-LPS)-were measured before and after each session. Pain intensity (VAS) and quality of life (SF-36) were assessed at baseline and post-intervention. Data were analyzed using the Shapiro-Wilk test, paired t-test, and Wilcoxon signed-rank test. : Statistically significant improvements ( < 0.001) were observed across all evaluated parameters. Participants demonstrated increased maximum mouth opening and tongue mobility, along with decreased pain intensity and improved quality of life following the intervention. : This pilot study provides preliminary evidence that short-term OMT can yield measurable functional improvements and pain reduction in adults with TMD and associated OMDs. These findings underscore the relevance of addressing orofacial myofunctional impairments as part of the biological dimension within the biopsychosocial model and support the integration of OMT into interdisciplinary TMD management.
Lower limb motor effects of DBS neurofeedback in Parkinson’s disease assessed through IMU-based UPDRS movement quality metrics
Parkinson’s disease (PD) is characterized by progressive motor impairments, including lower limb dysfunction, leading to reduced mobility and increased fall risk. To counteract these deficits, neurofeedback based on deep brain stimulation (DBS) electrodes has been proposed as a novel approach to mitigate motor symptoms via modulation of abnormal beta-oscillations in the subthalamic nucleus. However, its potential to improve motor symptoms has yet to be fully established. This study examined whether a single session of DBS-based neurofeedback could have a short term effect on movement quality, quantified through inertial measurement unit recordings. Ten PD patients performed two standardized motor tasks, foot stomping and hand pronation-supination, from the Unified Parkinson’s Disease Rating Scale. Movement quality metrics from inertial measurement units were extracted and compared before and after neurofeedback-induced beta-power downregulation. Beta-power was successfully reduced by -12.42% on average, and the reduction was associated with significant improvements in lower limb movement quality metrics—acceleration magnitude (p = 0.037), movement speed (steps per second: p = 0.010; mean peak velocity: p = 0.002), and reduced halts (p = 0.020)—with a strong coupling between beta reduction and speed gain (Spearman = 0.976, p < 0.001). No significant improvements were observed in upper limb movements. These findings indicate that neurofeedback-driven downregulation of beta-power produces measurable enhancements in lower limb movement quality, captured through wearable sensor metrics. Future work should assess whether these improvements translate into lasting functional benefits and validate the clinical relevance of these metrics.
EMG-Triggered Functional Electrical Stimulation for Central Facial Palsy Following Stroke: A Clinical Case Report
Background: Central facial palsy (CFP) is a common condition following stroke, typically affecting the lower face and causing symptoms such as drooling, dysarthria, and facial asymmetry. Despite available rehabilitation methods, the evidence supporting their effectiveness is limited. Electromyography (EMG)-triggered Functional Electrical Stimulation (FES) has shown promise in neurorehabilitation for motor impairments, but its application to CFP remains unclear. Methods: This case report explores the use of EMG-triggered FES in a 77-year-old patient with CFP following a severe ischemic stroke of the middle cerebral artery (MCA). Therapy, focused on stimulating the orbicularis oris muscle to address persistent drooling and improve facial symmetry, was alongside usual care. The stimulation duration was 5–15 min, frequency 35 Hz, and pulse duration 300 µs, applied 5 times a week. Stimulation duration was adjusted based on the patient’s progress. Results: The patient underwent 16 sessions of EMG-triggered FES over four weeks. Post-therapy reassessment with the Sunnybrook Facial Grading System (SFGS) showed an improvement in facial motor function, with the score increasing from 58/100 to 78/100. Reassessment of the Facial Disability Index (FDI) revealed significant improvement in physical function (55 to 85 points), though the social function score slightly decreased (76 to 64 points). Improvements in dysarthria and the complete resolution of drooling were reflected in the physical function domain of the FDI and the Allensbach Dysarthria Severity Scale. Conclusions: The results highlight that EMG-triggered FES was well tolerated and effectively supported therapy, contributing to the resolution of drooling, improved facial symmetry, and enhanced speech function. Future research should focus on randomized controlled trials to confirm its effectiveness and determine optimal therapy parameters.
