A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials.

Background: Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and reporting surrogate endpoints in trials. Methods: As part of developing the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) extensions for randomised trials reporting surrogate endpoints, we undertook a scoping review, e-Delphi study, consensus meeting, and a web survey to examine current definitions and stakeholder (including clinicians, trial investigators, patients and public partners, journal editors, and health technology experts) interpretations of surrogate endpoints as primary outcome measures in trials. Findings: Current surrogate endpoint definitional frameworks are inconsistent and unclear. Surrogate endpoints are used in trials as a substitute of the treatment effects of an intervention on the target outcome(s) of ultimate interest, events measuring how patients feel, function, or survive. Traditionally the consideration of surrogate endpoints in trials has focused on biomarkers (e.g., HDL cholesterol, blood pressure, tumour response), especially in the medical product regulatory setting. Nevertheless, the concept of surrogacy in trials is potentially broader. Intermediate outcomes that include a measure of function or symptoms (e.g., angina frequency, exercise tolerance) can also be used as substitute for target outcomes (e.g., all-cause mortality)-thereby acting as surrogate endpoints. However, we found a lack of consensus among stakeholders on accepting and interpreting intermediate outcomes in trials as surrogate endpoints or target outcomes. In our assessment, patients and health technology assessment experts appeared more likely to consider intermediate outcomes to be surrogate endpoints than clinicians and regulators. Interpretation: There is an urgent need for better understanding and reporting on the use of surrogate endpoints, especially in the setting of interventional trials. We provide a framework for the definition of surrogate endpoints (biomarkers and intermediate outcomes) and target outcomes in trials to improve future reporting and aid stakeholders' interpretation and use of trial surrogate endpoint evidence. Funding: SPIRIT-SURROGATE/CONSORT-SURROGATE project is Medical Research Council Better Research Better Health (MR/V038400/1) funded.

Effects of mental practice on mobility of individuals in the early subacute post-stroke phase: A randomized controlled clinical trial.

INTRODUCTION: Only a small number of clinical trials were designed to investigate Mental Practice (MP)'s use for gait rehabilitation in individuals in the early subacute post-stroke phase. This trial aims to investigate the effect of mental practice on mobility rehabilitation in the early subacute phase after a stroke in comparison to a control group. METHODS: Randomized controlled clinical trial with 16 individuals diagnosed with a stroke between 50 and 80 years of age. Mobility was evaluated using Timed Up and Go and the Five-Minute Walk Test. In addition, lower extremity muscular strength, Timed Up and Go Assessment of Biomechanical Strategies, quality of life, and depression were evaluated. RESULTS: Before and after intervention (within-subjects), mental practice group showed improved mobility in Timed Up and Go (p = 0.01,r = 0.59), muscular strength for bending the right hip (p = 0.04, r = 0.50), for right knee bending (p = 0.03,r = 0.53), and in biomechanical performance of Timed Up and Go Assessment of Biomechanical Strategies(p = 0.01,r = 0.63). Control group showed improvement in neither mobility nor in muscular strength after intervention. Comparing the scores between the groups after intervention (between-subjects), no differences were found for any of the study's outcomes. In the analysis of deltas (gains), it was observed that mental practice group volunteers had a reduction in Timed Up and Go (p = 0.27,r = 0.29) and an increase in total Timed Up and Go Assessment of Biomechanical Strategies scores (p = 0.14,r = 0.36). CONCLUSION: Mental Practice was not associated with mobility, muscular strength, mental health, and quality of life improvement for patients in the early subacute post-stroke phase as compared to a control group.

Fall Efficacy Scale-International cut-off score discriminates fallers and non-fallers individuals who have had stroke.

