28 research outputs found

    Inter-rater reliability, sensitivity to change and responsiveness of the orthopaedic Wolf-Motor-Function-Test as functional capacity measure before and after rehabilitation in patients with proximal humeral fractures

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    Background: The incidence of proximal humeral fractures (PHF) increased by more than 30% over the last decade, which is accompanied by an increased number of operations. However, the evidence on operative vs. non-operative treatment and post-operative treatments is limited and mostly based on expert opinion. It is mandatory to objectively assess functional capacity to compare different treatments. Clinical tools should be valid, reliable and sensitive to change assessing functional capacity after PHFs. This study aimed to analyse inter-rater reliability of the videotaped Wolf-Motor-Function-Test-Orthopaedic (WMFT-O) and the association between the clinical WMFT-O and the Disability of the Arm, Shoulder and Hand (DASH) and to determine the sensitivity to change of the WMFT-O and the DASH to measure functional capacity before and after rehabilitation in PHF patients. Methods: Fifty-six patients (61.7 ± 14.7 years) after surgical treatment of PHF were assessed using the WMFT-O at two different time points. To determine inter-rater reliability, the videotaped WMFT-O was evaluated through three blinded raters. Inter-rater agreement was determined by Fleiss’ Kappa statistics. Pearson correlation coefficients were calculated to assess the association between the clinical WMFT-O and the video rating as well as the DASH. Sensitivity to change and responsiveness were analysed for the WMFT-O and the DASH in a subsample of forty patients (53.8 ± 1.4 years) who were assessed before and after a three week robotic-assisted training intervention. Results: Inter-rater agreement was indicated by Fleiss’ Kappa values ranging from 0.33–0.66 for functional capacity and from 0.27–0.54 for quality of movement. The correlation between the clinical WMFT-O and the video rating was higher than 0.77. The correlation between the clinical WMFT-O and the DASH was weak. Sensitivity to change was high for the WMFT-O and the DASH and responsiveness was given. In comparison to the DASH, the sensitivity to change of the WMFT-O was higher. Conclusion: The overall results indicate that the WMFT-O is a reliable, sensitive and responsive instrument to measure more objectively functional change over time in rehabilitation after PHF. Furthermore, it has been shown that video assessment is eligible for studies to ensure a full blinding of raters. Trial registration: Clinicaltrials.gov, NCT03100201. Registered on 28 March 2017. The trial was retrospectively registered

    Concurrent validity and reliability of the Community Balance and Mobility scale in young-older adults

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    Background: With the growing number of young-older adults (baby-boomers), there is an increasing demand for assessment tools specific for this population, which are able to detect subtle balance and mobility deficits. Various balance and mobility tests already exist, but suffer from ceiling effects in higher functioning older adults. A reliable and valid challenging balance and mobility test is critical to determine a young-older adult’s balance and mobility performance and to timely initiate preventive interventions. The aim was to evaluate the concurrent validity, inter- and intrarater reliability, internal consistency, and ceiling effects of a challenging balance and mobility scale, the Community Balance and Mobility Scale (CBM), in young-older adults aged 60 to 70 years. Methods: Fifty-one participants aged 66.4 ± 2.7 years (range, 60–70 years) were assessed with the CBM. The Fullerton Advanced Balance scale (FAB), 3-Meter Tandem Walk (3MTW), 8-level balance scale, Timed-Up-and-Go (TUG), and 7-m habitual gait speed were used to estimate concurrent validity, examined by Spearman correlation coefficient (ρ). Inter- and intrarater reliability were calculated as Intra-class-correlations (ICC), and internal consistency by Cronbach alpha and item-total correlations (ρ). Ceiling effects were determined by obtaining the percentage of participants reaching the highest possible score. Results: The CBM significantly correlated with the FAB (ρ = 0.75; p < .001), 3MTW errors (ρ = − 0.61; p < .001), 3MTW time (ρ = − 0.35; p = .05), the 8-level balance scale (ρ = 0.35; p < .05), the TUG (ρ = − 0.42; p < .01), and 7-m habitual gait speed (ρ = 0.46, p < .001). Inter- (ICC2,k = 0.97), intrarater reliability (ICC3,k = 1.00) were excellent, and internal consistency (α = 0.88; ρ = 0.28–0.81) was good to satisfactory. The CBM did not show ceiling effects in contrast to other scales. Conclusions: Concurrent validity of the CBM was good when compared to the FAB and moderate to good when compared to other measures of balance and mobility. Based on this study, the CBM can be recommended to measure balance and mobility performance in the specific population of young-older adults. Trial registration Trial number: ISRCTN37750605 . (Registered on 21/04/2016)

    Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons: a randomized noninferiority trial

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    Background: The Lifestyle-Integrated Functional Exercise (LiFE) program is effective in improving strength, balance, and physical activity (PA) while simultaneously reducing falls in older people by incorporating exercise activities in recurring daily tasks. However, implementing the original LiFE program includes substantial resource requirements. Therefore, as part of the LiFE-is-LiFE project, a group format (gLiFE) of the LiFE program has been developed, which will be tested regarding its noninferiority to the individually delivered LiFE in terms of PA-adjusted fall incidence and overall cost-effectiveness. Methods: In a multi-centre, single-blinded noninferiority trial, an envisaged sample of N = 300 participants (> 70 years; faller and/or confirmed falls risk; community-dwelling) will be randomized in either LiFE or gLiFE. Both groups will undergo the same strength and balance activities as well as PA promotion activities and habitualization strategies as described in the LiFE programme, however, based on different approaches of delivery: During the 6-month intervention phase, LiFE participants will receive seven home visits and two telephone calls; in gLiFE, the program will be delivered in seven group sessions and also two telephone calls. Main outcomes are a) fall incidence per PA and b) incremental cost-effectiveness ratio comparing costs and quality-adjusted life years between the two interventions. Secondary outcomes include PA behaviour, motor performance, health status, psychosocial status, program evaluation, and adherence. Measurements will be conducted at baseline, 6-month and 12-month follow-up; evaluation of intervention sessions and assessment of psychosocial variables related to execution and habitualization of LiFE activities will be made during the intervention period as well. Discussion: Compared to LiFE, we expect gLiFE to (a) reduce falls per PA by a similar rate; (b) be more cost-effective; (c) comparably enhance physical performance in terms of strength and balance as well as PA. By investigating the economic and societal benefit, this study will be of high practical relevance as noninferiority of gLiFE would facilitate large-scale implementation due to lower resource usage. This would result in better reach and increased accessibility, which is important for subjects with a history of falls and/or being at risk of falls. Trial registration ClinicalTrials.gov NCT03462654. Registered on March 12, 2018

    Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a randomised, controlled, multicentre trial

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    Abstract Background The incidence of proximal humeral fractures increases with age. The functional recovery of the upper arm after such fractures is slow, and results are often disappointing. Treatment is associated with long immobilisation periods. Evidence-based exercise guidelines are missing. Loss of muscle mass as well as reduced range of motion and motor performance are common consequences. These losses could be partly counteracted by training interventions using robot-assisted arm support of the affected arm derived from neurorehabilitation. Thus, shorter immobilisation could be reached. Thus far, this approach has been tested in only a few small studies. The aim of the present study is to examine whether assistive robotic training augmenting conventional occupational and physical therapy can improve functional shoulder outcomes. Methods/design Patients aged between 35 and 66 years with proximal humeral fracture and surgical treatment will be recruited at three different clinics in Germany and randomised into an intervention group and a control group. Participants will be assessed before randomisation and followed after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. The baseline assessment will include cognition (Short Orientation-Memory-Concentration Test); level of pain in the affected arm; ability to work; gait speed (10-m walk); disability of the arm, shoulder and hand (Disabilities of the Arm, Shoulder and Hand Outcome Measure [DASH]); range of motion of the affected arm (goniometer measurement); visual acuity; and motor function of orthopaedic patients (Wolf Motor Function Test–Orthopaedic version [WMFT-O]). Clinical follow-up directly after the intervention will include assessment of disability of the arm, shoulder and hand (DASH) as well as range of motion and motor function (WMFT-O). The primary outcome parameter will be the DASH, and the secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by postal follow-up. All patients will receive conventional occupational and physical therapy. The intervention group will receive additional robot-assisted training using the Armeo®Spring robot for 3 weeks. Discussion This study protocol describes a phase II, randomised, controlled, single-blind, multicentre intervention study. The results will guide and possibly improve methods of rehabilitation after proximal humeral fracture. Trial registration Clinicaltrials.gov, NCT03100201 . Registered on 28 March 2017

    Group-Based and Individually Delivered LiFE : Content Evaluation and Predictors of Training Response : A Dose-Response Analysis

