Concurrent validity and reliability of wireless instrumented insoles measuring postural balance and temporal gait parameters.

BACKGROUND: The OpenGo seems promising to take gait analysis out of laboratory settings due to its capability of long-term measurements and mobility. However, the OpenGo's concurrent validity and reliability need to be assessed to determine if the instrument is suitable for validation in patient samples. METHODS: Twenty healthy volunteers participated. Center of pressure data were collected under eyes open and closed conditions with participants performing unilateral stance trials on the gold standard (AMTI OR6-7 force plate) while wearing the OpenGo. Temporal gait data (stance time, gait cycle time, and cadence) were collected at a self-selected comfortable walking speed with participants performing test-retest trials on an instrumented treadmill while wearing the OpenGo. Validity was assessed using Bland-Altman plots. Reliability was assessed with Intraclass Correlation Coefficient (2,1) and smallest detectable changes were calculated. FINDINGS: Negative means of differences were found in all measured parameters, illustrating lower scores for the OpenGo on average. The OpenGo showed negative upper limits of agreement in center of pressure parameters on the mediolateral axis. Temporal reliability ICCs ranged from 0.90-0.93. Smallest detectable changes for both stance times were 0.04 (left) and 0.05 (right) seconds, for gait cycle time 0.08s, and for cadence 4.5 steps per minute. INTERPRETATION: The OpenGo is valid and reliable for the measurement of temporal gait parameters during walking. Measurements of center of pressure parameters during unilateral stance are not considered valid. The OpenGo seems a promising instrument for clinically screening and monitoring temporal gait parameters in patients, however validation in patient populations is needed.

Biofeedback in Partial Weight Bearing: Usability of Two Different Devices from a Patient's and Physical Therapist's Perspective.

BACKGROUND: Partial weight bearing is frequently instructed by physical therapists in patients after lower-limb trauma or surgery. The use of biofeedback devices seems promising to improve the patient's compliance with weight-bearing instructions. SmartStep and OpenGo-Science are biofeedback devices that provide real-time feedback. For a successful implementation, usability of the devices is a critical aspect and should be tested from a user's perspective. AIM: To describe the usability from the physical therapists' and a patients' perspective of Smartstep and OpenGo-Science to provide feedback on partial weight bearing during supervised rehabilitation of patients after lower-limb trauma or surgery. METHODS: In a convergent mixed-methods design, qualitative and quantitative data were collected. Usability was subdivided into user performance, satisfaction and acceptability. Patients prescribed with partial weight bearing and their physical therapists were asked to use SmartStep and OpenGo-Science during supervised rehabilitation. Usability was qualitatively tested by a think-aloud method and a semi-structured interview and quantitatively tested by the System-Usability-Scale (SUS) and closed questions. For the qualitative data thematic content analyses were used. RESULTS: Nine pairs of physical therapists and their patients participated. The mean SUS scores for patients and physical therapists were for SmartStep 70 and 53, and for OpenGo-Science 79 and 81, respectively. Scores were interpreted with the Curved Grading Scale. The qualitative data showed that there were mixed views and perceptions from patients and physical therapists on satisfaction and acceptability. CONCLUSION: This study gives insight in the usability of two biofeedback devices from the patient's and physical therapist's perspective. The overall usability from both perspectives seemed to be acceptable for OpenGo-Science. For SmartStep, overall usability seemed only acceptable from the patient's perspective. IMPLICATION: The study findings could help clinicians to decide which biofeedback device is appropriate for their given situation and provide information for future development of biofeedback devices.

Biofeedback in Partial Weight Bearing: Validity of 3 Different Devices.

Study Design Controlled laboratory study to assess criterion-related validity, with a cross-sectional within-subject design. Background Patients with orthopaedic conditions have difficulties complying with partial weight-bearing instructions. Technological advances have resulted in biofeedback devices that offer real-time feedback. However, the accuracy of these devices is mostly unknown. Inaccurate feedback can result in incorrect lower-limb loading and may lead to delayed healing. Objectives To investigate validity of peak force measurements obtained using 3 different biofeedback devices under varying levels of partial weight-bearing categories. Methods Validity of 3 biofeedback devices (OpenGo science, SmartStep, and SensiStep) was assessed. Healthy participants were instructed to walk at a self-selected speed with crutches under 3 different weight-bearing conditions, categorized as a percentage range of body weight: 1% to 20%, greater than 20% to 50%, and greater than 50% to 75%. Peak force data from the biofeedback devices were compared with the peak vertical ground reaction force measured with a force plate. Criterion validity was estimated using simple and regression-based Bland-Altman 95% limits of agreement and weighted kappas. Results Fifty-five healthy adults (58% male) participated. Agreement with the gold standard was substantial for the SmartStep, moderate for OpenGo science, and slight for SensiStep (weighted ± = 0.76, 0.58, and 0.19, respectively). For the 1% to 20% and greater than 20% to 50% weight-bearing categories, both the OpenGo science and SmartStep had acceptable limits of agreement. For the weight-bearing category greater than 50% to 75%, none of the devices had acceptable agreement. Conclusion The OpenGo science and SmartStep provided valid feedback in the lower weight-bearing categories, and the SensiStep showed poor validity of feedback in all weight-bearing categories. J Orthop Sports Phys Ther 2016;46(11):-1. Epub 12 Oct 2016. doi:10.2519/jospt.2016.6625.