BACKGROUND: Falls, which are common events after stroke, may lead to activity limitations and increased dependence. It is important to identify which commonly employed clinical measures could differentiate individuals, who are fallers from the non-fallers. AIM: To investigate specific cut-off values of clinical measures that could discriminate fallers and non-fallers individuals with chronic stroke. METHOD: This cross-sectional study involved 105 community-dwelling individuals with stroke. The primary outcome was report of falls over the last six months. The clinical predictors included measures of mobility (walking speed, stair ascent/descent cadences, time to perform the Timed Up and Go test, and ABILOCO) and the Fall Efficacy Scale - International (FES-I) scores. To identify which measures were able to detect between-group differences, independent Student's t-tests were employed. For measures which were able to discriminate fallers from the non-fallers, the Receiver Operating Characteristics (ROC) and the Area Under the ROC Curve (AUC) were calculated. RESULTS: Out of the 105 participants (61 men), 41% reported falls over the previous 6 months. Stair ascent cadence, ABILOCO, and FES-I scores significantly differentiated the groups, but only the FES-I demonstrated acceptable discriminatory ability (AUC = 0.71). The optimal FES-I cut-off score was 28 points (sensitivity = 0.71; specificity = 0.57; positive predictive value = 51%; and negative predictive value = 74%). CONCLUSIONS: The FES-I demonstrated good discriminatory ability to classify individuals with chronic stroke, who were fallers from the non-fallers. The use of the established cut-off value of 28 points is recommended and may help clinical reasoning and decision-making in stroke rehabilitation.

Incidence and potential predictors of early onset of upper-limb contractures after stroke.

OBJECTIVES: To investigate the incidence and potential predictors of upper-limb contractures, three months after stroke. DESIGN: Prospective cohort study. METHODS: Consecutive sample of individuals with hemiparesis due to stroke, admitted to a public hospital in Brazil. Contractures were measured by passive range of motion of lateral shoulder rotation, elbow extension, and wrist extension with a gravity inclinometer. Potential predictors included measures of muscle strength, spasticity of the upper-limb muscles, upper-limb function, dexterity, and pain. Measurements were obtained within four weeks and at three months after the stroke. A binomial regression analysis was employed. RESULTS: Out of the 76 individuals with hemiparesis, 28% developed at least one contracture on their paretic upper limb. The incidence of contracture varied across the joints from 6% to 16% and the wrist was the most affected joint. Individuals with moderate stroke showed higher incidence of contracture, compared with those with mild stroke. Dexterity (OR 0.009, 95% confidence intervals (95% CI) 0.00-0.19) and pain (OR 6.417, 95% CI 1.22-33.83) were significant predictors of shoulder, elbow, and wrist contractures. CONCLUSIONS: Individuals with mild and moderate stroke developed upper-limb contractures three months after the onset of the stroke, with an incidence of 28%. The predictors were the presence of pain and loss of dexterity. These impairments should be earlier targeted during rehabilitation interventions.Implications for rehabilitationThe incidence of upper limb contracture 3 months after the stroke is high after mild to moderate stroke.Wrist contractures are the most common upper limb contracture.The presence of pain and loss of dexterity significantly contribute to the development of upper limb contractures.Health professionals should target on the control of pain and improvement of upper-limb dexterity to prevent contractures.

Associations between walking speed and participation, according to walking status in individuals with chronic stroke.

BACKGROUND: Reduced walking speed (WS) may lead to restrictions in participation of individuals with stroke, however, the relationships between WS and participation still need to better clarified. OBJECTIVE: To evaluate the relationships between WS and participation and compare the levels of participation of individuals with chronic stroke, who were stratified according to their walking status. METHODS: One-hundred and five individuals with stroke (58±12 years; 61 men) participated. WS was measured by the 10-meter walking test and reported in m/s. The participants were stratified into three walking status groups: household (WS <0.4 m/s), limited-community (0.4 m/s-0.8 m/s), and full-community ambulation (>0.8 m/s). Participation was assessed by the Brazilian version of the Assessment of Life Habits 3.1 (LIFE-H 3.1-Brazil). RESULTS: Between-group analyses revealed statistically significant differences between the household, limited-community, and full-community ambulators regarding the LIFE-H 3.1 total (F = 17.5; p < 0.0001), as well the daily activity (F = 12.3; p < 0.0001) and social role (F = 19.0; p < 0.0001) domain scores. Measures of WS were correlated with the daily activity (r = 0.50, p < 0.0001), social role (r = 0.53, p < 0.0001), total LIFE-H scores (r = 0.53, p < 0.0001), and most of the LIFE-H categories (r = 0.23-0.56). CONCLUSIONS: WS was significantly correlated with participation and was able to distinguish between individuals with stroke, who had different levels of participation.

