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      Establishing the Minimal Clinically Important Differences for Sagittal Hip Range of Motion in Chronic Stroke Patients

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          Abstract

          Many researchers have pointed out that decreased sagittal range of motion (ROM) in the affected hip joint is a common consequence of stroke, and it adversely affects walking performance and walking speed. Nevertheless, the minimal clinically important differences (MCID) in hip-related kinematic gait parameters post-stroke have not yet been determined. The present study aimed to define MCID values for hip ROM in the sagittal plane i.e., flexion–extension (FE), for the affected and unaffected sides at a chronic stage post-stroke. Fifty participants with hemiparesis due to stroke were enrolled for the study. Four statistical methods were used to calculate MCID. According to the anchor-based approach, the mean change in hip FE ROM achieved by the MCID group on the affected/unaffected side amounted to 5.81°/2.86° (the first MCID estimate). The distribution-based analyses established that the standard error of measurement in the no-change group amounted to 1.56°/1.04° (the second MCID estimate). Measurements based on the third method established that a change of 4.09°/0.61° in the hip ROM corresponded to a 1.85-point change in the Barthel Index. The optimum cutoff value, based on ROC curve analysis, corresponded to 2.9/2.6° of change in the hip sagittal ROM for the affected/unaffected side (the fourth MCID estimate). To our knowledge, this is the first study to use a comprehensive set of statistical methods to determine the MCID for hip sagittal ROM for the affected and unaffected sides at a chronic stage post-stroke. According to our findings, the MCID of the hip FE ROM for the affected side amounts to 5.81° and for the unaffected side to 2.86°, in patients with chronic stroke. This indicator is extremely important because it allows clinical practitioners to assess the effects of interventions administered to patients, and to interpret the significance of improvements in sagittal kinematic parameters of the hip; ultimately, it may facilitate the process of designing effective gait reeducation programs.

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          Most cited references55

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          Measurement of health status. Ascertaining the minimal clinically important difference.

          In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
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            Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes.

            The objective of this review is to summarize recommendations on methods for evaluating responsiveness and minimal important difference (MID) for patient-reported outcome (PRO) measures. We review, summarize, and integrate information on issues and methods for evaluating responsiveness and determining MID estimates for PRO measures. Recommendations are made on best-practice methods for evaluating responsiveness and MID. The MID for a PRO instrument is not an immutable characteristic, but may vary by population and context, and no one MID may be valid for all study applications. MID estimates should be based on multiple approaches and triangulation of methods. Anchor-based methods applying various relevant patient-rated, clinician-rated, and disease-specific variables provide primary and meaningful estimates of an instrument's MID. Results for the PRO measures from clinical trials can also provide insight into observed effects based on treatment comparisons and should be used to help determine MID. Distribution-based methods can support estimates from anchor-based approaches and can be used in situations where anchor-based estimates are unavailable. We recommend that the MID is based primarily on relevant patient-based and clinical anchors, with clinical trial experience used to further inform understanding of MID.
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              Meaningful change and responsiveness in common physical performance measures in older adults.

              To estimate the magnitude of small meaningful and substantial individual change in physical performance measures and evaluate their responsiveness. Secondary data analyses using distribution- and anchor-based methods to determine meaningful change. Secondary analysis of data from an observational study and clinical trials of community-dwelling older people and subacute stroke survivors. Older adults with mobility disabilities in a strength training trial (n=100), subacute stroke survivors in an intervention trial (n=100), and a prospective cohort of community-dwelling older people (n=492). Gait speed, Short Physical Performance Battery (SPPB), 6-minute-walk distance (6MWD), and self-reported mobility. Most small meaningful change estimates ranged from 0.04 to 0.06 m/s for gait speed, 0.27 to 0.55 points for SPPB, and 19 to 22 m for 6MWD. Most substantial change estimates ranged from 0.08 to 0.14 m/s for gait speed, 0.99 to 1.34 points for SPPB, and 47 to 49 m for 6MWD. Based on responsiveness indices, per-group sample sizes for clinical trials ranged from 13 to 42 for substantial change and 71 to 161 for small meaningful change. Best initial estimates of small meaningful change are near 0.05 m/s for gait speed, 0.5 points for SPPB, and 20 m for 6MWD and of substantial change are near 0.10 m/s for gait speed, 1.0 point for SPPB, and 50 m for 6MWD. For clinical use, substantial change in these measures and small change in gait speed and 6MWD, but not SPPB, are detectable. For research use, these measures yield feasible sample sizes for detecting meaningful change.
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                Author and article information

                Contributors
                Journal
                Front Neurol
                Front Neurol
                Front. Neurol.
                Frontiers in Neurology
                Frontiers Media S.A.
                1664-2295
                01 September 2021
                2021
                : 12
                : 700190
                Affiliations
                [1] 1Department of Physiotherapy, Institute of Health Sciences, Medical College, University of Rzeszów , Rzeszów, Poland
                [2] 2Laboratory of Kinematics and Robotics IRCCS San Camillo Hospital , Venice, Italy
                [3] 3Azienda Unità Locale Socio Sanitaria 3 Serenissima Physical Medicine and Rehabilitation Unit , Venice, Italy
                Author notes

                Edited by: Anirban Dutta, University at Buffalo, United States

                Reviewed by: Anke Van Bladel, Ghent University, Belgium; Carmela Conte, IRCCS Don Carlo Gnocchi Firenze, Italy

                *Correspondence: Agnieszka Guzik agnieszkadepa2@ 123456wp.pl

                This article was submitted to Neurorehabilitation, a section of the journal Frontiers in Neurology

                Article
                10.3389/fneur.2021.700190
                8443407
                34539552
                239fa05d-6c5d-45e3-891a-611a520146e8
                Copyright © 2021 Guzik, Drużbicki, Perenc, Wolan-Nieroda, Turolla and Kiper.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 25 April 2021
                : 03 August 2021
                Page count
                Figures: 3, Tables: 3, Equations: 0, References: 56, Pages: 10, Words: 7437
                Categories
                Neurology
                Original Research

                Neurology
                chronic stroke,minimal clinically important difference,hip,range of motion,gait
                Neurology
                chronic stroke, minimal clinically important difference, hip, range of motion, gait

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