REPRODUCIBILITY OF THE MODIFIED STAR EXCURSION BALANCE TEST COMPOSITE AND SPECIFIC REACH DIRECTION SCORES.

BACKGROUND: The mSEBT is a screening tool used to evaluate dynamic balance. Most research investigating measurement properties focused on intrarater reliability and was done in small samples. To know whether the mSEBT is useful to discriminate dynamic balance between persons and to evaluate changes in dynamic balance, more research into intra- and interrater reliability and smallest detectable change (synonymous with minimal detectable change) is needed. PURPOSE: To estimate intra- and interrater reliability and smallest detectable change of the mSEBT in adults at risk for ankle sprain. STUDY DESIGN: Cross-sectional, test-retest design. METHODS: Fifty-five healthy young adults participating in sports at risk for ankle sprain participated (mean ± SD age, 24.0 ± 2.9 years). Each participant performed three test sessions within one hour and was rated by two physical therapists (session 1, rater 1; session 2, rater 2; session 3, rater 1). Participants and raters were blinded for previous measurements. Normalized composite and reach direction scores for the right and left leg were collected. Analysis of variance was used to calculate intraclass correlation coefficient values for intra- and interrater reliability. Smallest detectable change values were calculated based on the standard error of measurement. RESULTS: Intra- and interrater reliability for both legs was good to excellent (intraclass correlation coefficient ranging from 0.87 to 0.94). The intrarater smallest detectable change for the composite score of the right leg was 7.2% and for the left 6.2%. The interrater smallest detectable change for the composite score of the right leg was 6.9% and for the left 5.0%. CONCLUSION: The mSEBT is a reliable measurement instrument to discriminate dynamic balance between persons. Most smallest detectable change values of the mSEBT appear to be large. More research is needed to investigate if the mSEBT is usable for evaluative purposes. LEVEL OF EVIDENCE: Level 2.

Fatigue in knee and hip osteoarthritis: the role of pain and physical function.

OBJECTIVES: It is suggested that serious levels of fatigue are present in nearly half of patients with OA. However, it is unclear which dimensions of fatigue are involved, if fatigue is related to pain and physical function, and if fatigue is influenced by therapy. The aims of this study were to measure levels of different dimensions of fatigue before and after evidenced-based conservative treatment and to investigate the association between fatigue and pain and physical function in patients with knee or hip OA. METHODS: In this observational cohort study, levels of different dimensions of fatigue were measured in knee and/or hip OA patients before and after 12 weeks of conservative treatment. Cross-sectional and longitudinal relations between (change in) fatigue dimensions and (change in) pain or physical function were studied using association models, controlling for predefined possible confounders. RESULTS: A total of 231 patients was included, with 47% experiencing severe fatigue. A small decrease in levels of fatigue was seen after standardized treatment. The level of fatigue severity was cross-sectionally and longitudinally associated with physical function, whereas the level of physical fatigue was cross-sectionally and longitudinally associated with pain and physical function. No confounders were identified. CONCLUSIONS: Important levels of fatigue are common in knee and hip OA patients. After evidence-based tailored conservative treatment targeted to improve pain and physical function, a small decrease in fatigue levels was found. Reduction in levels of different fatigue dimensions were related to the change in physical function and pain.

Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial.

BACKGROUND: Non-pharmacological treatment (NPT) is a useful treatment option in the management of hip or knee osteoarthritis. To our knowledge however, no studies have investigated the effect of NPT in patients with generalized osteoarthritis (GOA). The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA. The secondary objective is to compare the cost-effectiveness of both interventions. METHODS/DESIGN: In this randomized, single blind, clinical trial with active controls, we aim to include 170 patients with GOA. The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team (occupational therapist, physiotherapist, dietician and specialized nurse). The active control group consists of two group sessions and four sessions by telephone, provided by a specialized nurse and physiotherapist. Both therapies last six weeks. Main study outcome is daily functioning during the first year after the treatment, assessed on the Health Assessment Questionnaire. Secondary outcomes are health related quality of life, specific complaints, fatigue, and costs. Illness cognitions, global perceived effect and self-efficacy, will also be assessed for a responder analysis. Outcome assessments are performed directly after the intervention, after 26 weeks and after 52 weeks. DISCUSSION: This article describes the design of a randomized, single blind, clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA. TRIAL REGISTRATION: Dutch Trial Register NTR2137.