Validity and reliability of the Modified Sphygmomanometer Test with fixed stabilization for clinical measurement of muscle strength.

OBJECTIVE: To investigate the concurrent validity of the Modified Sphygmomanometer Test (MST) with fixed stabilization, compared to the portable dynamometer, and to verify its test-retest and inter-raterreliability. METHODS: Methodological study. The muscle strength of the following groups was measured: flexors and extensors of the wrist, of the hip, and of the knee and plantar flexors. The Tycos® aneroid sphygmomanometer and the Microfet 2® dynamometer were used. Stabilization was performed using the Mullingan® belt. Descriptive statistics were performed for characterization of the sample. To determine the validity of the MST with fixed stabilization, comparing it with the portable dynamometer, we investigated the correlation between the measurements obtained with the two instruments using the Pearson correlation coefficient. Intraclass Correlation Coefficient (ICC) was used to investigate inter-examiner and test-retest reliability (α = 0.05). RESULTS: 59 individuals were included (1176 evaluations). A statistically significant correlation of moderate to high magnitude (0.58 ≤ r ≤ 0.81) was observed for concurrent validity of the MST with fixed stabilization versus the portable dynamometer for all muscle groups. Regarding inter-rater reliability, it was observed statistically significant ICC considered excellent to good (0.72 ≤ r ≤ 0.94) for all muscle groups. Regarding test-retest reliability, first evaluator presented good to excellent ICC (0.64 ≤ r ≤ 0.94), while second evaluator presented good to excellent ICC (0.74 ≤ r ≤ 0.96) for all muscle groups. CONCLUSION: The MST with fixed stabilization is valid and reliable for clinical measurement of muscle strength and can overcome previous limitations reported in the literature.

Activity Monitor Placed at the Nonparetic Ankle Is Accurate in Measuring Step Counts During Community Walking in Poststroke Individuals: A Validation Study.

BACKGROUND: Different environmental factors may affect the accuracy of step-count activity monitors (AM). However, the validation conditions for AM accuracy largely differ from ecological environments. OBJECTIVES: To assess and compare the accuracy of AM in counting steps among poststroke individuals: during different locomotor tasks, with AM placed at the nonparetic ankle or hip, and when walking in a laboratory or inside a mall. DESIGN: Validation study. SETTINGS: Laboratory and community settings. PARTICIPANTS: Twenty persons with chronic hemiparesis, independent walkers. METHODS: First session: participants performed level walking (6-minute walk test [6MWT]), ramps, and stairs in the laboratory with AM placed at the nonparetic ankle and hip. Second session: participants walked a mall circuit, including the three tasks, with AM placed at the nonparetic ankle. The sessions were video recorded. MAIN OUTCOME MEASUREMENTS: Absolute difference between the steps counted by AM and the steps viewed on the video recordings (errors, %); occurrence of errors greater than 10%. RESULTS: Median errors were similar for the 6MWT (0.86 [0.22, 7.70]%), ramps (2.17 [0.89, 9.61]%), and stairs (8.33 [2.65, 19.22]%) with AM at the ankle. Step-count error was lower when AM was placed at the ankle (8.33 [2.65, 19.22]%) than at the hip (9.26 [3.25, 42.63]%, P = .03). The greatest errors were observed among the slowest participants (≤0.4 m/s) on ramps and stairs, whereas some faster participants (>1 m/s) experienced the greatest error during the 6MWT. Median error was slightly increased in the mall circuit (2.67 [0.61, 12.54]%) compared with the 6MWT (0.50 [0.24, 6.79]%, P = .04), with more participants showing errors >10% during the circuit (7 vs 2, P = .05). CONCLUSIONS: Step counts are accurately measured with AM placed at the nonparetic ankle in laboratory and community settings. Accuracy can be altered by stairs and ramps among the slowest walkers and by prolonged walking tasks among faster walkers. LEVEL OF EVIDENCE: III.

Validity of the accelerometer and smartphone application in estimating energy expenditure in individuals with chronic stroke.

