Efficiency assessment of follow-up methodology of patients with knee replacement to predict post-surgical functionality: a protocol for randomised control PROKnee trial.

INTRODUCTION: Even when total knee arthroplasty (TKA) is an extended treatment, most patients experience a suboptimal evolution after TKA. The objectives of this study are the following: (1) to determine the effectiveness of two different prosthesis stabilisation systems on the functionality in activities of daily life, and (2) to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers and biomechanical functional evaluation to predict successful evolution. METHODS AND ANALYSIS: The PROKnee trial was designed as a randomised controlled patient-blinded trial with two parallel groups that are currently ongoing. The initial recruitment will be 99 patients scheduled for their first TKA, without previous prosthesis interventions in lower limbs, who will be randomly divided into two groups that differed in the stabilisation methodology incorporated in the knee prosthesis: the MEDIAL-pivot group and the CENTRAL-pivot group. The maximum walking speed will be reported as the primary outcome, and the secondary results will be patient-reported questionnaires related to physical status, cognitive and mental state, radiological test, laboratory analysis and biomechanical instrumented functional performance, such as the 6-minute walking test, timed up-and-go test, gait, sit-to-stand, step-over, and ability to step up and down stairs. All the results will be measured 1 week before TKA and at 1.5, 3, 6 and 12 months after surgery. ETHICS AND DISSEMINATION: All procedures were approved by the Ethical Committee for Research with Medicines of the University Clinical Hospital of Valencia on 8 October 2020 (order no. 2020/181). Participants are required to provide informed consent for the study and for the surgical procedure. All the data collected will be treated confidentially since they will be blinded and encrypted. The results from the trial will be published in international peer-reviewed scientific journals, regardless of whether these results are negative or inconclusive. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04850300).

Functional balance training in people with Parkinson's disease: a protocol of balanceHOME randomized control trial with crossover.

Introduction: Balance disturbances in Parkinson's Disease (PD) are usually assessed in a single-task as well as standard balance physiotherapy is carried out in isolated environments. Conversely, daily activities are developed in highly challenging environments. Although functional balance training (FBT) is included in the latest protocols, several methodological issues have not yet been considered. In the proposed single-blinded randomized control trial with crossover (NCT04963894), the aims are (1) to quantify the effects achieved by domiciliary FBT (balanceHOME program) in participants with and without cognitive impairment, and (2) to compare them with the effects of a passive-control period and a conventional face-to-face physiotherapy program for PD. Methods: The initial recruitment was estimated at 112 people with idiopathic PD. Two-thirds of the participants will be randomized to one of the two groups to make the crossover. In contrast, the other third will do a face-to-face group program only. The balanceHOME protocol consists of challenging balance exercises incorporated into functional daily tasks, developed in-home and conducted two times per week for 60-min over an 8-weeks period. The primary strategy will consist of splitting functional tasks of daily life into static and dynamic balance components, besides standardized facilitate and disturbing strategies to execution of each exercise. Biomechanics and clinical performance of balance and gait, perception of quality of life, cognitive and mental functioning, and severity of PD will be measured at baseline (T0), post-8 weeks training (T1), and follow-up (T2). Results: The primary outcome of the study will be the center of pressure sway area. The secondary outcomes consist of biomechanics and clinical variables related to static and dynamic balance. Outcomes from biomechanical of gait, quality of life, cognitive and mental state, and severity of PD, represent the tertiary outcomes. Discussion: The balanceHOME program standardizes the FBT in demanding and daily environments for people with PD who prefer individualized treatment from home. This is the first time that the effects of group versus individual balance rehabilitation have been compared in people with and without cognitive impairment and evaluated in complex environments. This still-to-be-finished study will open the possibility of new strategies according to changes in post-pandemic therapeutic approaches.

Women's Involvement in Steady Exercise (WISE): Study Protocol for a Randomized Controlled Trial.

BACKGROUND: Physical inactivity is a serious public health problem for people of all ages and is currently the fourth highest global risk factor for mortality. The transition period from adolescence to adulthood coincides with a marked reduction in participation in physical activity, with more than 50% (and up to 80%) of young adults stopping physical activity. This decrease in physical activity is more evident in women than in men. Despite efforts, existing programs face challenges in effectively initiating and maintaining physical activity among individuals, particularly women, for extended durations. To address these limitations, the Women's Involvement in Steady Exercise (WISE) randomized controlled trial (RCT) seeks to assess the efficacy of a digital high-intensity training intervention complemented by nutritional plans and other health-related advice. METHODS: The study will be a three-center, randomized (1:1), controlled, parallel-group trial with a six-month intervention period. A total of 300 participants will be recruited at three study sites in Spain, Serbia and Italy. The participants will be randomized to one of the two groups and will follow a six-month program. The primary outcome of the study is the daily step count. Self-reported physical activity, the adherence to the exercise program, body composition, physical activity enjoyment, quality of sleep and physical capacities will also be evaluated.

Relevance of Sociodemographics and Clinical Tests in Single- and Dual-Task Conditions as Gait Speed Predictors of Parkinson's Disease.