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    Introduction: Lifestyle-integrated Functional Exercise (LiFE) is an effective, individually delivered fall prevention program but comes with substantial resource requirements; hence, a group-format was developed (gLiFE). This study 1) evaluates the program content of two different LiFE formats (group vs individual) and 2) examines the relationship between predictors of training response (dose) and improvements in balance, strength, and physical activity (PA) (response).Material and Methods: The analysis included n = 252 (gLiFE = 126, LiFE = 126) community-dwelling older adults (78.6± 5.2 years). LiFE was administered in seven sessions either in a group (gLiFE: 8– 12 participants) or individually at home (LiFE). Questionnaire-based, descriptive content evaluation (frequency distributions) included reported frequency of practice (days/week, number of activities), activity preferences, safety, intensity, integrability of activities, and acceptance after 6 months of LiFE practice. Predictors (ie, dose [reported frequency and intensity], safety, and integrability of activities) for improvements in balance, strength, and PA were analyzed using radar charts.Results: In both formats, 11.2 activities were practiced on average. Strength activities were more frequently selected than balance. Content evaluation showed some marginal advantages for the LiFE participants for selected aspects. The effects on balance, strength, and PA were nearly similar in both groups. Participants who performed balance activities more frequently (≥ 4 days/week) scored better in the balance and PA domain. Those who performed strength activities more frequently (≥ 4 days/week) performed better in all three outcomes. Higher perceived safety was associated with better performance. Those who reported activities as “not physically exhausting” performed better in all three outcomes. Those who found activities easily integrable into daily routines scored higher in the balance and strength domain.Discussion and Conclusion: Overall, both program formats are comparable with respect to content evaluation and effects. Participants need to perceive the activities as safe, not exhausting, and should practice ≥ 4 days/week to generate a high benefit from the intervention.Trial Registration: ClinicalTrials.gov, NCT03462654. Registered on 12 March 2018.publishe

    Development of a conceptual framework for a group-based format of the Lifestyle-integrated Functional Exercise (gLiFE) programme and its initial feasibility testing

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    Background:The Lifestyle-integrated Functional Exercise (LiFE) programme is a fall prevention programme originally taught in a resource-intensive one-to-one format with limited feasibility for large-scale implementation. The aim of this paper is to present the conceptual framework and initial feasibility evaluation of a group-based LiFE (gLiFE) format developed for large-scale implementation.Methods:The conceptual gLiFE framework (part I) is based on three pillars, LiFE Activities and Principles, Theory of Behaviour Change and Behaviour Change Techniques, and Instruction. The feasibility of gLiFE was tested (part II) within a multimodal approach including quantitative questionnaires measuring safety, acceptability (1 = best to 7 = insufficient), and adherence to the LiFE activities (range = 0–14) as well as a focus group interview. Exploratory self-reported measures on behaviour change including self-determined motivation (range = 1–5), intention, planning, action control, and habit strength (range = 1–6) were assessed pre and post intervention. Data analyses were performed using descriptive statistics and qualitative content analysis.Results:The development process resulted in a manualised gLiFE concept containing standardised information on gLiFE’s content and structure. Feasibility testing: Six older adults (median = 72.8 years, 5 female) completed the feasibility study and rated safety (median = 7.0, IQR = 0.3) and acceptability as high (median = 1, IQR = 1). Participants implemented 9.5 LiFE activities (IQR = 4.0) into their daily routines. No adverse events occurred during the study. In the focus group, the group format and LiFE activities were perceived as positive and important for maintaining strength and balance capacity. Self-determined motivation intention, planning, and habit strength were rated higher post intervention.Conclusion:The developed conceptual gLiFE framework represents the basis for a gLiFE format with potential for standardised large-scale implementation. Proof-of-concept could be demonstrated in a group of community-dwelling older adults at risk of falling. The public health potential of gLiFE in terms of (cost-)effectiveness is currently being evaluated in a large trial.Trial registration:ClinicalTrials.gov NCT03412123. Registered on January 26, 2018publishe

    Mediating factors on the association between fear of falling and health-related quality of life in community-dwelling German older people : a cross-sectional study