OBJECTIVE: To examine the concurrent validity of the GT3X® ActiGraph accelerometer and Google Fit® smartphone application in estimating energy expenditure in people who had suffered a stroke, during fast overground walking. METHODS: Thirty community-dwelling stroke individuals walked on a 10-meter hallway over 5min at their fastest speeds, wearing a Cortex Metamax 3B® ergoespirometer, a GT3X® ActiGraph accelerometer, and a smartphone with the Google Fit® application. Pearson correlation coefficients were calculated to verify the associations between measures of energy expenditure, in kilocalories (kcal), estimated by both devices and those obtained with the Cortex Metamax 3B® ergoespirometer (gold-standard measure). RESULTS: Fair association was found between the energy expenditure values estimated from the combined formula of the ActiGraph GT3X® and those obtained with the gold-standard measure (r=0.37; p=0.04). No significant associations were found between the energy expenditure values estimated by the Google Fit® application and those provided by the gold-standard measure. CONCLUSIONS: The findings demonstrated that both the GT3X®ActiGraph accelerometer and the Google Fit® smartphone application do not provide valid measures of energy expenditure in chronic stroke individuals during fast overground walking.

Are functional mobility tests responsive to group physical therapy intervention in individuals with Parkinson's disease?

BACKGROUND: The Timed up and go test (TUG), the Five times sit-to-stand test (FTSTS) and the Bed Mobility test (BMT) are widely used in clinical practice for Parkinson Disease (PD). However, no reported studies have evaluated the responsiveness to group physical therapy intervention (GPTI). OBJECTIVE: To verify if TUG, FTSTS and BMT were responsive to GPTI. METHODS: Thirty individuals with PD were assessed prior to and after an 8-week evidence-based GPTI. Paired t test was used to determine statistically significant change pre-and post-intervention. Internal responsiveness (IR) was classified with the standardized response mean (SRM). A 5-point Likert scale assessed self-perceived performance by the subjects after the intervention. Analysis of the receiver operating characteristic (ROC) curve was used to determine the accuracy and cut-off scores for identifying participants who had shown improvement. RESULTS: GPTI was efficient in improving real (p≤0.001) and self-perceived mobility performance in all measures. All tests were responsive to changes: the IR varied from medium to high (SRM = 0.7-1.5); the cut-off point for TUG test was >2.2 s, for FTSTS test was >2.5 s and for BM test >1.4 s. CONCLUSIONS: The TUG, FTSTS and BMT were responsive to the GPTI and accurately detected meaningful clinical changes. Our results provide an important information about the clinical application of these tests in PD individuals.

Performance and capacity-based measures of locomotion, compared to impairment-based measures, best predicted participation in individuals with hemiparesis due to stroke.

PURPOSE: To determine the potential predictors of participation of individuals with post-stroke hemiparesis, taking into account modifiable variables of impairments, activity limitations, and environmental factors. METHODS: One hundred and nine individuals (58 ± 12 years; 64 men) participated in this study. Outcomes included measures of impairments (depressive symptoms: Geriatric Depression Scale and motor-based impairments: finger-to-nose test, lower extremity (LE) motor coordination test, and handgrip strength, isometric strength of the LE muscles), activity (capacity: 10-meter walking speed test and Test d'Évaluation des Membres Supérieurs de Personnes Agées; performance: locomotion and manual abilities; environmental factors (Measure of the Quality of the Environment); and participation: Assessment of Life Habits (LIFE-H 3.1 Brazil)). RESULTS: Regression analyses revealed that the explanatory variables accounted for 59% and 49% of the variance in the LIFE-H 3.1 Brazil daily activity and social role sub-scales, respectively. Locomotion performance (R2 = 39%; p < 0.0001) and walking speed (R2 = 32%; p < 0.0001) were the best predictors of the LIFE-H 3.1 Brazil daily activity and social role sub-scales, respectively. Depressive symptoms were the only impairments, which were retained in both models. CONCLUSIONS: Performance and capacity-based measures of locomotion showed to be the best predictors of participation. Additionally, depressive symptoms should not be underlooked. Implications for Rehabilitation Activity-related measures of locomotion showed to be the main predictors of participation in individuals with post-stroke hemiparesis, as assessed by the daily activity and social role sub-scales of the LIFE-H 3.1. The daily activity model was best predicted by measures of performance, whereas the social role sub-scale, by measures of capacity. Although small, the impact of depressive symptoms on participation should not be underlooked. Locomotion appeared to be essential for participation and increases in walking speed and locomotion ability should be the main goals for both professionals and individuals, when the aim is to increase participation.