Enhancement of STroke REhabilitation with Levodopa (ESTREL): Rationale and design of a randomized placebo-controlled, double blind superiority trial
Rationale: Novel therapeutic approaches are needed in stroke recovery. Whether pharmacological therapies are beneficial for enhancing stroke recovery is unclear. Dopamine is a neurotransmitter involved in motor learning, reward, and brain plasticity. Its prodrug levodopa is a promising agent for stroke recovery. Aim and hypothesis: To investigate the hypothesis that levodopa, in addition to standardized rehabilitation therapy based on active task training, results in an enhancement of functional recovery in acute ischemic or hemorrhagic stroke patients compared to placebo. Design: ESTREL (Enhancement of Stroke REhabilitation with Levodopa) is a randomized (ratio 1:1), multicenter, placebo-controlled, double-blind, parallel-group superiority trial. Participants: 610 participants (according to sample size calculation) with a clinically meaningful hemiparesis will be enrolled ⩽7 days after stroke onset. Key eligibility criteria include (i) in-hospital-rehabilitation required, (ii) capability to participate in rehabilitation, (iii) previous independence in daily living. Intervention: Levodopa 100 mg/carbidopa 25 mg three times daily, administered for 5 weeks in addition to standardized rehabilitation. The study intervention will be initiated within 7 days after stroke onset. Comparison: Matching placebo plus standardized rehabilitation. Outcomes: The primary outcome is the between-group difference of the Fugl-Meyer-Motor Assessment (FMMA) total score measured 3 months after randomization. Secondary outcomes include patient-reported health and wellbeing (PROMIS 10 and 29), patient-reported assessment of improvement, Rivermead Mobility Index, modified Rankin Scale, National Institutes of Health Stroke Scale (NIHSS), and as measures of harm: mortality, recurrent stroke, and serious adverse events. Conclusion: The ESTREL trial will provide evidence of whether the use of Levodopa in addition to standardized rehabilitation in stroke patients leads to better functional recovery compared to rehabilitation alone. Graphical abstract
ESTREL-Fatigue—association of levodopa with post-stroke fatigue
Abstract Introduction Post-stroke fatigue (PSF) is common and impacts stroke rehabilitation. Dopaminergic treatment may have beneficial effects on PSF. This study investigated whether levodopa, compared with placebo, was associated with a lower frequency or severity of PSF during in-hospital rehabilitation. Patients and methods Enhancement of Stroke Rehabilitation with Levodopa (ESTREL)-Fatigue was an exploratory analysis of secondary outcome data obtained in the multicentre, randomised, placebo-controlled ESTREL trial. Participants with acute stroke received levodopa 100 mg/carbidopa 25 mg or placebo 3 times daily for 39 days to enhance motor recovery. Participants who (i) reported fatigue at 5 weeks and who (ii) took at least 80% of the study medication were included in ESTREL-Fatigue. No adjustments for confounding were made. The primary endpoint was the presence of PSF at 5 weeks, defined as a T-score of ≥ 55 on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short-form-4a. As secondary endpoints, T-score cutoffs of ≥ 60 (moderate fatigue) and ≥ 70 (severe fatigue) were used. Binary logistic regression was used to compare PSF at 5 weeks between treatment groups. Results are presented as odds ratios (ORs) with 95% CI. Results A total of 456 of 505 (90.3%) participants were included (levodopa/placebo 235/221, median age 73 years, 41% female). Post-stroke fatigue at 5 weeks was present in 63/235 (26.8%) levodopa-treated participants and in 65/221 (29.4%) placebo-treated participants (OR: 0.88; 95% CI, 0.58–1.32; risk ratio 0.91; risk difference − 2.6%). For cutoffs of ≥ 60 and ≥ 70, ORs were 0.78 (95% CI, 0.43–1.41) and 0.8 (95% CI, 0.25–2.44), respectively. A sensitivity analysis as per intention-to-treat with all 610 randomised ESTREL participants also showed no significant difference in fatigue presence between levodopa and placebo groups (OR: 0.95; 95% CI, 0.65–1.39) and a sensitivity analysis using a mixed-effects logistic regression showed no evidence of centre-related clustering. Conclusion In ESTREL-Fatigue, levodopa, compared to placebo, was not associated with less PSF during in-hospital rehabilitation. Graphical Abstract Graphical Abstract
The impact of levodopa on post-stroke depression: the ESTREL-depression-study
Abstract Introduction Post-stroke depression (PSD) frequently occurs after acute stroke and negatively affects rehabilitation. Dopamine has beneficial effects on motivation and emotional stability. In stroke patients, low dopamine levels are linked to PSD. This study investigated whether levodopa treatment during in-hospital rehabilitation impacts PSD compared to placebo. Patients and methods ESTREL-Depression was a pre-planned analysis of the multicenter, randomized, double-blind, placebo-controlled ESTREL trial. Participants with an acute ischemic or hemorrhagic stroke were randomly assigned to receive either levodopa/carbidopa (100/25 mg) or placebo three times daily for 39 days. All ESTREL participants with (1) information about the presence or absence of depression at three months and (2) who took at least 80% of the study medication were eligible for the study. Participants with a history of depression were excluded. For the primary outcome, the presence of PSD was defined as having a T-score of ≥55 in the Patient-Reported Outcomes Measurement Information System short-form depression-4a 3 months after randomization. Binary logistic regression was performed to assess the effect of levodopa on PSD. Results The study included 407 ESTREL participants (median age 72, 60% male), 209 receiving levodopa, and 198 receiving placebo. At 3 months, the frequency and odds of PSD did not differ between the levodopa group (26%) and the placebo group (28%) (OR = 0.93, 95% CI, 0.60–1.43). Conclusion In the ESTREL-Depression study, treatment with levodopa had no impact on the occurrence of PSD. Clinical Trial Registration ClinicalTrials.gov: NCT03735901 (https://clinicaltrials.gov/study/NCT03735901). Graphical Abstract Graphical Abstract