This cross-sectional study aimed to identify the patient characteristics and clinical test results that predict the functional gait speed of people with Parkinson's disease (PD). The impact of dual tasks on gait in Parkinson's disease (PD) reveals a lack of automaticity and increased cognitive demands. We explored which characteristics explained walking speed with and without dual-task interference and if they reflected the cognitive demands of the task. The preferred gait speed, stride length, and cadence were measured in individuals with PD through five conditions: single-task (ST) and visual, verbal, auditory, and motor dual-tasks (DTs). Sociodemographic and disease characteristics and the results from clinical tests such as the Dynamic Parkinson's Disease Gait Scale (DYPAGS), Frontal Assessment Battery (FAB), and Parkinson's Disease Questionnaire-39 (PDQ-39), among others, were also recorded. Two models of multiple regression analysis were used to explore the predictive value of outcomes concerning speed. In Model I, clinical results were included, and in Model II, spatiotemporal variables were added to the significant predictors of Model I. Forty PD patients (aged 66.72 (7.5) years) completed the assessments. All the models generated were significant (p < 0.01). Models I and II accounted for 47% and 93% of the variance, respectively, in the single-task condition. A patient's gender, prescribed medication (drugs), academic level, and Hoehn and Yahr (H&Y) stage, along with the FAB, DYPAGS, and PDQ-39 scores, were significant predictors of gait speed in Model I for the ST and DT conditions. In Model II, the H&Y stage and prescribed medication (drugs), along with the FAB and DYPAGS scores, remained significant predictors. This research found that sociodemographics, the patient's stage disease, and their clinical test results contribute to their walking speed, highlighting the multifactorial nature of gait in demanding environments.

Students' Perceptions of Instructional Rubrics in Neurological Physical Therapy and Their Effects on Students' Engagement and Course Satisfaction.

One of the main challenges faced by physical therapy (PT) students is to learn the practical skills involved in neurological physical therapy (PT). To help them to acquire these skills, a set of rubrics were designed for formative purposes. This paper presents the process followed in the creation of these rubrics and their application in the classroom, noting that students perceived them as valid, reliable, and highly useful for learning. The perception of the validity and usefulness of the rubrics has different closely related dimensions, showing homogeneous values across the students´ sociodemographic and educational variables, with the exception of dedication to studying, which showed a significant relationship with schoolwork engagement and course satisfaction. The adequacy of the hypothesized structural model of the relationships among the variables was confirmed. Direct effects of the perception of the rubrics' validity and engagement on course satisfaction were found, as well as direct effects of the assessment of the usefulness of the rubrics on schoolwork engagement and indirect effects on course satisfaction through this latter variable. The results are discussed taking into account the conclusions of previous research and different instructional implications.

Grip Strength, Neurocognition, and Social Functioning in People WithType-2 Diabetes Mellitus, Major Depressive Disorder, Bipolar Disorder, and Schizophrenia.

BACKGROUND: Frailty is a common syndrome among older adults and patients with several comorbidities. Grip strength (GS) is a representative parameter of frailty because it is a valid indicator of current and long-term physical conditions in the general population and patients with severe mental illnesses (SMIs). Physical and cognitive capacities of people with SMIs are usually impaired; however, their relationship with frailty or social functioning have not been studied to date. The current study aimed to determine if GS is a valid predictor of changes in cognitive performance and social functioning in patients with type-2 diabetes mellitus and SMIs. METHODS: Assessments of social functioning, cognitive performance, and GS (measured with an electronic dynamometer) were conducted in 30 outpatients with type 2 diabetes mellitus, 35 with major depressive disorder, 42 with bipolar disorder, 30 with schizophrenia, and 28 healthy controls, twice during 1-year, follow-up period. Descriptive analyses were conducted using a one-way analysis of variance for continuous variables and the chi-squared test for categorical variables. Differences between groups for the motor, cognitive, and social variables at T1 and T2 were assessed using a one-way analysis of covariance, with sex and age as co-variates (p < 0.01). To test the predictive capacity of GS at baseline to explain the variance in cognitive performance and social functioning at T2, a linear regression analysis was performed (p < 0.05). RESULTS: Predictive relationships were found among GS when implicated with clinical, cognitive, and social variables. These relationships explained changes in cognitive performance after one year of follow-up; the variability percentage was 67.7%, in patients with type-2 diabetes mellitus and 89.1% in patients with schizophrenia. Baseline GS along with other variables, also predicted changes in social functioning in major depressive disorder, bipolar disorder, and schizophrenia, with variability percentages of 67.3, 36, and 59%, respectively. CONCLUSION: GS combined with other variables significantly predicted changes in cognitive performance and social functioning in people with SMIs or type-2 diabetes mellitus. Interventions aimed to improve the overall physical conditions of patients who have poor GS could be a therapeutic option that confers positive effects on cognitive performance and social functioning.

Effects of Dual-Task Group Training on Gait, Cognitive Executive Function, and Quality of Life in People With Parkinson Disease: Results of Randomized Controlled DUALGAIT Trial.