Assessing Timed Up and Go in Parkinson's disease: Reliability and validity of Timed Up and Go Assessment of biomechanical strategies.

OBJECTIVE: To investigate the measurement properties of the Timed Up and Go Assessment of Biomechanical Strategies (TUG-ABS) to determine its adequacy for use with individuals with Parkinson's disease. SUBJECTS: Fifty individuals with Parkinson's disease. DESIGN: Diagnostic accuracy. METHODS: The study investigated the following properties: reliability (inter-examiner, intra-examiner, test-retest, internal consistency and minimal detectable change), construct validity, and floor and ceiling effect. RESULTS: Considering the total score, the inter-examiner, test-retest and intra-examiner reliabilities were classified as excellent (0.95 ≤ intra-class correlation coefficient (ICC)≤0.99). The TUG-ABS presented excellent internal consistency (α = 0.98). The minimal detectable change was 3.82 points. The construct validity between the TUG-ABS and the Unified Parkinson's Disease Rating Scale (UPDRS) - part III was classified as moderate (ρ = -0.62). Significant, elevated and positive correlations were obtained between TUG-ABS and the Balance Evaluation System Test (BESTest)-VI (ρ = 0.72) and negative correlations between TUG-ABS and TUG (ρ = -0.78). The discriminant function obtained with the total score of TUG-ABS classified 60% of the individuals correctly with respect to the group (determined by the performance in TUG) to which they belonged. One-way analysis of variance (ANOVA) showed that TUG-ABS discriminated the individuals with Parkinson's disease in all stages according to Hoehn & Yahr. There was a ceiling effect of 22%. CONCLUSION: TUG-ABS presented adequate measurement properties in individuals with Parkinson's disease.

Lower-limb motor coordination is significantly impaired in ambulatory people with chronic stroke: A cross-sectional study.

OBJECTIVES: To establish the deficits of motor coordination of the lower limbs after stroke, in comparison with healthy controls, and to investigate whether the magnitude of the deficits would be influenced by the levels of motor recovery. DESIGN: Cross-sectional study. SUBJECTS: Chronic stroke patients and healthy subjects. METHODS: Lower-limb motor coordination of both stroke and healthy volunteers was measured using the Lower Extremity Motor Coordination Test (LEMOCOT). The motor coordination deficits of the participants with stroke were analysed all together and separated, according to their levels of motor recovery, measured using the Fugl-Meyer lower-limb motor section scores. RESULTS: Ninety-seven individuals with chronic stroke, 55 men, mean age 58 years, were evaluated. Motor coordination was significantly impaired on both paretic (mean: -22 touches; 95% confidence interval (95% CI) -24 to -19; deficit: 61%) and non-paretic (mean -6 touches; 95% CI -8 to -4; deficit: 17%) lower limbs. Significant differences in the LEMOCOT scores were found between the levels of motor recovery (p < 0.01), except between the participants with marked and moderate impairments. CONCLUSION: Motor coordination of the lower limbs is significantly impaired after stroke, but the deficits of the non-paretic lower limb (17%) appear not to be clinically relevant. These findings suggest that interventions prescribed to improve motor coordination after stroke should focus on the paretic lower limb and/or include bilateral activities.

Efficacy of interventions to improve physical activity levels in individuals with stroke: a systematic review protocol.

INTRODUCTION: Stroke is a leading health problem worldwide and an important cause of disability. Stroke survivors show low levels of physical activity, and increases in physical activity levels may improve function and health status. Therefore, the aims are to identify which interventions that have been employed to increase physical activity levels with stroke survivors, to verify their efficacy and to identify the gaps in the literature. METHODS AND ANALYSIS: A systematic review of randomised controlled trials that investigated the efficacy of interventions aiming at increasing physical activity levels of stroke survivors will be conducted. Electronic searches will be performed in the MEDLINE, Physiotherapy Evidence Database (PEDro), Excerpta Medica (EMBASE), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) and Scientific Electronic Library Online (SCIELO) databases. Hand searches of the reference lists of the included studies or relevant reviews will also be employed. Two independent reviewers will screen all the retrieved titles, abstracts and full texts. A third reviewer will be referred to solve any disagreements. The quality of the included studies will be assessed by the PEDro Rating Scale. This systematic review will also include a qualitative synthesis. Meta-analyses will be performed, if the studies are sufficiently homogeneous. This review will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement. The quality of the evidence regarding physical activity will be assessed, according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE). DISCUSSION: This systematic review will provide information on which interventions are effective for increasing physical activity levels of stroke survivors. This evidence may be important for clinical decision-making and will allow the identification of gaps in the literature that may be useful for the definition of future research goals and the planning of new trials. TRIAL REGISTRATION NUMBER: CRD42016037750.