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    Background:Previous research has shown that not only falls, but also fear of falling (FoF) influences health-related quality of life (HrQoL) negatively. The EQ-5D (consisting of an index and a visual analogue scale [EQ-VAS]) is a frequently used instrument to determine HrQoL in clinical studies and economic evaluations, but no previous study compared the association between FoF and the EQ-5D index with the association between FoF and the EQ-VAS. Moreover, factors that influence the association between FoF and HrQoL are rarely examined. Thus, this study aimed to examine the association between FoF and HrQoL and to examine factors that mediate the association.Methods:FoF (Short Falls Efficacy Scale International) and HrQoL (EQ-5D descriptive system, EQ-5D index, and EQ-VAS) were assessed in a sample of community-dwelling older persons (≥70 years) participating in the baseline assessment of a randomized controlled trial (N = 309). Linear and logistic regression analyses were performed, adjusting for sociodemographic variables, frequency of falls, number of chronic conditions, functional mobility (Timed up-and-go test), and subjective functional capacity (LLFDI function and disability scales). Multiple regression models were used to test the mediating effects.Results:Moderate or high FoF was prevalent in 66% of the sample. After adjusting for covariates, FoF was negatively associated with the EQ-5D index, but not with the descriptive system or the EQ-VAS. Subjective functional capacity partly mediated the association between FoF and the EQ-5D index and completely mediated the association between FoF and the EQ-VAS.Conclusion:FoF was negatively associated with the EQ-5D index. As subjective functional capacity mediated the association between FoF and HrQoL, future interventions should account for subjective functional capacity in their design.publishe

    Willingness to pay for a group and an individual version of the Lifestyle-integrated Functional Exercise program from a participant perspective

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    BackgroundPerceived benefits of intervention programs from a participant perspective can be examined by assessing their willingness to pay (WTP). Aiming to support decision-makers in their decision to implement a fall prevention program, this study examined (1) the WTP for a group-based and an individually delivered fall prevention program, (2) which factors influence WTP, and (3) whether the WTP exceeds the intervention costs.MethodsWTP was elicited using Payment Cards from 237 individuals who participated in a randomized non-inferiority trial (LiFE-is-LiFE) comparing a group version of the Lifestyle-integrated Functional Exercise program (gLiFE) with the individually delivered version (LiFE). Linear regression models were used to examine factors associated with WTP. The net benefit for (g)LiFE was calculated as the difference between WTP and intervention costs, assuming different scenarios of intervention costs (varying group sizes of gLiFE) and hypothetical subsidy levels by a payer (€0, €50, or €75).ResultsThe mean WTP was €196 (95% CI [172, 221]) for gLiFE and €228 (95% CI [204, 251]) for LiFE. In the linear regression model, WTP was significantly associated with delivery format (−€32, 95% CI [− 65, − 0.2], for gLiFE) and net household income (+ 68€, 95% CI [23, 113], for ≥€3000 compared to ConclusionThe results provide insight into how valuable the interventions are perceived by the participants and thereby may be used by decision-makers as complement to cost-effectiveness analyses. WTP for both programs was generally high, probably indicating that participants perceived the intervention as quite valuable. However, further research is needed on the WTP and net benefit of fall prevention programs, as results relied on the specific context of the LiFE-is-LiFE trial.publishe

    Association between everyday walking activity, objective and perceived risk of falling in older adults

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    Background:older persons can be grouped according to their objective risk of falling (ORF) and perceived risk of falling (PRF) into ‘vigorous’ (low ORF/PRF), ‘anxious’ (low ORF/high PRF), ‘stoic’ (high ORF/low PRF) and ‘aware’ (high ORF/PRF). Sensor-assessed daily walking activity of these four groups has not been investigated, yet.Objective:we examined everyday walking activity in those four groups and its association with ORF and PRF.Design:cross-sectionalSetting:communitySubjects:N = 294 participants aged 70 years and older.Methods:ORF was determined based on multiple independent risk factors; PRF was determined based on the Short Falls Efficacy Scale-International. Subjects were allocated to the four groups accordingly. Linear regression was used to quantify the associations of these groups with the mean number of accelerometer-assessed steps per day over 1 week as the dependent variable. ‘Vigorous’ was used as the reference group.Results:average number of steps per day in the four groups were 6,339 (‘vigorous’), 5,781 (‘anxious’), 4,555 (‘stoic’) and 4,528 (‘aware’). Compared with the ‘vigorous’, ‘stoic’ (−1,482; confidence interval (CI): −2,473; −491) and ‘aware’ (−1,481; CI: −2,504; −458) participants took significantly less steps, but not the ‘anxious’ (−580 steps; CI: −1,440; 280).Conclusion:we have integrated a digital mobility outcome into a fall risk categorisation based on ORF and PRF. Steps per day in this sample of community-dwelling older persons were in accordance with their ORF rather than their PRF. Whether this grouping approach can be used for the specification of participants’ needs when taking part in programmes to prevent falls and simultaneously promote physical activity remains to be answered in intervention studies.publishe
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