OBJECTIVES: The aims of this study were to analyze the effects of a dual-task group program, to compare it with the effects of a single-task group program, and to analyze the effects of functional secondary tasks. DESIGN: Single-blind randomized controlled trial. SETTING: University laboratory and a rehabilitation gym at a health center. PARTICIPANTS: Patients (N=40) with a diagnosis of Parkinson disease (mean age, 66.72y; age range, 44-79y) with Hoehn and Yahr stage I to III who were on medication were randomized to either a group with dual-task training or a group with single-task training (only gait). INTERVENTION: Both interventions involved 20 sessions lasting 1 hour each and conducted twice a week. Dual-task training included walking exercises and cognitive or motor tasks carried out separately, then later performed together as a dual-task according to a progressive protocol in the same training session. MAIN OUTCOME MEASURES: Velocity and spatiotemporal parameters of gait were measured without a secondary task and during dual-task gait combined with a visual, verbal, auditory, and motor task. In addition, executive cognitive function and quality of life were measured. Assessments were conducted at baseline, postrehabilitation, and at the 8-week follow-up. RESULTS: The dual-task group demonstrated improved velocity and stride length time in all assessment conditions after training (P<.05), as well as perceived quality of life (P<.05). The single-task group experienced improvements in the same outcomes for only the motor condition (P<.05) after training, but failed to improve perceived quality of life (P>.05). Likewise, the dual-task group showed higher velocity and stride length after treatment than the single-task group across conditions. No significant changes were observed in cognitive performance (P>.05), although the dual-task group tended to improve performance during the executive function test. CONCLUSIONS: Dual-task training in functional contexts is associated with greater improvements in velocity and stride length in patients with PD compared with regular physiotherapy without secondary tasks. Dual-task training also improves perceived quality of life.

Motor and Cognitive Performance in Patients with Liver Cirrhosis with Minimal Hepatic Encephalopathy.

Minimal hepatic encephalopathy (MHE) is associated with mild cognitive impairment and frailty. This study aims to identify cognitive and motor differences in cirrhotic patients with and without MHE, and the correlations between motor signs and cognitive performance. Gait, balance, hand strength and motor speed performance were evaluated in 66 cirrhotic patients (38 without and 28 with MHE, according to the Psychometric Hepatic Encephalopathy Score (PHES). Cognitive performance was measured with the Mini-Mental State Examination, Verbal Fluency Test, Aprendizaje Verbal España-Complutense Test (TAVEC), Wechsler Adult Intelligence Scale III, Hamilton Depression and Anxiety Rating Scale and Functioning Assessment Short Test (FAST). MHE patients performed worse than patients without MHE in cognitive and autonomous functioning, learning and long-term memory, and verbal fluency. The same pattern was found in gait, center of pressure movement, variability of hand strength performance and hand motor speed. In MHE patients, high correlations were found between balance and FAST test, gait velocity and verbal skills, hand strength variability and anxiety and depression, and motor speed and FAST and TAVEC. MHE patients showed worse motor and cognitive performance than patients without MHE. MHE patients could have impaired movement control expressed as bradykinesia, and this reduced motor performance could correlate with cognitive performance.

Interference of functional dual-tasks on gait in untrained people with Parkinson's disease and healthy controls: a cross-sectional study.

BACKGROUND: In Parkinson's disease (PD) population, performing secondary tasks while walking further deteriorates gait and restrict mobility in functional contexts of daily life. This study (1) analyzed the interference of functional cognitive and motor secondary task on untrained people with PD and (2) compared their walking with healthy subjects. METHODS: Forty people with PD (aged 66.72 [7.5] years, Hoehn and Yahr stage I-II-III, on-medication) composed the PD group (PDG) and 43 participants (aged 66.60 [8.75] years) formed the group of healthy counterparts (HG). Gait was evaluated through spatiotemporal, kinematic and kinetic outcomes in five conditions: single task (ST) and visual, verbal, auditory and motor dual-task (DT). RESULTS: The velocity, stride length, and braking force performance of both groups was statistically higher in the ST condition than in verbal, auditory and motor DT (p < .05), and inferior in double support time and midstance force (p < .05). The same pattern was observed when compared the ST and visual DT condition, where participants showed a significantly higher stride length, double support time and braking force in the ST (p < .05). In addition, the PDG exhibited a significant shorter double support time and midstance force, and showed a higher braking force in the visual DT than in the verbal DT (p < .05). Similarly, the PDG showed a wider stride in the visual DT than in the motor DT condition (p < .05). PDG participants had a significantly lower performance than the HG in all the variables analyzed except for the maximum hip extension in the stance phase (p > .05). CONCLUSIONS: In untrained participants with PD, verbal and motor secondary tasks affect gait significantly, while auditory and visual tasks interfere to a lesser extent. Untrained people with PD have a poorer gait performance than their healthy counterparts, but in different grades according to the analyzed variables. TRIAL REGISTRATION: The data in this paper are part of a single-blind, randomized, controlled trial and correspond to the evaluations performed before a physical rehabilitation program, retrospectively registered with the number at clinicaltrial.govNCT04038866.