Strength deficits of the paretic lower extremity muscles were the impairment variables that best explained restrictions in participation after stroke.

PURPOSE: To evaluate which measures of physical impairments of both upper extremity (UE) and lower extremity (LE) would predict restrictions in participation with 105 community-dwelling stroke subjects. METHODS: For this cross-sectional, exploratory study, participation was assessed by the daily activity and social role domains of the Assessment of Life Habits (LIFE-H). The potential predictors included measures of physical impairments (UE and LE motor recovery, sensation, motor coordination, and strength deficits). RESULTS: Step-wise multiple linear regression analyses revealed that, for the daily activity domain, LE strength deficits and UE motor recovery explained 28% of the variance in the LIFE-H scores and LE strength deficits alone explained 22% (F = 29.5; p< .0001). For the social role domain, LE strength deficits and sensation explained 22% of the variance in the LIFE-H scores and LE strength deficits alone explained 16% (F = 20.6; p< .0001). CONCLUSIONS: Strength deficits of the LE muscles were the physical impairment variables that best predicted participation in both daily activity and social role domains of the LIFE-H. Although significant, UE motor recovery and LE sensation added little to the explained variance. Future research is needed to determine whether progressive resistance strength training program enhances participation after stroke. Implications for Rehabilitation Residual strength deficits of the LE muscles were the physical impairments that showed to be the main predictors of restrictions in participation, as determined by the daily activity and social role domains of the LIFE-H 3.1. It is possible that stroke individuals would benefit from physical interventions aiming at improving the strength of the LE muscles, when the goal is to enhance participation.

Dynamometry for the measurement of grip, pinch, and trunk muscles strength in subjects with subacute stroke: reliability and different number of trials

ABSTRACT Background Muscle strength is usually measured in individuals with stroke with Portable dynamometers (gold standard). However, no studies have investigated the reliability, the standard error of measurement (SEM) and the minimal detectable difference (MDD95%) of the dynamometry for the measurement of hand grip, pinch grip and trunk strength in subjects with subacute stroke. Objective 1) To investigate the intra and inter-rater reliability, the SEM and the MDD95% of the portable dynamometers for the measurement of grip, pinch and trunk strength in subjects with subacute stroke, and 2) to verify whether the use of different number of trials (first trial and the average of the first two and three trials) affected the results. Method 32 subjects with subacute stroke (time since stroke onset: 3.6 months, SD=0.66 months) were evaluated. Hand grip, 3 pinch grips (i.e. pulp-to-pulp/palmar/lateral) and 4 trunk muscles (i.e. flexors, extensors, lateral flexors and rotators) strength were bilaterally assessed (except trunk flexors/extensors) with portable dynamometry by two independent examiners over two sessions (1-2 weeks apart). One-way ANOVAs and intraclass correlation coefficients (ICC2,k) were used for analysis (α=0.05). SEM and MDD95% were also calculated. Results For all muscular groups and sources of outcome values, including one trial, after familiarization, similar results were found (0.01≤F≤0.08; 0.92≤p≤0.99) with significant and adequate values of intra-rater (0.64≤ICC≤0.99; 0.23≤95%CI≤0.99) and inter-rater (0.66≤ICC≤0.99; 0.25≤95%CI≤0.99) reliability. SEM and MDD95% were considered low (0.39≤EPM≤2.21 Kg; 0.96≤MMD95%≤6.12 Kg) for all outcome scores. Conclusion Only one trial, following familiarization, demonstrated adequate intra-rater and inter-rater reliability of the portable dynamometers for the measurement of hand grip, pinch grip and trunk strength in subjects with subacute stroke.

Health, function and disability in stroke patients in the community.

BACKGROUND: Stroke patients commonly have impairments associated with reduction in functionality. Among these impairments, the motor impairments are the most prevalent. The functional profile of these patients living in the community who are users of the primary health-care services in Brazil has not yet been established. OBJECTIVE: To describe the functional profile of stroke patients who are users of the primary health-care services in Brazil, looking at one health-care unit in the city of Belo Horizonte, Brazil. METHOD: From medical records and home visits, data were collected regarding health status, assistance received following the stroke, personal and environmental contextual factors, function and disability, organized according to the conceptual framework of the International Classification of Functioning, Disability and Health (ICF). Test and instruments commonly applied in the assessment of stroke patients were used. RESULTS: Demographic data from all stroke patients who were users of the health-care unit (n=44, age: 69.23±13.12 years and 67±66.52 months since the stroke) participated of this study. Most subjects presented with disabilities, as changes in emotional function, muscle strength, and mobility, risks of falling during functional activities, negative self-perception of quality of life, and perception of the environment factors were perceived as obstacles. The majority of the patients used the health-care unit to renew drug prescriptions, and did not receive any information on stroke from health professionals, even though patients believed it was important for patients to receive information and to provide clarifications. CONCLUSION: Stroke patients who used primary health-care services in Brazil have chronic disabilities and health needs that require continuous health attention from rehabilitation professionals. All of these health needs should be considered by health professionals to provide better management as part of the integral care of stroke patients, as recommended by the clinical practice guidelines for stroke rehabilitation.

Health, function and disability in stroke patients in the community

ABSTRACT Background Stroke patients commonly have impairments associated with reduction in functionality. Among these impairments, the motor impairments are the most prevalent. The functional profile of these patients living in the community who are users of the primary health-care services in Brazil has not yet been established Objective To describe the functional profile of stroke patients who are users of the primary health-care services in Brazil, looking at one health-care unit in the city of Belo Horizonte, Brazil. Method From medical records and home visits, data were collected regarding health status, assistance received following the stroke, personal and environmental contextual factors, function and disability, organized according to the conceptual framework of the International Classification of Functioning, Disability and Health (ICF). Test and instruments commonly applied in the assessment of stroke patients were used. Results Demographic data from all stroke patients who were users of the health-care unit (n=44, age: 69.23±13.12 years and 67±66.52 months since the stroke) participated of this study. Most subjects presented with disabilities, as changes in emotional function, muscle strength, and mobility, risks of falling during functional activities, negative self-perception of quality of life, and perception of the environment factors were perceived as obstacles. The majority of the patients used the health-care unit to renew drug prescriptions, and did not receive any information on stroke from health professionals, even though patients believed it was important for patients to receive information and to provide clarifications. Conclusion Stroke patients who used primary health-care services in Brazil have chronic disabilities and health needs that require continuous health attention from rehabilitation professionals. All of these health needs should be considered by health professionals to provide better management as part of the integral care of stroke patients, as recommended by the clinical practice guidelines for stroke rehabilitation.

Dynamometry for the measurement of grip, pinch, and trunk muscles strength in subjects with subacute stroke: reliability and different number of trials.

BACKGROUND: Muscle strength is usually measured in individuals with stroke with Portable dynamometers (gold standard). However, no studies have investigated the reliability, the standard error of measurement (SEM) and the minimal detectable difference (MDD95%) of the dynamometry for the measurement of hand grip, pinch grip and trunk strength in subjects with subacute stroke. OBJECTIVE: 1) To investigate the intra and inter-rater reliability, the SEM and the MDD95% of the portable dynamometers for the measurement of grip, pinch and trunk strength in subjects with subacute stroke, and 2) to verify whether the use of different number of trials (first trial and the average of the first two and three trials) affected the results. METHOD: 32 subjects with subacute stroke (time since stroke onset: 3.6 months, SD=0.66 months) were evaluated. Hand grip, 3 pinch grips (i.e. pulp-to-pulp/palmar/lateral) and 4 trunk muscles (i.e. flexors, extensors, lateral flexors and rotators) strength were bilaterally assessed (except trunk flexors/extensors) with portable dynamometry by two independent examiners over two sessions (1-2 weeks apart). One-way ANOVAs and intraclass correlation coefficients (ICC2,k) were used for analysis (α=0.05). SEM and MDD95% were also calculated. RESULTS: For all muscular groups and sources of outcome values, including one trial, after familiarization, similar results were found (0.01≤F≤0.08; 0.92≤p≤0.99) with significant and adequate values of intra-rater (0.64≤ICC≤0.99; 0.23≤95%CI≤0.99) and inter-rater (0.66≤ICC≤0.99; 0.25≤95%CI≤0.99) reliability. SEM and MDD95% were considered low (0.39≤EPM≤2.21 Kg; 0.96≤MMD95%≤6.12 Kg) for all outcome scores. CONCLUSION: Only one trial, following familiarization, demonstrated adequate intra-rater and inter-rater reliability of the portable dynamometers for the measurement of hand grip, pinch grip and trunk strength in subjects with subacute stroke.

Assessment of grip strength with the modified sphygmomanometer test: association between upper limb global strength and motor function.

BACKGROUND: Grip strength, commonly evaluated with the handgrip dynamometer, is a good indicator of upper limb (UL) function in stroke subjects and may reflect the global strength deficits of the whole paretic UL. The Modified Sphygmomanometer Test (MST) also provides objective and adequate measures at low-cost. OBJECTIVE: To assess whether grip strength values obtained by using the MST and those obtained by using a handgrip dynamometer would present similar correlations with the global strength and motor function of the paretic UL in subjects with stroke, both in the subacute and chronic phases. METHOD: Measures of grip strength (MST and handgrip dynamometer), UL global strength (MST and hand-held dynamometer), and UL motor function (Fugl-Meyer motor assessment scale) were obtained with 33 subacute and 44 chronic stroke subjects. Pearson and Spearman correlation coefficients were calculated and Stepwise multiple regression analyses were performed to investigate predictor variables of grip strength (α=0.05). RESULTS: Significant correlations of similar magnitude were found between measures of global strength of the paretic UL and grip strength assessed with both the MST (0.66≤r≤0.78) and handgrip dynamometer (0.66≤r≤0.78) and between UL motor function and grip strength assessed with both the MST (0.50≤rs≤0.51) and hand-held dynamometer (0.50≤rs≤0.63) in subacute and chronic stroke subjects. Only global strength remained as a significant predictor variable of grip strength for the MST (0.43≤R2≤0.61) and for the handgrip dynamometer (0.44≤R2≤0.61) for both stroke subgroups. CONCLUSION: Grip strength assessed with the MST could be used to report paretic UL global strength.

Assessment of grip strength with the modified sphygmomanometer test: association between upper limb global strength and motor function

ABSTRACT Background: Grip strength, commonly evaluated with the handgrip dynamometer, is a good indicator of upper limb (UL) function in stroke subjects and may reflect the global strength deficits of the whole paretic UL. The Modified Sphygmomanometer Test (MST) also provides objective and adequate measures at low-cost. Objective: To assess whether grip strength values obtained by using the MST and those obtained by using a handgrip dynamometer would present similar correlations with the global strength and motor function of the paretic UL in subjects with stroke, both in the subacute and chronic phases. Method: Measures of grip strength (MST and handgrip dynamometer), UL global strength (MST and hand-held dynamometer), and UL motor function (Fugl-Meyer motor assessment scale) were obtained with 33 subacute and 44 chronic stroke subjects. Pearson and Spearman correlation coefficients were calculated and Stepwise multiple regression analyses were performed to investigate predictor variables of grip strength (α=0.05). Results: Significant correlations of similar magnitude were found between measures of global strength of the paretic UL and grip strength assessed with both the MST (0.66≤r≤0.78) and handgrip dynamometer (0.66≤r≤0.78) and between UL motor function and grip strength assessed with both the MST (0.50≤rs≤0.51) and hand-held dynamometer (0.50≤rs≤0.63) in subacute and chronic stroke subjects. Only global strength remained as a significant predictor variable of grip strength for the MST (0.43≤R2≤0.61) and for the handgrip dynamometer (0.44≤R2≤0.61) for both stroke subgroups. Conclusion: Grip strength assessed with the MST could be used to report paretic UL global strength.